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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
Study period:
No data
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:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The skin irritation test included topical application of 0.1 ml of neat Dowfax 2A1 to the ear, and 0.5 ml to intact and abraded skin on the abdomen of a male New Zealand White (NZW) rabbit. The animal was bandaged for 24 hours after application of the test material to provide occlusion and prevent grooming of the application site. Twenty four hours after application the bandage was removed and the application sites were
graded. Five consecutive daily doses of Dowfax 2A1 were applied to the intact abdominal skin, and the apex of the left pinna, and three consecutive daily applications to the abraded abdominal site. Observations were recorded up to 72 hours after the final dose.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material: Dowfax 2A1
Source: Specialty Chemicals, The Dow Chemical Company
Properties: Amber liquid
pH= 7.0

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Male New Zealand White rabbit.

Test system

Type of coverage:
other: ear- open; intact and abraded abdomen- occluded
Preparation of test site:
other: shaved intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml- ear
0.5 ml- intact and abraded abdomen
Duration of treatment / exposure:
Five consecutive daily doses of Dowfax 2A1 were applied to the intact abdominal skin, and the apex of the left pinna, and three consecutive daily
applications to the abraded abdominal site.
Observation period:
Twenty four hours after application the bandage was removed and the application sites were graded. Observations were recorded out to 72 hours after the last dose.
Number of animals:
1
Details on study design:
The skin irritation test included topical application of 0.1 ml of neat Dowfax 2A1 to the ear, and 0.5 ml to intact and abraded skin on the abdomen of a male New Zealand White (NZW) rabbit. The abdomen of the rabbit was shaved with a straight razor at least three days prior to test initiation. The animal was bandaged for 24 hours after application of the test material to provide occlusion and prevent grooming of the application site. Twenty four hours after application the bandage was removed and the application sites were graded. Five consecutive daily doses of Dowfax 2A1 were applied to the intact abdominal skin, and the apex of the left pinna, and three consecutive daily applications to the abraded abdominal site. The study was terminated 72 hours after the final dose.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1d, 2d, 3d, 4d, 5d
Score:
1
Max. score:
6
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
ear/all timepoints/ Non-Draize test
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1d, 2d, 3d, 4d, 5d
Score:
1
Max. score:
6
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
ear/all timepoints/Non-Draize test
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1d, 2d, 3d, 4d
Score:
1
Max. score:
6
Reversibility:
not specified
Remarks on result:
not determinable
Remarks:
Intact abdomen/ Non-Draize test
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: day 5
Score:
2
Max. score:
6
Reversibility:
not specified
Remarks on result:
not determinable
Remarks:
Intact abdomen/Non-Draize test
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1d, 2d, 3d, 4d, 5d
Score:
1
Max. score:
6
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
abraded abdomen/ all timepoints/Non-Draize test
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: day 1
Score:
1
Max. score:
6
Reversibility:
not specified
Remarks on result:
not determinable
Remarks:
abraded abdomen/Non-Draize test
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 2d, 3d, 4d, 5d
Score:
2
Max. score:
6
Reversibility:
not specified
Remarks on result:
not determinable
Remarks:
abraded abdomen/Non-Draize test
Irritant / corrosive response data:
No irritation was observed on the ear. Very slight erythema was observed at the intact site after the last application. Very slight erythema was observed at the abraded site on test day two through test day five. The study was terminated 72 hours after the final dose.
Other effects:
The animal survived the test period. No clinical signs indicative of systemic toxicity were observed.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
No irritation was observed on the ear. Very slight erythema was observed at the intact site after the last application. Very slight erythema was observed at the abraded site on test day two through test day five. The study was terminated 72 hours after the final dose.
Executive summary:

A sample of Dowfax 2A1 was submitted by Specialty Chemicals, The Dow Chemical Company, Midland, MI for evaluation of acute oral and dermal toxicity and skin and eye irritation. This compound is a potential surfactant in cleaning solutions.

The skin irritation test included topical application of 0.1 ml of neat Dowfax 2A1 to the ear, and 0.5 ml to intact and abraded skin on the abdomen of a male New Zealand White (NZW) rabbit. Five consecutive daily doses of Dowfax 2A1 were applied to the intact abdominal skin, and the apex of the left pinna, and three consecutive daily applications to the abraded abdominal site. No irritation was observed on the ear. Very slight erythema was observed at the intact site after the last application. Very slight erythema was observed at the abraded site on test day two through test day five. The study was terminated 72 hours after the final dose. Based on the outcomes on the intact ear and abdomen rabbit skin, it was concluded that Dowfax 2A1 has only minimal skin irritation potential.