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:
2004-02-03 to 2004-02-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study performed similar to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion); however, the test substance is not adequately characterized and insufficient information is provided on the test animals, testing methodology and results for a thorough assessment of reliability.

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:
yes
Remarks:
Inadequate documentation of test material, test animals, environmental conditions, methodology and results.
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Inadequate documentation of test material, test animals, environmental conditions, methodology and results.
GLP compliance:
no
Remarks:
The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLPmonitoring 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 report): JNJ-1580774-AAA (T000835)
- Physical state: solid powder
- Appearance: slight beige
Specific details on test material used for the study:
no data

Test animals

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


ENVIRONMENTAL CONDITIONS: no data

Test system

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

REMOVAL OF TEST SUBSTANCE: no data

SCORING SYSTEM:
according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Irritant / corrosive response data:
Very slight erythema was noted at all treated skin sites at the 1, 24 and 48-hour observations.Very slight oedema was noted at one treated skin site at 24-hour observation. All treated skin sites appeared normal at the 72-hour observation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was found to be mildly irritating to rabbit skin. However, based on the criteria of the CLP Regulation, the substance 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.