4-(6-methylbenzothiazol-2-yl)aniline

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

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

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

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

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

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

6 350 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Literature report, well documented. No informations about GLP or Guideline followed.

Guideline:

other: no information

Principles of method if other than guideline:

see literature article for details

GLP compliance:

not specified

Test type:

acute toxic class method

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Sex:

male

Dose descriptor:

LCLo

Effect level:

3 mg/L air

Interpretation of results:

moderately toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The vapours of the substance condensed to small particles of median diameter of 5 µm. The substance is moderatly toxic. A precautionary classification as acut tox 4 is justified.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating conc.

Value:

3 000 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Guideline:

other: no data

Principles of method if other than guideline:

No details on method. Result reported in publication.

GLP compliance:

not specified

Test type:

other: no data

Species:

rabbit

Strain:

not specified

Sex:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 7 500 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

17 000 mg/kg bw

Justification for classification or non-classification

There are reliable studies on the toxicity on oral route. No adverse effect was observed below relevant levels for classification.

There are literature citations available, which indicate a very low dermal toxicity, which also is not relevant for classification.

The dust of the substance is obviously moderatly toxic.