Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
This study dates from 1981 and was conducted in a jurisdiction where toxicity testing on cosmetic ingredients was legally required to be conducted on vertebrate animals.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
This study dates from 1981 and was conducted in a jurisdiction where toxicity testing on cosmetic ingredients was legally required to be conducted on vertebrate animals.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
not specified
GLP compliance:
no
Remarks:
The study was conducted in the USA in 1981, before the adoption of the OECD Principles of GLP in 1992.

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: two test sites per animal. Skin on one test site was abraded, and was left intact on the other test site.
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
Six (6) New Zealand white rabbits each received a single dermal application of 0.5 milliliter of the test article on two test sites, one abraded and one intact. The test sites were occluded for 214 hours and were observed individually for erythema, edema, and other effects 24 and 72 hours after application. Mean scores from the 214 and 72 hour. readings were averaged to determine the primary irritation index. The test article was used as received.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
1.48
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
This test article is not a primary dermal irritant to rabbits under conditions of this test.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The primary dermal irritation index score was determined to be 1.48 after 72 hours unde the conditions of the test.
Executive summary:

In this guideline equivalent study ( EPA OPP 81 -5) and prior to the adoption of OECD principles of GLP, the test material (EC 205-363-0) induced a primary dermal irritation score of 1.48. The study was conducted in 6 New Zealand White rabbits across the 24, 48, & 72 hour observation periods. The test material was exposed to the test animals (intact skin and abbraded skin, 24 hours) under occlusive conditions. The result of the test is not sufficient to meet the criteria for classification as a skin irritant under the criteria of the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).