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Toxicological information

Acute Toxicity: oral

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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:
1984

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

Constituent 1
Chemical structure
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

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