Reaction mass of methyl 2-methylbenzene-1-sulfonate and methyl toluene-4-sulphonate

Endpoint summary

Description of key information

An acute oral toxicity study in female rats is available for the substance. In this study 500, 1000, 2000 and 4000 mg/kg bw of the undiluted test material was administered by gavage to 5 rats/dose group.

All applied doses were fatal for the animals within 1- 4 days following treatment. In the low dose group 3/5 survived. Balance problems was the only clinical effect observed in all treated animals. Body weights/body weight development was not affected by the treatment and no gross pathological findings were observed. Concluding, the LD50 in this study was ca. 615 mg/kg bw.

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

Study period:

1960

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: basic data given, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

BASF-Test to determine acute oral toxicity in rats in those days

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

4000, 2000, 1000, 500 mg/kg bw

No. of animals per sex per dose:

5 (except the high dose - only one animal was treated)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: observations daily and weighing at the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

female

Dose descriptor:

approximate LD50

Effect level:

ca. 0.5 mL/kg bw

Based on:

test mat.

Remarks on result:

other: ca. 615 mg/kg bw (density: 1.23 g/mL)

Mortality:

1/1 (4000 mg/kg bw); 5/5 (2000 mg/kg bw); 5/5 (1000 mg/kg bw); 2/5 (500 mg/kg bw) within 1-4 days following treatment

Clinical signs:

other: balance problems

Gross pathology:

no effect

Executive summary:

An acute oral toxicity study in female rats is available for the substance. In this study 500, 1000, 2000 and 4000 mg/kg bw of the undiluted test material was administered by gavage to 5 rats/dose group.

All applied doses were fatal for the animals within 1- 4 days following treatment. In the low dose group 3/5 survived. Balance problems was the only clinical effect observed in all treated animals. Body weights/body weight development was not affected by the treatment and no gross pathological findings were observed. Concluding, the LD50 in this study was ca. 615 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

615 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

A classification according to Regulation (EC) No 1272/2008, Annex I, is warranted:

Based on the (approximate) LD50 (oral): 615 mg/kg bw and the assumption of 100 % dermal absorption, the substance shall be allocated to hazard category 4 (H 302) for the oral route and to hazard category 3 (H 311) for the dermal route.