Benzenesulfonic acid, 2-amino-5-methyl-, sodium salt (1:1)

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 with acceptable restrictions (mostly due to reduced reporting in times before GLP)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1960

Report date:

1960

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

only 7 days postobservation period, higher doses

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

sodium 2-amino-5-methylbenzenesulfonate

EC Number:

611-210-2

Cas Number:

54914-95-3

Molecular formula:

C7 H8 N O3 S Na

IUPAC Name:

sodium 2-amino-5-methylbenzenesulfonate

Details on test material:

- Name of test material (as cited in study report): Natriumsalz der 4-Toluidin-3-sulfosaeure (sodium salt, pure, solid)
- Analytical purity: no data, pure

Test animals

Species:

mouse

Strain:

other: Tuebinger

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 19-32 g

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous solution in Traganth

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2% (up to 200 mg/kg bw)/10% (1600 mg/kg bw)/ 40% (>= 6400 mg/kg bw)

MAXIMUM DOSE VOLUME APPLIED: ca. 2.5 mg/kg bw

Doses:

200, 1600, 6400 and 10000 mg/kg bw

No. of animals per sex per dose:

5 females in each of the two lower doses, 10 females in each of the two higher doses

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Weighing was done only at the beginning of the study for dose calculation. Observation of clinical signs was several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 1/10 animals died in the 10000 mg/kg bw dose

Mortality:

1/10 animals died in the 10000 mg/kg bw dose within 24 hrs after application; no further lethality was observed

Clinical signs:

other: - 10000 mg/kg bw: very skittish 3 hrs after application. On the following day one animal showed complete apathy, lateral position before exitus; all other animals recovered completely within 24 hrs - 6400 mg/kg bw: slight apathy on the application day was

Gross pathology:

Sacrificed animals: nothing abnormal found
Animal that died: pale kidneys

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU