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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
November 18th 1980 to December the 12th 1980
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The study is not suitable for classification as the exposure conditions presenting a worst-case scenario (24 h exposure period; occlusive dressing).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: The procedure followed was a modification of that described by J.H. Draize
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Lanolin alcohols
IUPAC Name:
Lanolin alcohols

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: not stated
- Age at study initiation: about 3 months
- Weight at study initiation: 2 kg
- Housing: housed in galvanised or stainless steel cages
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: Animals were acclimitised at least 4 days prior to test initiation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not stated
- Humidity (%): not stated
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 hours light followed by 12 hours darkness

IN-LIFE DATES: From Day 0 To: End of study

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
other: mineral oil
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution): 0.5 ml of test article

Duration of treatment / exposure:
single application, 24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5cm
- % coverage: not stated in report
- Type of wrap if used: surgical gauze pad

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: 24 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 24 hours
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
for all 6 animals
Time point:
other: 24 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 24 hours
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
for all 6 animals
Time point:
other: 24 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 24 hours
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
for all 6 animals
Time point:
other: 24 hours
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 24 hours
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
for all 6 animals
Time point:
other: 72 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
for all 6 animals
Time point:
other: 72 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
for all 6 animals
Time point:
other: 72 hours
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
for all 6 animals
Time point:
other: 72 hours
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The study is not suitable for classification as the exposure conditions presenting a worst-case scenario (24 h exposure period; occlusive dressing).