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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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 acceptable restrictions mostly due to reduced documentatin in times before GLP.

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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
2 animals only
GLP compliance:
no

Test material

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:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach (Germany)
- Weight at study initiation: 3,34 kg (male) and 2,69 kg (female)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
A cloth (1 x 1 cm) soaked with test substance was applied on one flank of thie animal. The other flank of the same animal served as control.
Duration of treatment / exposure:
4 h
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
A cloth (1 x 1 cm) soaked with test substance was applied and fixed

REMOVAL OF TEST SUBSTANCE
After 4 h the test substance was washed away with lutrol

SCORING SYSTEM:
Etrythema: 1 = questionable; 2 = slight; 3 = strong, 4 = very strong effect
Edema: 1 = very slight; 2 = slight; 3 = strong, 4 = very strong effect

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
Erythema have described as large and in areas surrounding the application site. Full thickness necrosis (histology) as well as crust scars and scale formation have been observed.

Applicant's summary and conclusion

Executive summary:

The study is similar to OECD 404 and reliable with acceptable restrictions mostly due to reduced documentation in times before GLP. A cloth (1 x 1 cm) soaked with test substance was applied onto the skin of two rabbits. After 4 h the test substance was washed away. Strong erythema described as large and in areas surrounding the application site and slight edema have been noted. Beyond this Full thickness necrosis as well as crust scars and scale formation have been observed. Effects were not fully reversible with in 8 days.

Conclusion

4 -tert.-butylcyclohexylchroformate is corrosive to skin.