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Diss Factsheets

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Primary Irritation to the skin is measured by a patch-test technique on the abraded and intact skin of the rabbits, clipped free of hair. The six rabbits are used in abraded and intact skin tests. (5 assessed one died).
Single 24-hour application to two sites each on the intact skin of 5 rabbits. After 24 hours exposure, the patches are removed and the resulting reactions are evaluated on the basis of the designated values.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C16-18
EC Number:
267-008-6
EC Name:
Alcohols, C16-18
Cas Number:
67762-27-0
Molecular formula:
C16 H34 O
IUPAC Name:
Alcohols, C16-18
Details on test material:
- Name of test material (as cited in study report):Tradename Epal 1618 linearity unstated (probably linear)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
-rabbit
- Strain: New Zealand White
- Sex: Not reported
- Source: Not reported
- Age: Not reported
- Weight at study initiation: Not reported
- Number of animals: 6 (5 assessed one died)
- Controls: No

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact and abraded
Vehicle:
other: Peanut oil
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 (5 assessed one died)
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: 50% in peanut oil
- Area of exposure: Not reported
- Occlusion: semi-occlusive
- Vehicle: Peanut oil
- Concentration in vehicle: 50%
- Exposure period: 24 hours
- Total volume applied: 0.5 ml
- Postexposure period: 72 hours
- Removal of test substance: Not reported

EXAMINATIONS
- Scoring system: Draize
- Examination time points: 24 and 72 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6
Time point:
24 h
Score:
0.5
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6
Time point:
24 h
Score:
0.5
Reversibility:
fully reversible within: 72 hourS
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6
Time point:
24 h
Score:
0.5
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6
Time point:
24 h
Score:
1.5
Reversibility:
fully reversible within: hours post
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6
Time point:
24/48/72 h
Score:
0.7
Reversibility:
other: By 72 hours post exposure erythema scores in 4 of the 5 surviving rabbits were 0, in the 5th rabbit the erythema score had reduced from 2 to 1.
Remarks on result:
other: intact skin .
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6
Time point:
72 h
Score:
0.5
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6
Time point:
72 h
Score:
1.5
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6
Time point:
24/48/72 h
Score:
0.8
Reversibility:
other: y 72 hours post exposure erythema scores in 4 of the 5 surviving rabbits were 0, in the 5th rabbit the erythema score had reduced from 2 to 1.
Remarks on result:
other: abraded skin
Irritation parameter:
other: Oedema
Basis:
mean
Remarks:
6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Following a 24 hour semi-occlusive exposure to rabbit skin Alcohols, C16-18 is classified as non-irritant based on either EU or GHS criteria.
The alcohols with chain lengths of C16-18 are non-irritant to skin.
Executive summary:

Following a 24 hour semi-occlusive exposure to rabbit skin Alcohols, C16-18 is classified as non-irritant based on either EU or GHS criteria. The alcohols with chain lengths of C16-18 are non-irritant to skin.