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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
Study period:
1985-10-01 to 1985-10-25
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:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
This study follows the guidelines published in the Federal Register Vol. 43 No. 163 Part IV, EPA July 26, 1979.
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-118872-AAA (T000749)
- Physical state: liquid
- Appearance: Light yellow, light brown liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
Albino
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Laboratory in-house stock colony
- Age at study initiation: No data
- Weight at study initiation: 4.35 - 4.45 kg
- Housing: Housed in a wire cage in compliance with AALAC regulations.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS: no data


IN-LIFE DATES: No data

Test system

Type of coverage:
open
Preparation of test site:
other: intact or abraded
Vehicle:
not specified
Controls:
other: the back of the rabbits with intact skin
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted

VEHICLE: no data
Duration of treatment / exposure:
Single dose for 6 hour exposure
Observation period:
after 24 hours, 2, 3, 4, 5, 6, 7, 10 and 14 days, etc. until reactions proved to be reversible.
Number of animals:
Two males
Details on study design:
TEST SITE
- Area of exposure: The skin at the right side of the back was abraded, whereas the left side was left intact. A definite sample was applied for each side to an area of 1" x 1" skin square on the intact and on the abraded skin.
- % coverage: No data
- Type of wrap if used: Not applicable.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The materials were flushed and washed with handwarm water and gently dried.
- Time after start of exposure: after 6 hours


SCORING SYSTEM:
The reactions were evaluated in both the group with intact skin and the group with abraded skin after 24 hours, 2, 3, 4, 5, 6, 7, 10 and 14 days, etc. until reactions proved to be reversible. The Primary Irritation Index (PII) and Classification was according to Draize and evaluated after 24 and 72 hours of application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: Intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
not fully reversible within: 13 days (score 1 on days 7, 10 and 13)
Remarks on result:
other: Intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: Intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: Intact skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: abraded skiin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
T 749 resulted in a slight irritation to the skin of the rabbits.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the conditions of this study, the test item resulted in a slight irritation to the skin of the rabbits. Based on the results of this study and the criteria of the CLP Regulation, the substance is classified as irritating to the skin based on persisting inflammation observed until day 14 which is reflected in the scoring of erythema and edema until day 14.