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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Test guideline
Guideline:
other: Dermal irritation: was assessed by the method prescribed in the Federal Register, 17 September 1964.
Principles of method if other than guideline:
Dermal irritation: was assessed by the method prescribed in the Federal Register, 17 September 1964.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the substance: Distilled Lanoline fatty acids
Lot number: 2-B
Date recieved: 30/03/1964

Test animals

Species:
rabbit
Strain:
other: Albino

Test system

Type of coverage:
not specified
Preparation of test site:
other: clipped free of fur
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5
Duration of treatment / exposure:
The animals were treated once and were observed daily for 7 days.
Observation period:
7 days
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
for Lanolic acids
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Remarks:
Lanolic acids
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: 72 hours
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
for Lanolic acids
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: 24 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Remarks:
Lanolic acids
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
erythema score
Remarks:
Lanesta L
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: 24 hours
Score:
0.83
Max. score:
4
Reversibility:
not fully reversible within: 24 hours
Irritation parameter:
erythema score
Remarks:
Lanesta S
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: 72 hours
Score:
0.67
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
Lanesta L
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: 24 hours
Score:
0.5
Max. score:
4
Reversibility:
not fully reversible within: 24 hours
Irritation parameter:
edema score
Remarks:
Lanesta L
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: 72 hours
Score:
0.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
for Lanesta S
Basis:
mean
Remarks:
for all 6 animals
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
erythema score
Remarks:
Lanesta S
Basis:
mean
Remarks:
for all 6 animals
Time point:
other: 72 hours
Score:
0.167
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
Lanesta S
Basis:
mean
Remarks:
for all 6 animals
Time point:
other: 24 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Remarks:
Lanesta S
Basis:
mean
Remarks:
for all 6 animals
Time point:
other: 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours

Any other information on results incl. tables

Lanolic Fatty Acids:

Slight to mild erythema and oedema were observed in both the intact and abraded sites at the 24 hour reading. The reactions ameliorated during the observation period and at 72 hours only slight erythema and oedema were observsd. The primary irritation index of 2.2, categorizes the material as "moderately irritant". However the substance has not been classified in terms of the Dangerous Substance Directive (DSD) or the Globally Harmonised System (GHS).

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, Lanolin fatty acids can not be considered to be a skin irritant.
Executive summary:

Based on the results of the study, Lanolin fatty acids can not be considered to be a skin irritant.