Dimethyl cyclohexane-1,4-dicarboxylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: older study (non GLP) with limited data and n=2

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1957

Report date:

1957

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

These studies were conducted using guinea pigs, and the same study was used to assess irritation and dermal toxicity. In this study,
two animals were used. Although the number of animals that were used was significantly less than current Guideline recommendations, the doses were much higher and the exposure (for the irritation assessment) was much longer than is currently utilized. Dose levels were 5 and 10 ml/kg. The backs of the guinea pigs were clipped and the material was applied to the entire back area under occlusion created by application ofa 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. Dermal toxicity and lethality were assessed by recording any clinical signs which subsequently evolved over a period of 1 0 days. As with the oral studies, weight loss was considered a sign of toxicity and an indication of absorption of the test chemical. The validity of these studies rests on the fact that, even though few animals were tested, the exposure regimen was far in excess of current guidelines. Current guidelines for a dermal irritation study specifiy a dose of 0.5 gram applied for 4 hours. Therefore, the exposure regimen in the Kodak studies described herein used doses up to 20 times more material applied six times longer. This resulted in an exposure 120 times more severe than currently required in skin irritation studies conducted using international Guidelines.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl cyclohexane-1,4-dicarboxylate

EC Number:

202-347-5

EC Name:

Dimethyl cyclohexane-1,4-dicarboxylate

Cas Number:

94-60-0

Molecular formula:

C10H16O4

IUPAC Name:

1,4-dimethyl cyclohexane-1,4-dicarboxylate

Test animals

Species:

guinea pig

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

5 and 10 mL/kg

Duration of treatment / exposure:

24 hours

Observation period:

10 days

Number of animals:

2

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

other: observation

Time point:

other: 24 hours

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

very slight edema at edge; no or slight redness

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The test substance, dimethyl 1,4-cyclohexanedicarboxylate, produced very slight skin irritation.

Executive summary:

The test substance, dimethyl 1,4-cyclohexanedicarboxylate (DMCD), was applied to the clipped back of 2 guinea pigs at concentrations of 5 and 10 mL/kg. Subsequently, the application site was occluded with a woven pad and a rubber dental dam for 24 hours. Following the application period, very slight edema was noted at the edge of the application site, which was accompanied by no or slight redness. Under the conditions of this study, DMCD was determined to be a very slight skin irritant.