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EC number: 412-570-1 | CAS number: 119462-56-5 PERKALINK 900
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:
- 1 990
- 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
- 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
Constituent 1
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.
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