Dimethyl maleate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study with restrictions (analytical purity not reported; occlusive dressing instead of porous dressing).

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

analytical purity not reported, occlusive dressing instead of porous dressing.

Principles of method if other than guideline:

This study was conducted using the method of Noaks and Sanderson (1969). British Journal of Industrial Medicine 26:59-64.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl maleate

EC Number:

210-848-5

EC Name:

Dimethyl maleate

Cas Number:

624-48-6

Molecular formula:

C6H8O4

IUPAC Name:

dimethyl (Z)-but-2-enedioate

Details on test material:

- Name of test material (as cited in study report): Maleic acid dimethylester
- Analytical purity: not reported
- Physical state: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Age at study initiation: 9-12 weeks old.
- Weight at study initiation: 235-288 g (males); 179-230 g (female).

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

5/rats/sex/group received a single application of 500 or 2000 mg MAD/kg body weight on their shaved backs (area approx. 20 cm²), and this was covered with an occlusive dressing for 24 hours. The rats were observed for 14 days after application, and systemic and local effects were recorded.

Duration of exposure:

24 hours

Doses:

500 or 2000 mg of dimethyl maleate/kg body weight.

No. of animals per sex per dose:

5/sex/ group

Control animals:

no

Details on study design:

Details on study design
- Duration of observation period following administration: 14 days.
- Examinations performed: systemic and local effects were recorded.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: rat

Mortality:

No deaths occurred after application of 500 or 2000 mg dimethyl maleate/kg body weight.

Clinical signs:

other: No systemic effects occurred after application of 500 or 2000 mg dimethyl maleate/kg body weight. Local erythema followed by necrosis could be observed in the treated skin in both groups.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

Heimann (1991)

Acute dermal toxicity study was conducted according to OECD guideline 402 with acceptable restrictions (analytical purity not reported, occlusive dressing instead of porous dressing).

5 rats/sex/group received a single application of 500 or 2000 mg dimethyl maleate/kg body weight on their shaved backs (area approx. 20 cm²), and this was covered with an occlusive dressing for 24 hours. The rats were observed for 14 days after application, and systemic and local effects were recorded.

No deaths and no systemic effects occurred after application of 500 or 2000 mg dimethyl maleate/kg body weight. Therefore, the LD50 was concluded to be greater than 2000 mg/dimethyl maleate body weight. Local erythema and followed by necrosis could be observed on the treated skin in both groups.

Based on the study results and according to EU and EU-CLP classification criteria, the test substance is not to be classified.