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
Study period:
1987-04-07 to 1987-04-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Chbb-SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.0 - 2.1 kg
- Housing: Stainless steel cages, one animal per cage
- Diet: Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 °C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15 times
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 cm3
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours and 7, 8, 10 and 14 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6 cm2 skin area
- Type of wrap: cotton wool rolls and polyethylenfilm

REMOVAL OF TEST SUBSTANCE
- Washing: warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: According to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 h
Score:
0.6
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 h
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
The test item showed skin irritating effects. According to CLP criteria a classification is not necessary.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS