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Amitraz
CASRN 33089-61-1
Contents
0334
Amitraz; CASRN 33089-61-1
Health assessment information on a chemical substance is included in IRIS only
after a comprehensive review of chronic toxicity data by U.S. EPA health
scientists from several Program Offices and the Office of Research and
Development. The summaries presented in Sections I and II represent a
consensus reached in the review process. Background information and
explanations of the methods used to derive the values given in IRIS are
provided in the Background Documents.
STATUS OF DATA FOR Amitraz
File On-Line 08/22/1988
Category (section) Status Last Revised
----------------------------------------- -------- ------------
Oral RfD Assessment (I.A.) on-line 12/01/1988
Inhalation RfC Assessment (I.B.) no data
Carcinogenicity Assessment (II.) no data
_I. CHRONIC HEALTH HAZARD ASSESSMENTS FOR NONCARCINOGENIC EFFECTS
__I.A. REFERENCE DOSE FOR CHRONIC ORAL EXPOSURE (RfD)
Substance Name -- Amitraz
CASRN -- 33089-61-1
Primary Synonym -- BTS 27 419
Last Revised -- 12/01/1988
The oral Reference Dose (RfD) is based on the assumption that thresholds exist
for certain toxic effects such as cellular necrosis. It is expressed in units
of mg/kg-day. In general, the RfD is an estimate (with uncertainty spanning
perhaps an order of magnitude) of a daily exposure to the human population
(including sensitive subgroups) that is likely to be without an appreciable
risk of deleterious effects during a lifetime. Please refer to the Background
Document for an elaboration of these concepts. RfDs can also be derived for
the noncarcinogenic health effects of substances that are also carcinogens.
Therefore, it is essential to refer to other sources of information concerning
the carcinogenicity of this substance. If the U.S. EPA has evaluated this
substance for potential human carcinogenicity, a summary of that evaluation
will be contained in Section II of this file.
___I.A.1. ORAL RfD SUMMARY
Critical Effect Experimental Doses* UF MF RfD
-------------------- ----------------------- ----- --- ---------
Increased mean blood NOEL: 0.25 mg/kg/day 100 1 2.5E-3
sugar concentration; mg/kg/day
slight hypothermia LEL: 1.0 mg/kg/day
2-Year Dog Oral
Feeding Study
Upjohn Co., 1972a
*Conversion Factors: 1 ppm = 0.025 mg/kg/day (assumed dog food consumption)
___I.A.2. PRINCIPAL AND SUPPORTING STUDIES (ORAL RfD)
Upjohn Company. 1972a. MRID No. 00030493, 00040856. Available from EPA.
Write to FOI, EPA, Washington, DC 20460.
Groups of 8 beagle dogs (4/sex/dose level) were given 0.1, 0.25, and 1
mg/kg/day of amitraz for 2 years. All eight dogs given 1 mg/kg/day exhibited
signs of slight CNS depression 3 hours after dosing on days 1 and 2, and all
appeared normal again by the following morning. One male receiving 1
mg/kg/day had a slight subnormal temperature at 3 hours which returned to
normal within 24 hours. All dogs in this group appeared clinically normal,
except one female that was slightly hypothermic 3 hours after dosing during
weeks 52 and 79. Blood samples were collected during weeks 40 and 53 showed
significant increase in mean blood sugar concentration 3 hours after dosing in
the 1 mg/kg/day group. No clinical reactions to treatment were seen in dogs
at lower dosages.
___I.A.3. UNCERTAINTY AND MODIFYING FACTORS (ORAL RfD)
UF -- An uncertainty factor of 100 was used, 10 each to account for the inter-
and intraspecies differences.
MF -- None
___I.A.4. ADDITIONAL COMMENTS (ORAL RfD)
Data Considered for Establishing the RfD
1) 2-Year Feeding - dog: Principal study - see previous description; core
grade minimum
2) 2-Year Feeding - rat: Systemic NOEL=50 ppm (2.5 mg/kg/day); Systemic
LEL=200 ppm (10 mg/kg/day) (HDT; temporarily depressed food intake, depressed
growth rate, nervous, aggressive, excitable); core grade minimum (Upjohn Co.,
1973a)
3) 3-Generation Reproduction - rat: NOEL=15 ppm (1.6 mg/kg/day); Systemic
LEL=50 ppm (5 mg/kg/day (increase mortality during suckling period; decreased
litter size); core grade minimum (Boots Hercules Agrochemicals Co., 1980)
4) Teratology - rat: NOEL=12 mg/kg/day (HDT); core grade minimum (Upjohn Co.,
1973b)
5) Teratology - rabbit: Teratogenic NOEL=25 mg/kg/day (frank maternal
toxicity at higher levels precluded a teratogenic assessment); Maternal
NOEL=25 mg/kg/day; Maternal LEL=50 mg/kg/day (mortality); Fetotoxic NOEL=25
mg/kg/day; Fetotoxic LEL=50 mg/kg/day (mortality); no core grade (Boots
Hercules Agrochemicals Co., 1973)
6) Teratology - rabbit: Teratogenic NOEL=25 mg/kg/day (HDT); Teratogenic
LEL=none; Fetotoxic NOEL=1 mg/kg/day; Fetotoxic LEL=5 mg/kg/day (one cleft
palate, meningocoele associated with small ears and displaced toe); no core
grade (Upjohn Co., 1973c)
Other Data Reviewed:
1) 90-Day Feeding - dog: NOEL=0.25 mg/kg/day; LEL=1 mg/kg/day (CNS
depression, decreased rectal temperature, decreased pulse, increased blood
sugar, neutrophilia in bone marrow, slight enlargement of central and midzonal
hepatocytes, hyperplasia of zona glomerulosa with decrease in zona fasiculata
and reticularis); core grade minimum (Upjohn Co., 1973d)
2) 90-Day Feeding - rat: NOEL=3 mg/kg/day; LEL=12 mg/kg/day (depressed body
weight gain, increased brain to body weight ratio); core grade supplementary
(Upjohn Co., 1971)
3) 90-Day Feeding - mouse: NOEL=3 mg/kg/day; LEL=12 mg/kg/day (decreased body
weight gain, increased heart weight); core grade minimum (Upjohn Co., 1972b)
Data Gap(s): None
___I.A.5. CONFIDENCE IN THE ORAL RfD
Study -- Medium
Data Base -- Medium
RfD -- Medium
The critical study is of adequate quality and is given a medium confidence
rating. Additional studies are supportive and of fair quality and therefore
the data base is given a medium confidence rating. Medium confidence in the
RfD follows.
___I.A.6. EPA DOCUMENTATION AND REVIEW OF THE ORAL RfD
Source Document -- This assessment is not presented in any existing U.S. EPA
document.
Other EPA Documentation -- Pesticide Registration Files
Agency Work Group Review -- 10/14/1987
Verification Date -- 10/14/1987
___I.A.7. EPA CONTACTS (ORAL RfD)
Please contact the Risk Information Hotline for all questions concerning this
assessment or IRIS, in general, at (513)569-7254 (phone), (513)569-7159 (FAX)
or RIH.IRIS@EPAMAIL.EPA.GOV (internet address).
__I.B. REFERENCE CONCENTRATION FOR CHRONIC INHALATION EXPOSURE (RfC)
Substance Name -- Amitraz
CASRN -- 33089-61-1
Primary Synonym -- BTS 27 419
Not available at this time.
_II. CARCINOGENICITY ASSESSMENT FOR LIFETIME EXPOSURE
Substance Name -- Amitraz
CASRN -- 33089-61-1
Primary Synonym -- BTS 27 419
This substance/agent has not undergone a complete evaluation and determination
under US EPA's IRIS program for evidence of human carcinogenic potential.
_VI. BIBLIOGRAPHY
Substance Name -- Amitraz
CASRN -- 33089-61-1
Primary Synonym -- BTS 27 419
Last Revised -- 10/01/1989
__VI.A. ORAL RfD REFERENCES
Boots Hercules Agrochemicals Company. 1973. MRID No. 00029961. Available
from EPA. Write to FOI, EPA, Washington D.C. 20460.
Boots Hercules Agrochemicals Company. 1980. MRID No. 00029960, 00029962.
Available from EPA. Write to FOI, EPA, Washington D.C. 20460.
Upjohn Company. 1971. MRID No. 00051784. Available from EPA. Write to FOI,
EPA, Washington D.C. 20460.
Upjohn Company. 1972a. MRID No. 00030493, 00040856. Available from EPA.
Write to FOI, EPA, Washington D.C. 20460.
Upjohn Company. 1972b. MRID No. 00072818, 00133930. Available from EPA.
Write to FOI, EPA, Washington D.C. 20460.
Upjohn Company. 1973a. MRID No. 00041197, 00044585. Available from EPA.
Write to FOI, EPA, Washington D.C. 20460.
Upjohn Company. 1973b. MRID No. 00040856. Available from EPA. Write to
FOI, EPA, Washington D.C. 20460.
Upjohn Company. 1973c. MRID No. 00040860. Available from EPA. Write to
FOI, EPA, Washington D.C. 20460.
Upjohn Company. 1973d. MRID No. 00040345. Available from EPA. Write to
FOI, EPA, Washington D.C. 20460.
__VI.B. INHALATION RfD REFERENCES
None
__VI.C. CARCINOGENICITY ASSESSMENT REFERENCES
None
_VII. REVISION HISTORY
Substance Name -- Amitraz
CASRN -- 33089-61-1
Primary Synonym -- BTS 27 419
-------- -------- --------------------------------------------------------
Date Section Description
-------- -------- --------------------------------------------------------
08/22/1988 I.A. Oral RfD summary on-line
12/01/1988 I.A.4. Core grades corrected
10/01/1989 VI. Bibliography on-line
01/01/1992 IV. Regulatory Action section on-line
VIII. SYNONYMS
Substance Name -- Amitraz
CASRN -- 33089-61-1
Primary Synonym -- BTS 27 419
Last Revised -- 08/22/1988
33089-61-1
Amitraz
amitraze
amitraz estrella
azadieno
BAAM
Boots BTS 27419
BTS 27 419
1,5-di(2,4-dimethylphenyl-3-methyl-1,3,5-triazapenta-1,4-diene
ENT 27967
methanimidamide, N'-(2,4-dimethylphenyl)-N-(((2,4-dimethylphenyl)imino)methyl)
-N-methyl-
2-methyl-1,3-di(2,4-xylylimino)-2-azapropane
mitaban
mitac
N'-(2,4-dimethylphenyl)-N-(((2,4-dimethylphenyl)imino)methyl)-N-
methylmethanimidamide
N-methyl-bis(2,4-xylyliminomethyl)amine
N-methyl-N'-2,4-xylyl-N-(N-2,4-xylylformimidoyl)formamidine
N,N-bis(2,4-xylyliminomethyl)methylamine
N,N-di-(2,4-xylyliminomethyl)methylamine
N,N'-((methylimino)dimethylidyne)di-2,4-xylidine
R.D. 27419
taktic
triatox
U-36059
Upjohn U-36059
2,4-xylidine, N,N'-(methyliminodimethylidyne)bis-
Last updated: 5 May 1998
URL: http://www.epa.gov/iris/SUBST/0334.HTM
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