4-tert-butylcyclohexyl chloroformate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is reliable with acceptabe restrictions mostly due to limited documentation (e.g. body weight only determined for dose calculation prior to application) and fewer animals used in the high dose group.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-tert-butylcyclohexyl carbonochloridic acid ester

IUPAC Name:

4-tert-butylcyclohexyl carbonochloridic acid ester

Constituent 2

Reference substance name:

77/808

IUPAC Name:

77/808

Details on test material:

- Name of test material (as cited in study report): 4-tert.-ButylcyclohexylchlorKohlensäureester ( 4-tert-butylcyclohexyl carbonochloridic acid ester)
- Physical state: clear liquid
- Analytical purity: 98 %
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: not reported

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Wiga, Ottobrunn (Germany)
- Weight at study initiation: mean male 172,5 ± 19 g, mean female 160,4 ± 24 g
- Fasting period before study: yes
no further information given

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Type of coverage:

not specified

Vehicle:

olive oil

Details on dermal exposure:

TEST SITE
- Area of exposure: Back
- % coverage: 2-15 cm2 depending on the dose

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,12-0,30 g/animal of a 50 % Solution in olive oil (vehicle) depening on the dose

Duration of exposure:

It is not reported wether the test substance was removed after application.

Doses:

400, 1000, 2000 mg/kg

No. of animals per sex per dose:

400 and 1000 mg/kg: 5
2000 mg/kg: 3

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: only prior to application for dose calculation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

none, but not necessary due to the result

Results and discussion

Effect levels

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no animal died

Clinical signs:

other: No substance related clinical signs besides skin irritating/caustic effect were noted. Behavior of all animals was described as "vivid".

Gross pathology:

No substance related findings were observed.

Applicant's summary and conclusion

Executive summary:

The study is reliable with acceptabe restrictions mostly due to limited documentation (e.g. body weight only determined for dose calculation prior to application). A dose of 400, 1000, 2000 mg/kg of the test substance (50 % in olive oil) was applied on the back of Sprague Dawley rats. 5 animals per sex were used in the 400 and 1000 mg/kg dose groups, but only 3 animals per sex were used in the 2000 mg/kg dose group (limit dose). No motrality nor any substance related clinical finding, besides a skin irritating/caustic effect was noted.

Conclusion

4-tert.-butylcyclohexyl chlorformiate is practically non toxic when in contact with skin.