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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
; purity not reported
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
; purity not reported
GLP compliance:
no
Remarks:
test was performed prior to GLP-requirement

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: White Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld
- Age at study initiation: 4-6 months
- Weight at study initiation: 1.95-2.2 kg
- Housing: individually stainless steel cage type Asta
- Diet: ssniff, no further data
- Water: ad libitum
- Acclimation period: 1 day, in-house breeding


ENVIRONMENTAL CONDITIONS according to guideline

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: control patches without test substance
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted, 30°C warm to reduce viscosity

Duration of treatment / exposure:
4 h
Observation period:
1 h, 24h, 48 h and 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal between shoulder and sacral region
- % coverage: 4 patches 6.25 cm² / patch
- Type of wrap if used: Acrylastic



SCORING SYSTEM: according to guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
no findings

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Classification: not irritating