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:
2005-01-18 to 2005-01-21
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Study was conducted according 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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no
Remarks:
The 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:
liquid
Details on test material:
- Name of test material (as cited in study reports): JNJ-7928531-AAA (T001481)
- Physical state: liquid
- Appearance: Colourless, light yellow to brown liquid

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:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): no data
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE: no data

REMOVAL OF TEST SUBSTANCE: no data

OBSERVATION TIME POINTS:
- Skin reactions were observed 1, 24, 48, and 72 hours after administration.

SCORING SYSTEM:
- According to Draize
- Primary Irritation Index
0 = Non-irritant
>0 - 2 = Mild irritant
>2 - 5 = Moderate irritant
>5 - 8 = Severe irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema was noted at two treated skin sites at the 24 and 48-hour observations. One treated skin site appeared normal throughout the study and the remaining treated skin sites appeared normal at the 72-hour observation.

Any other information on results incl. tables

Table 1. Individual Skin Reactions Following 4-Hour Exposure Period

Skin Reaction

Observation Time

Individual Scores – Rabbit Number and Sex

Total

63 Male

64 Male

65 Male

Erythema/Eschar Formation

1 Hour

0

0

0

(0)

24 Hour

1

1

0

2

48 Hour

1

1

0

(2)

72 Hour

0

0

0

0

Oedema Formation

1 Hour

0

0

0

(0)

24 Hour

0

0

0

0

48 Hour

0

0

0

(0)

72 Hour

0

0

0

0

Sum of 24 and 72 Hour Readings

2

Primary Irritation Index (S/6) and Classification

2/6=0.3

Mild Irritant

( ) = Total values not used for calculation of primary irritation index

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The Primary Irritation Index was 0.3 in the study, therefore, the test item was considered to be a mild irritant to rabbit skin. However, the test item should not be classified as the mean score for all animals is below the cut off value of 2.3.