2,2-bis[(allyloxy)methyl]butyl (3-{[({2,2-bis[(allyloxy)methyl]butoxy}carbonyl)amino]methyl}-3,5,5-trimethylcyclohexyl)carbamate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 August 2009 to 20 October 2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: the Guidelines for the Testing of Chemicals Section 4: Health Effects (ministry of environmental protection of People's Republic of China).

Deviations:

no

GLP compliance:

not specified

Remarks:

Not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-bis[(allyloxy)methyl]butyl (3-{[({2,2-bis[(allyloxy)methyl]butoxy}carbonyl)amino]methyl}-3,5,5-trimethylcyclohexyl)carbamate

EC Number:

946-937-7

Molecular formula:

C36H62N2O8

IUPAC Name:

2,2-bis[(allyloxy)methyl]butyl (3-{[({2,2-bis[(allyloxy)methyl]butoxy}carbonyl)amino]methyl}-3,5,5-trimethylcyclohexyl)carbamate

Test material form:

liquid

Details on test material:

- Storage: cool and dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 216 to 230 g
- Acclimation period: 5 days prior to the test

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24ºC
- Humidity: 50 To 70%

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: a 4 x 5 cm^2 shaven area on the back of the animals
- Type of wrap if used: the application sites were covered with one layer of gauze and two layers of plastic film. The film was fixed with adhesive tape tightly to the animals.

REMOVAL OF TEST SUBSTANCE
- After 24 hours, coverings were removed and the application sites were rinsed completely with warm water and dried with paper towels.

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

yes, concurrent no treatment

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Following dosing, every animal was observed at 0.5 and 4 hours after administration and at least once daily in the following days. Clinical symptoms were recorded. Animals were observed for 14 days after dosing. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was done in conjunction with this study.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality during the study.

Clinical signs:

No clinical signs were observed during the observation time.

Body weight:

Body weights of the treated animals increased during the study.

Gross pathology:

No obvious abnormalities were observed during the gross necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of the study, the LD50 was determined to be greater than 2000 mg/kg bw.

Executive summary:

The acute dermal toxicity of the test material was investigated in accordance with the Guidelines for the Testing of Chemicals Section 4: Health Effects (ministry of environmental protection of People's Republic of China). Five male and five female Sprague-Dawley rats were treated with a 2000 mg/kg bw dose of the test material on a 4 x 5 cm² shaven area on their backs. The application sites were covered with one layer of gauze and two layers of plastic film and after 24 hours, the coverings were removed and the application sites were rinsed completely with warm water and dried with paper towels. Animals were observed for 14 days after dosing. There was no mortality during the study and no clinical signs were observed during the observation time. Body weights of the treated animals increased during the study and no obvious abnormalities were observed during the gross necropsy. Under the conditions of the study, the LD50 was determined to be greater than 2000 mg/kg bw.