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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
repeated dose toxicity: oral
Remarks:
combined repeated dose and carcinogenicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: read-across with cycloate ( CAS: 1134-23-2)
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EPA Pesticide Assessment Guidelines 1984
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
S-ethyl N-cyclohexylthiocarbamate
EC Number:
214-482-7
EC Name:
S-ethyl N-cyclohexylthiocarbamate
Cas Number:
1134-23-2
IUPAC Name:
S-ethyl cyclohexyl(ethyl)thiocarbamate

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
2 years
Doses / concentrations
Remarks:
Doses / Concentrations:
0,14,28,58 mg/kg/bw
Basis:
nominal in diet
No. of animals per sex per dose:
10 male and 10 female
Control animals:
yes

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
no effects observed
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
not examined
Details on results:
At the end of 6 months of treatment the no observed adversed effect level is 58 mg/kg body weight nominal.

Effect levels

Dose descriptor:
NOAEL
Effect level:
ca. 58 mg/kg bw/day (nominal)
Based on:
test mat.
Remarks:
cycloate ( read-across tiocarbamate)
Sex:
male/female
Basis for effect level:
other: At 6 months of sampling

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
We used the results of 6 -month sampling of carcinogen tests of cycloate for the detemination of NOAEL of EPTC, which is 58 mg/kgbw.
Executive summary:

We used the results of 6 -month sampling of carcinogen tests of cycloate for the detemination of NOAEL of EPTC, which is 58 mg/kgbw.