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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed and documented in a robust manner (adopted from OECD SIDS; however, results are not reported in sufficient detail for classification)

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Unnamed
Year:
1986
Report Date:
1986
Reference Type:
publication
Title:
No information
Author:
PPG Ind. Inc.
Year:
1987
Bibliographic source:
TSCATS, OTS 0513463, Doc. I.D. 89-878000001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity of test material was not analytically confirmed. It was used as received from PPG Industries. Purity of that material is listed as > 98% on the MSDS.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Three female and three male New Zealand White rabbits were used.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Undiluted test material (0.5 ml) was placed on clipped skin under a gauze patch. Each patch was secured with a strip of non-irritating adhesive tape and the entire trunk of the animal was wrapped with a semi-permeable dressing. The dressings were removed 4 hours later and the skin was gently wiped with a moist cloth to remove as much residual material as possible.
Duration of treatment / exposure:
4 h
Observation period:
21 d
Number of animals:
6
Details on study design:
The animals were scored for erythema and eschar formation, edema formation and any other dermal effects or irritation at 1, 24, 48, and 72 hours and 4, 7, 10, 14, 17 and 21 days after removal of the dressings. The maximum score for each endpoint was 4 for each observation. All of the erythema and edema scores for each observation point were added together, and the sum was divided by the number of animals observed to determine an irritation score. The maximum irritation score was selected from the observation time yielding the highest irritation score.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: day 7
Score:
6.8
Max. score:
8
Reversibility:
not reversible
Remarks on result:
other: unspecified necrosis was observed in all animals at the end of the observation period. Only the time point with the highest mean score was reported.

Any other information on results incl. tables

Erythema and edema were present at each observation time through Day 21. The maximum irritation score of 6.8/8.0 was obtained at the Day 7 observation time. This score is consistent with a rating of "severe irritant". However, since necrosis was present on the test sites of all the animals, the test material was given a descriptive rating of "corrosive".
One male animal was found dead on Day 16 of the study.
The cause of death was not mentioned.

Applicant's summary and conclusion