1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well conducted study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

A group of ten rats (5 males and 5 females) was treated at 2000 mg/kg bw. Animals were examined for mortality, clinical signs, body weight and a terminal autopsy was conducted.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene

EC Number:

412-570-1

EC Name:

1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene

Cas Number:

119462-56-5

Molecular formula:

Hill formula: C18 H16 N2 O4

IUPAC Name:

3-methyl-1-({3-[(3-methyl-2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)methyl]phenyl}methyl)-2,5-dihydro-1H-pyrrole-2,5-dione

Details on test material:

- Name of test material (as cited in study report): m-xylylene bis(citraconimide)
Batch no: BOM pp2
Purity: 87 ± 3% (m/m); see CoA (attached)
Other: M-xylylene bis (itaconimide): 2-5%
appearance: brown powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

20% w/v in corn oil
10.0 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female rats.

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: Piloerection was observed in all animals during day one only. There were no other clinical sings.

Gross pathology:

Effects on organs: None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Oral LD50 rat > 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test item was evaluated in a GLP-compliant study on male and female Sprague-Dawley rats. The acute oral LD50 was determined with > 2000 mg/kg bw. As clinical sign piloerection was observed on the day of treatment only.