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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Limited documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Primary Skin Irritation Test according to the Federal Hazardous Substances Act (FSHA)
Version / remarks:
not specified
Deviations:
not specified
GLP compliance:
no
Remarks:
Study prior to GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Supplier: not specified.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Monsanto, Pensacola Plant, Gonzalez FL
- Purity: Not reported

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
no details provided

Test system

Type of coverage:
not specified
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
168 hours
Number of animals:
6
Details on study design:
DETAILS OF TEST SITE:
- The test substance was applied to intact and abraded skin areas of the test animals

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
- Time after start of exposure: 24h

OBSERVATION TIME POINTS
- 4, 24, 48, 72 and 168h

SCORING SYSTEM:
- Method of calculation: Draize score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24h; 48h; 72h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24h; 48h; 72h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: not applicable
Score:
4.5
Max. score:
8
Reversibility:
fully reversible within: 7 days
Other effects:
- Other adverse local effects: Defatting Effect
- Skin sloughed off in seven to ten days. There was no injury in depth.

Any other information on results incl. tables

Hours

24

48

72

168

 Mean score (24 - 72 h)  

Animal No

Eryth.

Edema

Eryth.

Edema

Eryth.

Edema

Eryth.

Edema

 Eryth.  Edema

1

3

3

3

2

3

1

0

0

 3.0  2.0

2

3

3

3

2

3

1

0

0

 3.0  2.0

3

3

3

2

2

2

1

0

0

 2.3  2.0

4

3

2

3

2

3

2

0

0

 3.0  2.0

5

3

2

3

1

2

1

0

0

 2.7  1.3

6

2

1

2

1

3

1

0

0

 2.3  1.0

 

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
In this in vivo study on rabbits, the results indicate that the test item is a Skin Irritant (UN GHS: Category 2).
Executive summary:

This dermal irritation study was performed according to the method described in the FHSA (Federal Hazardous Substance Act). Six New Zealand Albino rabbits were dermally exposed to 0.5 mL of the test substance of unknown purity for 24 hours. The test substance was applied to shaved intact and abraded skin using occlusive coverage. Animals were observed for up to 7 days following exposure. The skin was scored at 24, 48, 72 and 168 hours after application. Mean Draize scores (mean of all animals, mean of 24 - 72 hour readings) for the intact skin were 2.7 for erythema (three animals with a score of 3.0, 1 animal with a score of 2.7 and 2 animals with a score of 2.3) and 1.7 (four animals with a score of 2.0, one animal with 1.3 and one with 1.0) for oedema. No irritation was found after 7 days (168 hours) and no injury in depth was found.