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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Proposal of Limit Concentrations for Skin Irritation within the Context of a New EEC Directive on the Classification and Labeling of Preparations.
Author:
Jacobs G, Martens M, Mosselmans G
Year:
1987
Bibliographic source:
Regulatory Toxicology and Pharmacology 7, 370-378.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS:
- Strain: Rabbit / New Zealand White / White of Dendermont
- Breeder: Proefstations voor Veetelt (Merelbeke, Belgium)
- Number and sex: 5-6 animals
- Body weigth: 2.75 - 5.2 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: almond oil
Controls:
yes, concurrent no treatment
yes, concurrent vehicle
Amount / concentration applied:
0.5 mL
Concentration: 100% (w/w)
Duration of treatment / exposure:
4 hours
Observation period:
4 weeks
Number of animals:
5 to 6
Details on study design:
The exposure time was 4 hours. Afterwards, the patch was removed and the skin was cleaned using detergent solution and water to remove any residual substance. The animals were examined for signs of erythema and edema formation at 1, 24, 48, and 72 hr after treatment.

Results and discussion

In vivo

Irritant / corrosive response data:
Under the conditions of the test, all monochlorinated hydrocarbons and all monobrominated hydrocarbons with the exception of 1-Bromohexadecane were found to be irritating to the skin. There seems to be a tendency of decreasing irritancy at increasing molecular weigth, which has also been described earlier (Kästner, 1977, J. Soc. Cosmet. Chem. 28, 741; Klauder & Brill, 1947, Arch. Dermatol. 56, 197-215). So a decreasing irritancy can also be assumed for longer-chain chlorinated hydrocarbons, however, 2 -Chloro-2 -methylbutane must be considered to be a skin irritant as all tested short-chain brominated and chlorinated hydrocarbons.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the conditions of the test, all tested short-chain monobrominated and monochlorinated hydrocarbons have been shown to be irritant to the skin. Thus, it is exptrapolated that also tert-Amylchlorid (2 -Chloro-2 -methylbutane) is a skin irritant.