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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:
1971
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Limited report with only basic information on test substance purity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Hazardous Substances Act (FHSA) procedures
Principles of method if other than guideline:
Six instead of three animals were tested.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: mobile liquid
Details on test material:
- Name of test material (as cited in study report): Surfactant E-268 (anionic)
- Sample No. CHF 34-133
- Commercial name: Aerosol A-268

Test animals

Species:
rabbit
Strain:
not specified

Test system

Controls:
not specified
Amount / concentration applied:
0.5mL
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
SCORING SYSTEM: Draize et al, J. Pharmacol. exptl. therap., 82:377, 1944

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: effect on intact skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no erythema observed at 24 and 72 h
Remarks on result:
other: effect on intact skin
Remarks:
No observation reported at 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no erythema observed at 24 and 72 h
Remarks on result:
other: effect on intact skin
Remarks:
No observation reported at 48 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no erythema observed at 24 and 72 h
Remarks on result:
other: effect on intact skin
Remarks:
No observation reported at 48 h
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24/72 h mean
Score:
0
Max. score:
4
Reversibility:
other: no erythema observed at 24 and 72 h
Remarks on result:
other: effect on intact skin
Remarks:
No observation reported at 48 h
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24/72 h mean
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: effect on intact skin
Remarks:
No observation reported at 48 h
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24/72 h mean
Score:
0
Max. score:
4
Reversibility:
other: no erythema observed at 24 and 72 h
Remarks on result:
other: effect on intact skin
Remarks:
No observation reported at 48 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: effect on intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema observed at 24 and 72 h
Remarks on result:
other: effect on intact skin
Remarks:
No observation reported at 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema observed at 24 and 72 h
Remarks on result:
other: effect on intact skin
Remarks:
No observation reported at 48 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema observed at 24 and 72 h
Remarks on result:
other: effect on intact skin
Remarks:
No observation reported at 48 h
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema observed at 24 and 72 h
Remarks on result:
other: effect on intact skin
Remarks:
No observation reported at 48 h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema observed at 24 and 72 h
Remarks on result:
other: effect on intact skin
Remarks:
No observation reported at 48 h
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema observed at 24 and 72 h
Remarks on result:
other: effect on intact skin
Remarks:
No observation reported at 48 h
Irritant / corrosive response data:
The structure of the tissue at the site of contact was not destroyed or changed irreversibly.
Other effects:
No edema was noted on abraded skin. the erythema score (mean of 6 animals ) was 1 after 24 hours (3 rabbits with score 2) and 0.17 after 72 hours (1 animal with score 1).

Applicant's summary and conclusion

Conclusions:
In an in vivo skin irritation test performed with 0.5mL of an aqueous formulation with appr. 50% disodium isodecyl sulfosuccinate on intact and abraded skin, no irritation or corrosion was observed.