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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:
12 Jun 1991 - 15 Jun 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Analytical purity of test substance not specified, no experimental 48 h reading performed, 25 h exposure and occlusive dressing according to former guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
analytical purity of test substance not specified, no experimental 48 h reading performed, 25 h exposure and occlusive dressing according to former guideline.
Qualifier:
according to
Guideline:
other: FHSA (Federal Hazardous Substances Control Act), 16 CFR 1500.41
Deviations:
yes
Remarks:
25 instead of 24 h exposure.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: white powdered solid
- Analytical purity: no data
- Lot/batch No.: Lot #12051

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, NJ, USA
- Housing: individually in suspended stainless steel caging with mesh floors.
- Diet: pelleted, Purina Rabbit Chow , ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21




Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- concentration: undiluted and not moistened


Duration of treatment / exposure:
25 h
Observation period:
72 h
Reading time points: 25 and 72 h
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm² (see study report)
- Type of wrap if used: adhesive-backed gauze patches secured in place with an elastic wrapping.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently wiped clean of any residual test material
- Time after start of exposure: 25 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 25 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 25 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Intact skin:
No erythema or edema was observed in any animal during the study period.
Abraded skin:
After 25 h slight erythema formation was observed in 2/6 animals being fully reversible within 72 h.
No edema formation was observed in any animal during the study period.
Other effects:
All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified