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:
supporting study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Non-GLP study primary dermal irritation study in rabbits, limited information on test material, test system and study design.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Primary dermal irritation study in rabbits, limited information on test material, test system and study design.
GLP compliance:
not specified

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-42398681-AAA (T001589)
- Physical state: liquid
- Appearence: light brown
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
- Source: 3 New Zealand White rabbits, no further data on test animals available

Test system

Type of coverage:
not specified
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:
no data
Observation period:
72 hours
Number of animals:
3
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:
- Scoring of erythema and eschar formation: no erythema = 0; very slight erythema (barely perceptible) = 1; well-defined erythema = 2; moderate to severe erythema = 3; severe erythema (beet redness) to slight eschar formation (injuries in depth) = 4
- Scoring of edema formation: no edema = 0; very slight edema (edges of area well defined by definite raising) = 1; moderate edema (raise approximately 1 millimeter) = 3; severe edema (raised more than 1 millimeter and extending beyond the area of exposure) = 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
T1589 produced no dermal irritation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
For the evaluation of the primary irritation index scores of all rabbits were totaled at 24 h and 72 h giving an index of 0.00 (no dermal irritation).
From these data it is concluded that T001589, when given to New Zealand White rabbits at a single dose of 0.5 ml by dermal application produced no dermal irritation. Based on CLP regulation, the test item is not considered to be classified as skin irritant.