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:
2003-07-07 to 2004-09-22
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);

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Remarks:
Study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme. No formal claim of GLP compliance was 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-1806792-AAA (T001325)
- Physical state: solid (powder)
- Appearance: brown powder
Specific details on test material used for the study:
no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (deg C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: From: 2003-07-07 To: 2003-07-10

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): not applicable
Duration of treatment / exposure:
A single 4 hour treatment
Observation period:
1, 24, 48, and 72 hours
Number of animals:
three male rabbits
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:
Animals were scored on erythema/eschar and oedema formation.
Primary Irritation Index was assigned as follows:
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:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
8
Reversibility:
other: Non-irritating so not applicable
Remarks on result:
other: Non-irritant
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 93
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: male
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 94
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: male
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 96
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: male
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 93
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: male
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 94
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: male
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 96
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: male
Irritant / corrosive response data:
Non-irritant
Other effects:
Light brown-coloured staining was reported for all (3) test animals.

Any other information on results incl. tables

Skin Reaction

Observation Time

Rabbit 1

Rabbit 2

Rabbit 3

Total

Erythema/ Eschar Formation

1 Hour

0 STA

0 STA

0 STA

( 0 )

24 Hours

0 STA

0 STA

0 STA

0

48 Hours

0 STA

0 STA

0 STA

( 0 )

72 Hours

0 STA

0 STA

0 STA

0

Total

0

0

0

0

Mean Score

0.0

0.0

0.0

0.0

Oedema Formation

1 Hour

0

0

0

( 0 )

24 Hours

0

0

0

0

48 Hours

0

0

0

( 0 )

72 Hours

0

0

0

0

Total

0

0

0

0

Mean Score

0.0

0.0

0.0

0.0

Sum of 24 and 72 Hour Readings (s)

0

Primary Irritation Index (S/6) and Classification

0/6 = 0.0
NON-IRRITANT

 

STA = Light brown-coloured staining

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

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was found to have a score of 0 for erythema/eschar formation and oedema formation at 1, 24, 48, and 72 hours. The substance was found not to be irritating. The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC.