Registration Dossier

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
Study period:
2003-11-24 to 2003-12-13
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Comparable to OECD Guideline 404 study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Remarks:
This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study reports): T000836 (JNJ-16250351-AAH)
- Physical state: solid
- Appearance: white powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test material applied
Duration of treatment / exposure:
A single 4-hour semi-occluded application to the intact skin of 3 male rabbits; 3 minute and 1-hour semi-occluded application to the intact skin of 1 male rabbit.
Observation period:
at 1, 24, 48, and 72 h intervals after administration
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data


SCORING SYSTEM:
Draize Scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
mean
Basis:
animal: 11
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Remarks:
mean
Basis:
animal: 147
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
mean
Basis:
animal: 148
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
mean
Basis:
animal: 11
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
not applicable
Irritation parameter:
edema score
Remarks:
mean
Basis:
animal: 147
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
not applicable
Irritation parameter:
edema score
Remarks:
mean
Basis:
animal: 148
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
not applicable
Irritant / corrosive response data:
The test substance caused mild erythema at 24 and 48 h at 2 skin sites. The erythema had reversed by the 72 h observation. No edema was evident at any time at any skin site. No response was noted in the rabbit treated for 3 minutes and 1 hour.

Any other information on results incl. tables

Expert report (issued 2015 -04 -29 by data-owner):

The expert report provides an expert judgement of T000836 of study SPL 1827/115.

The expert conclusion stated: Three animals were observed for skin irritation after a dermal application of the test substance.  For each of the three test animals the average scores for three consecutive days (usually 24, 48 and 72 hours) were calculated separately for oedema and erythema.  Due to the fact that the cut-of value defined in the criteria of the GHS regulation (i.e. 1.5) was not reached for at least two animals out of three, the test item is not considered as a skin irritant according to the new guidelines. For this reason it was decided not to classify the compound as a skin irritant.

Reason for expert report: criteria for classification changed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was found to be mildly irritating to rabbit skin. However, based on the criteria of the CLP Regulation, the test item should not be classified for skin irritation as reversible effects are observed and the scores for erythema and edema of the three animals were below the cut-off value of 2.3.