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:
2004-11-04 to 2004-11-12
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Study is 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.

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:
: Insufficient information on the test substance and test animals.
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: Insufficient information on the test substance and test animals.
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:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study reports): JNJ-4754724-AAA (T002488)
- Physical state: solid
- Appearance: light brown powder
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:
- 3 male New Zealand White rabbits, no further data

ENVIRONMENTAL CONDITIONS: no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact
Vehicle:
not specified
Controls:
other: Untreated skin areas of the test animals served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): no data
Duration of treatment / exposure:
Method 1: 4 hours
Method 2: 3 minutes and 1 hour
Observation period:
Method 1: 72 hours
Method 2: 72 hours
Number of animals:
Method 1: 3
Method 2: 1
Details on study design:
TEST SITE: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- Skin reactions were recorded 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:
mean
Remarks:
following 4-hour exposure
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: A score of 0 was obtained for the three rabbits.
Irritation parameter:
edema score
Basis:
mean
Remarks:
following 4-hour exposure
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: A score of 0 was obtained for the three rabbits.
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
following 3-minute exposure
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not aplicable
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
following 3-minute exposure
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
following 1-hour exposure
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No evidence of skin irritation was noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was found to be a non-irritant with a primary irritation index of 0.0.