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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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).