Registration Dossier
Registration Dossier
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EC number: 201-379-7 | CAS number: 81-83-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (missing purity of the test substance)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
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:
- yes
Test material
- Reference substance name:
- Naphthalene-1,8-dicarboximide
- EC Number:
- 201-379-7
- EC Name:
- Naphthalene-1,8-dicarboximide
- Cas Number:
- 81-83-4
- Molecular formula:
- C12H7NO2
- IUPAC Name:
- 3-azatricyclo[7.3.1.0⁵,¹³]trideca-1(13),5,7,9,11-pentaene-2,4-dione
- Details on test material:
- - Name of test material (as cited in study report): Naphthalimid tr. (dry)
- Physical state: solid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, D
- Age at study initiation: 7 - 14 weeks
- Weight at study initiation: males 186 g, females 174 g
- Fasting period before study: 16 h
- Housing: in groups of 5 animals
- Diet: Altromin R 1324, Altromin GmbH, Lage, D, ad lib.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5°C
- Humidity (%): 60 +/- 5°C
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed several times on the day of exposure, twice daily on workdays and once daily on weekends and holidays; weighing was performed on days 0, 7 and 14
- Necropsy of survivors performed: yes, randomly
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no signs of toxicity observed
- Mortality:
- no mortality observed
- Clinical signs:
- other: no signs of toxicity observed
- Gross pathology:
- no noticeable effects reported
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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