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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:
weight of evidence
Study period:
1983
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The Skin test was carried out as a patch test.
The chosen test site was inside of the forearm and the chosen test plasters were numbers 1000 and 1500 from the Beiersdorf Company, Hamburg.
The preparation to be tested was introduced at 50% diluted in olive oil (approx 1,0g) into the chamber of the plaster; this was fixed to the skin and removed after approx. 24 hours for assessment of the result.
The following observations were made in this assessment: Marking of the individual test sites - observation and evaluation, exclusion of reflex erythema.
The assessment was repeated after 24 hours on each subject.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Fatty acids, safflower-oil, Et esters
EC Number:
293-106-3
EC Name:
Fatty acids, safflower-oil, Et esters
Cas Number:
91051-53-5
IUPAC Name:
Fatty acids, safflower-oil, Et esters
Test material form:
liquid
Specific details on test material used for the study:
Safester A 75, 50% in Olive oil
Batch: 211088

Test animals

Species:
other: Humans
Details on test animals or test system and environmental conditions:
50 subjects, comprising both women and men, were tested; all were in the age group between 16 and 60.
The skin region examined was the inside of the forearm in all cases.

Test system

Amount / concentration applied:
1g
Duration of treatment / exposure:
24h
Observation period:
48h
Number of animals:
50 subjects (women & men)
Details on study design:
The Skin test was carried out as patch test.
The chosen test site was inside of the forearm and the chosen test plasters were numbers 1000 and 1500 from the Beiersdorf Company, Hamburg.
The preparation to be tested was introduced undiluted (approx 1,0g) into the chamber of the plaster; this was fixed to the skin and removed after approx. 24 hours for assessment of the result.
The following observations were made in this assessment: Marking of the individual test sites - observation and evaluation, exclusion of reflex erythema.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: erythema dubiosum, erythema; erythema papulovesicularis; erythema papulovesicularis gravis; bulla, erosio, ulcus
Basis:
other: 54 persons
Time point:
24 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
other: 54 persons
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: N/A
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
other: 54 persons
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: N/A
Remarks on result:
no indication of irritation
Irritation parameter:
other: erythema dubiosum, erythema, erythema paulovesicularis; erythema
Basis:
other: 54 persons
Time point:
48 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
other: 54 persons
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: N/A
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
other: 54 persons
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: N/A
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
other: 54 persons
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
other: 54 persons
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
other: erythema dubiosum, erythema, erythema paulovesicularis; erythema
Basis:
other: 54 persons
Time point:
72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
In this skin test, 54 subjects of different skin types and different degrees of sensitivity were examined. A third of the subjects had very sensitive skin prone to dermatosis and eczema.
The preparation (SAFESTER A 75, 50% in Olive oil) examined showed no reaction.
This preparation has an excellent skin tolerance.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
SAFESTER A 75 shows excellent skin compatibility and was shown to be non-irritating to the skin of human volunteers.
Executive summary:

SAFESTER A 75 shows excellent skin compatibility and was shown to be non-irritating to the skin of human volunteers.