Registration Dossier

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
Study period:
June 6th, 1989 - June 27th, 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions Limited details on test substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Limited details on test substance
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Yellow, liquid

Test animals

Species:
rabbit
Strain:
other: Kleinrusse, Chbb:HM
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Thomae, Bieberach, Germany
- Age at study initiation: 5-6 months
- Weight at study initiation: mean: 2590 g
- Diet: Altromin 2023, ad libitum
- Water: ad libitum
- Acclimatisation: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 ml
Duration of treatment / exposure:
4 h
Observation period:
7 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²

SCORING SYSTEM:according to 84/449/EWG [Amtsblatt der Europäischen Gemeinschaft L 251/108]

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1168
Time point:
other: 24 h, 48 h and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No adverse effects observed
Irritation parameter:
erythema score
Basis:
animal: #1170
Time point:
other: 24 h, 48 h and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No adverse effects observed
Irritation parameter:
erythema score
Basis:
animal: #1175
Time point:
other: 24 h, 48 h and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all three animals
Time point:
other: 24 h, 48 h and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No adverse effects observed

Any other information on results incl. tables

Erythema score

Animal Number

1 h

1 day

2 days

3 days

7 days

1168

0

0

0

0

 0

1170

0

0

0

0

 0

1175

0

1

1

1

 0

 

Oedema Score

Animal Number

1 h

1 day

2 days

3 days

1168

0

0

0

0

1170

0

0

0

0

1175

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU