Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: Non GLP Study, but well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water

Results and discussion

Any other information on results incl. tables

No dermal irritation was observed in three rabbits throughout the study. The remaining three

rabbits exhibited slight or mild erythema at one hour after test substance removal. One rabbit

also exhibited slight edema. At 24 hours, slight or mild erythema was observed in two rabbits,

and no dermal irritation was observed in four rabbits. No dermal irritation was observed at 48 or

72 hours. No clinical signs were observed, and no body weight loss occurred during the study.

A summary of skin responses is presented in the following table.

SUMMARY OF SKIN RESPONSES HOURS AFTER TEST SUBSTANCE REMOVAL

ERYTHEMA EDEMA

RESPONSE 1 24 48 72 1 24 48 72

No Response 3/6 4/6 6/6 6/6 5/6 6/6 6/6 6/6

Slight 1/6 1/6 0/6 0/6 1/6 0/6 0/6 0/6

Mild 2/6 1/6 0/6 0/6 0/6 0/6 0/6 0/6

Moderate 0/6 0/6 0/6 0/6 0/6 0/6 0/6 0/6

Severe 0/6 0/6 0/6 0/6 0/6 0/6 0/6 0/6

Under the conditions of this study, the test item was a mild skin irritant.

If these test scores are to be used for EEC/OECD classification, according to the guide to the

labeling of dangerous substances published in the Official Journal of European Communities

(67/548/EEC), the test item probably should not be classified as irritant unless additional data proves

otherwise.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU