Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
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

Constituent 1
Chemical structure
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:
Signs of toxicity related to dose levels: Piloerection was observed in all animals during day one only. There were no other clinical sings.
Body weight:
Slightly low body weight gains were reported for 4 male rats on day 8. All other rats achived anticipated body weight gains throughout the study.
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.