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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
08 - 12 Mar 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. Lack of study details and test substance was only applied at 75% dilution. No details on analytical purity of the substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
lack of study details; only 75% dilution of the test substance applied; no details on analytical purity of the substance
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Stearate de Glycerol
- Physical state: solid
- Analytical purity: no data
- Lot/batch No.: 1412F

Test animals

Species:
rabbit
Strain:
other: New Zealand
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.163 kg (mean)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: vaseline
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 75% (w/v) (5 g of the test substance was mixed with 3.2 mL vaseline to a final volume of 6.7 mL)
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated skin was cleaned with absorbent paper soaked with distilled water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
1 h post-application: slight erythema was observed in one animal. No edema and no further skin reactions were noted in any animal.
24-72 h post applicaion: no skin reactions were observed in any animal.
Other effects:
No further local or systemic effects were noted.

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