Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
batch 1-83

Test animals

Species:
guinea pig
Strain:
not specified

Test system

Type of coverage:
other: rubber dam cuff
Preparation of test site:
not specified
Vehicle:
water
Controls:
no
Amount / concentration applied:
solid material moistened with water
Duration of treatment / exposure:
24 hours
Observation period:
2 weeks
Number of animals:
four (one @ 0.5g/kg b.w. and three @ 1.0 g/kg b.w.)
Details on study design:
Fur on the back of each guinea pig was clipped and the material was applied to the entire back area under occlusion created by application of a woven pad and a rubber dental dam over the application site. The material was left in contact with the skin for 24 hours, then washed off. Animals were assessed for skin irritation upon patch removal and for the next few days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 hours
Reversibility:
fully reversible
Remarks on result:
other: slight edema
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 hours
Reversibility:
fully reversible
Remarks on result:
other: slight edema
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 hours
Reversibility:
fully reversible
Remarks on result:
other: slight edema
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24 hours
Reversibility:
fully reversible
Remarks on result:
other: slight edema
Irritant / corrosive response data:
Slight edema was observed in 1 of 1 guinea pig treated with 0.5 g/kg and in 3 of 3 guinea pigs treated with 1.0 g/kg upon patch removal and for the following 24 hours.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Test material was determined to be a slight skin irritant
Executive summary:

The test article (1,4 cyclohexanedicarboxylic acid; CHDA) was applied to skin under occlusion at concentrations of 0.5 and 1.0 g/kg to one and three guinea pigs, respectively, for 24 hours. The test site was evaluated for evidence of skin irritation for 24 hours after removal of the occlusive dressing. Data indicate that all animals displayed slight edema at the test site. The test article was determined to be a slight skin irritant.