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Registration Dossier
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EC number: 213-382-0 | CAS number: 941-69-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: In accordance with OECD 401 with non-GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N-phenylmaleimide
- EC Number:
- 213-382-0
- EC Name:
- N-phenylmaleimide
- Cas Number:
- 941-69-5
- Molecular formula:
- C10H7NO2
- IUPAC Name:
- 1-phenyl-2,5-dihydro-1H-pyrrole-2,5-dione
- Details on test material:
- purity: >99.9%
particle size: >355 um
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: arabic gum solution
- Doses:
- 284, 227, 182, 145, 116, 93, 74 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Statistics:
- Probit method of C.I.Bliss
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 128 - 148.3 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 114 - <= 165
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 128 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 148.3 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dose mortality (%)
ml/kg mg/kg male female
7.44 88.5 0 0
9.30 111 10 0
11.63 138 40 30
14.54 173 60 30
18.18 216 100 80
22.73 270 100 100
28.41 338 100 100 - Clinical signs:
- other: In group 182 mg/Kg or more, spontanious activity was markedly decreased and colonic respiration was observed from several minutes after administration. No marked changes were observed in surviving animals throughout the seven day observation period.
- Gross pathology:
- The liver of the dead animal in high dose groups were brownish-yellow Stomach showed diffused blood-spot In the mucous membrane.
There were no reportable macroscopic abnormalities in major organs in surviving animals.
Any other information on results incl. tables
The number of dead animals per day (total N=10)
ml/kg 1d. 2d. 3d. 4d. 5d. 6d. 7d. Dead No.
male 28.41 10 10
22.73 10 10
18.18 10 10
14.54 4 - 1 1 - - - 6
11.63 4 - - - - - - 4
9.30 1 - - - - - - 1
7.44 0 - - - - - - 0
female 28.41 10 10
22.73 10 10
18.18 7 1 - - - - - 8
14.54 3 - - - - - - 3
11.63 3 - - - - - - 3
9.30 0 - - - - - - 0
7.44 0 - - - - - - 0
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- LD50 = 128.0 mg/kg-male rat
LD50 = 148.3 mg/kg-female rat - Executive summary:
There are two studies on acute oral toxicitty using quite similar testing method, one is achieved at Y1984 using the submitter's sample and the other one is achieved at Y2000 under Japanese Govermental inspection program using another company's sample.
In an first acute oral toxicity study , groups of SD rats, 10/sex were given a single oral dose of PMI (provided by NIPPON SHOKUBAI on 1984.08.20) in arabic gum at doses of 0, 74.4 , 93.0, 116.3, 145.4, 181.8, 227.3, 284.1 mg/kg bw and observed for 7 days.
Oral LD50Males = 128 mg/kg bw (95% C.I. 114.8 - 141.3 mg/kg bw)
Females = 148.3 mg/kg bw (95% C.I. : 133.4 - 165.0 mg/kg bw)
The other study's results are;
LD50 for oral rat male = 153 mg/kg (95% C.I. 100 -237 mg/kg)
LD50 for oral rat female = 188 mg/kg (95% C.I. no data)
From a top level review, the first study has a lower K rating but is the most sensitive and gives lowest LD50.
The conclusion is that;
LD50 = 128.0 mg/kg-male rat
LD50 = 148.3 mg/kg-female rat
PMI is classified as the category 3 in accordance with GHS for acute oral toxicity based on the LD50.
No marked changes were observed in surviving animals throughout the seven day obsevation period.
There were no reportable macroscopic abnormalities in major organs in surving animals.
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