Registration Dossier
Registration Dossier
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EC number: 202-150-4 | CAS number: 92-36-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP. Over all well documented with minor deficiencies.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 4-(6-methylbenzothiazol-2-yl)aniline
- EC Number:
- 202-150-4
- EC Name:
- 4-(6-methylbenzothiazol-2-yl)aniline
- Cas Number:
- 92-36-4
- Molecular formula:
- C14H12N2S
- IUPAC Name:
- 4-(6-methyl-1,3-benzothiazol-2-yl)aniline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking &Churchill Ltd. Wyton
- Age at study initiation:
- Weight at study initiation: 96-144 (males), 99-144 (females)
- Housing: polypropylene cages with saw dust bedding, groups of five animals
- Diet (e.g. ad libitum): Rat and Mouse diet no. 1, special diet services ltd. Witham, Essex
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 48-68
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous methyl cellulose solution (1%)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Main study: 80-684 mg/ml / Range Finding: 80-400 mg/ml
MAXIMUM DOSE VOLUME APPLIED: 1.8 ml
DOSAGE PREPARATION (if unusual): - Doses:
- Range finding: 1000 / 5000 mg/kg
Main Study: 1000 / 1710 / 2924 / 5000 / 8550 mg/kg - 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: hourly for 5 hours following dosing and then daily. Individual bodyweghts recording at days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross macroscopic examination
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 6 350 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 4 961 - <= 8 128
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Best estimate
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5 650 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 3 693 - <= 8 645
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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