Dimethyl maleate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline with restrictions (method shortly described; LD50 expressed in mL/kg instead of mg/kg; animals not fasted before exposure).

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

method shortly described; LD50 expressed in mL/kg instead of mg/kg; animals not fasted before exposure.

GLP compliance:

no

Remarks:

GLP was not mandatory at the time of the study

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): dimethyl maleate
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Germany.
- Weight at study initiation: 160-180 g.
- Housing: animal were housed in groups of 5 animals per cage.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Observation period: 14 days.

Doses:

Doses: 1.0, 1.5, 1.8, 2.0, and 3.1 mL/kg (1150, 1750, 2070, 2300, 3565 mg/kg bw).

No. of animals per sex per dose:

10

Control animals:

other: not necessary

Statistics:

The calculation of the LD50 was performed according to Fink and Hund, Arzneim.-Forsh 15, 1965, 624.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

1 909 mg/kg bw

95% CL:

1 644 - 2 116

Remarks on result:

other: rat

Mortality:

Mortality occurred at doses of 1750 mg/kg bw and higher concentrations.

Clinical signs:

other: Toxic symptoms: reduction of general conditions.

Any other information on results incl. tables

LD 50= 1.66 mL/kg. The density of dimethyl maleate is 1.15 g/cm³ at 20 °C. Therefore LD50 expressed in mg/kg is calculated to be 1909 mg/kg.

Table 1. Acute oral toxicity results

Dosis mg/kg b.w	Time of death	Toxicological Results Dead animals/ Aanimals with symptoms/Animals used
1150	-	0/0/10
1750	2 -5^d	3/10/10
2070	2 -7^d	7/10/10
2300	2 -4^d	8/10/10
3565	4^h -2^d	10/10/10

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based on the study results and according to EU classification criteria, the test substance is classified as Acute Tox. 4, according to the CLP regulation.

Executive summary:

Bayer (1977)

 

In an acute oral toxicity 10 non-fasted male rats were administered with 1150, 1750, 2070, 2300, 3565 mg/kg bw dimethyl maleate with a method similar to OECD guideline 401 with acceptable deviations (method shortly described; LD50 expressed in mL/kg instead of mg/kg; animals not fasted before exposure).

The animals were observed for 14 days after administration.

Mortality occurred at doses of 1750 mg/kg bw and higher concentrations. Reduction of general conditions was observed. The acute oral LD50 was calculated to be 1909 mg/kg bw.

Based on the study results and according to EU classification criteria, the test substance is classified as Acute Tox. 4, according to the EU-CLP regulation.