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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to to guideline study with acceptable restrictions (incomplete documentation, 20 h occlusive treatment, 2 animals)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(occlusive treatment, 20 h treatment duration, 2 animals)
Principles of method if other than guideline:
standardized internal test method (BASF test)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
-Source: Breeder
- Weight at study initiation: females: 3.21 and 3.22 kg

ENVIRONMENTAL CONDITIONS: not reported

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 50 % aqueous solution
Duration of treatment / exposure:
20 h
Observation period:
7 days
Number of animals:
2
Details on study design:
Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h exposition will serve as approximation.

TEST SITE
- Area of exposure: 2.5 x 2.5 cm (dorsal)

SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Other effects:
orange substance residues (lasting 20 hrs)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information