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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The skin irritation test included topical application of the material to intact and abraded skin on the abdomen of two male New Zealand White
rabbits. Both application sites on one rabbit were moistened with 0.5 ml of water, while the material was applied under dry conditions on the
other rabbit. The rabbits received either three (abraded sites) or five (intact sites) daily 0.5 g applications. The animals were on study for
eight days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate]
EC Number:
915-640-4
Molecular formula:
C22 H30 O7 S2 . 2 Na
IUPAC Name:
Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate]
Details on test material:
Chemical Name : XU-40340.00. DOWFAX 3B2, Powder Form
Appearance: tan solid
Source: Specialty Chemicals Technical Services & Development Department, The Dow Chemical Company

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Two male rabbits were used for the skin irritation test.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact and abraded
Vehicle:
other: unchanged and moistened
Controls:
no
Amount / concentration applied:
0.5 g,
Both application sites on one rabbit were moistened with 0.5 ml of water, while the material was applied under dry conditions on the
other rabbit.
Duration of treatment / exposure:
The rabbits received either three (abraded sites) or five (intact sites) daily 0.5 g applications. The test material was left in place for 24 hours.
Observation period:
8 days
Number of animals:
2
Details on study design:
The skin irritation test included topical application of the material to intact and abraded skin on the abdomen of two male New Zealand White
rabbits. Both application sites on one rabbit were moistened with 0.5 ml of water, while the material was applied under dry conditions on the
other rabbit. The rabbits received either three (abraded sites) or five (intact sites) daily 0.5 g applications. The test material was applied under a cotton pad and held in place with a cloth bandage. The test material was left in place for 24 hours. The animals were on study for eight days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72, 96 hours and 8 days
Score:
1
Max. score:
6
Reversibility:
other: not applicable
Remarks on result:
other: Intact abdomen- dry patch
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 and 96 h and 8 days
Score:
1
Max. score:
6
Reversibility:
other: not applicable
Remarks on result:
other: Intact abdomen- dry patch
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h
Score:
3
Max. score:
6
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Abraded abdomen- dry patch; Cotton glued on skin, erythema may be due to mechanical injury.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 48 and 72 h
Score:
4
Max. score:
6
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Abraded abdomen- dry patch
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 96 h
Score:
3
Max. score:
6
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Abraded abdomen- dry patch
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 8 days
Score:
1
Max. score:
6
Reversibility:
other: not applicable
Remarks on result:
other: Abraded abdomen- dry patch
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 and 96 h and 8 days
Score:
1
Max. score:
6
Reversibility:
other: not applicable
Remarks on result:
other: Abraded abdomen- dry patch
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h
Score:
3
Max. score:
6
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Intact abdomen- wet patch; Cotton glued on skin, erythema may be due to mechanical injury.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 48 h
Score:
4
Max. score:
6
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Intact abdomen- wet patch; Cotton glued on skin, erythema may be due to mechanical injury.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 72 and 96 h
Score:
3
Max. score:
6
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Intact abdomen- wet patch; Cotton glued on skin, erythema may be due to mechanical injury.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 8 days
Score:
1
Max. score:
6
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72, and 96 h and 8 days
Score:
1
Max. score:
6
Reversibility:
other: not applicable
Remarks on result:
other: Intact abdomen- wet patch
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h
Score:
3
Max. score:
6
Reversibility:
fully reversible within: 96 h
Remarks on result:
other: Abraded abdomen- wet patch; Cotton glued on skin, erythema may be due to mechanical injury.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 48 h
Score:
4
Max. score:
6
Reversibility:
fully reversible within: 96 h
Remarks on result:
other: Abraded abdomen- wet patch; Cotton glued on skin, erythema may be due to mechanical injury.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 72 h
Score:
3
Max. score:
6
Reversibility:
fully reversible within: 96 h
Remarks on result:
other: Abraded abdomen- wet patch; Cotton glued on skin, erythema may be due to mechanical injury.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 96 h and 8 days
Score:
1
Max. score:
6
Reversibility:
other: not applicable
Remarks on result:
other: Abraded abdomen- wet patch
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 and 96 h and 8 days
Score:
1
Max. score:
6
Reversibility:
other: not applicable
Remarks on result:
other: Abraded abdomen- wet patch
Irritant / corrosive response data:
No irritation was observed when the test material was administered unmoistened (dry patch) to intact skin after prolonged and repeated contact. Slight to moderate erythema was observed after prolonged and repeated contact under moistened conditions (wet patch) and on the abraded site under unmoistened (dry patch)conditions. The dermal response was attributed to mechanical injury. The test material appeared to glue the cotton patch to the skin when moisture was present and removal of the patch was difficult. Results of the skin irritation test indicated the test material is unlikely to be absorbed in acutely toxic amounts.
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
other: Not categorized, irritation was a result of mechanical injury
Remarks:
Criteria used for interpretation of results: other: EU GHS
Conclusions:
No irritation was observed when the test material was administered unmoistened (dry patch) to intact skin after prolonged and repeated contact. Slight to moderate erythema was observed after prolonged and repeated contact under moistened conditions (wet patch) and on the abraded site under unmoistened (dry patch)conditions. The dermal response was attributed to mechanical injury. The test material appeared to glue the cotton patch to the skin when moisture was present and removal of the patch was difficult. Results of the skin irritation test indicated the test material is unlikely to be absorbed in acutely toxic amounts.
Executive summary:

The test material, XU-40340.00 DOWFAX 3B2, powder form, was submitted by the Specialty Chemicals Technical Services & Development Department, The Dow Chemical Company, Midland, MI. The material is of interest for use in the agriculture, cleaning, and textile industries. Standard acute toxicologic tests were conducted and included the acute oral toxicity, skin irritation, and eye irritation studies.

Topical application of the test material to the skin of a New Zealand White rabbit, under dry conditions, resulted in no irritation after prolonged and repeated contact. Slight to moderate- erythema was observed under moistened conditions after prolonged and repeated contact. The dermal response was attributed to mechanical injury. The test material appeared to glue the cotton patch to the skin when moisture was present and removal of the patch was difficult.