Reaction products of diazotised m-phenylendiamine, subsequently coupled with diazotised 4-aminobenzene-1-sulfonic acid, sodium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

other: read across from analogue substance

Adequacy of study:

weight of evidence

Study period:

17. Apr 1974 - 02. May 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1976

Materials and methods

Principles of method if other than guideline:

BASF-Test. The study was performed according to: Noakes D.N. and Sanderson D.M., A Method for Determining the Dermal Toxicity of Pesticides. Brit. Journ. Ind. Med. 26, 59, 1969.
5 animals were treated for 4 or 24 h using occlusive conditions. An application site of 50 cm² was covered with the test substance and the trunk of the rat was encircled with a strip of plaster (2 layers). After the exposure time the skin was washed with detergent and water. The animals were observed 8 days and skin changes were recorded daily.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 2

IUPAC Name:

Similar Substance 2

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WIGA
- Weight at study initiation: male: 144g (mean); female: 134g (mean)

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 cm²

REMOVAL OF TEST SUBSTANCE
- Washing: After the exposure time the skin was washed with detergent and water.

TEST MATERIAL
- Concentration (if solution): 100%
- Constant concentration used: yes

Doses:

5 ml/kg (equivalent to 5000 mg/kg)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Animals were weighted prior to exposure and symptoms were recorded daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: see overall remarks.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 850 mg/kg bw

Based on:

act. ingr.

Mortality:

No mortality was observed.

Clinical signs:

other: No abnormal clinical signs could be observed. All animals obtained local staining (brown) from residual substance.

Gross pathology:

No abnormalities were noted at necropsy.

Any other information on results incl. tables

Mortality:

Dose:	sex:	1h	24h	48h	7 days	14 days
5  ml/kg	male	0/5	0/5	0/5	0/5	0/5
5 ml/kg	female	0/5	0/5	0/5	0/5	0/5

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the available data the tested substance has no concern for acute dermal toxicity. Since the active substance in the tested sample is only 17% the LD50 dermal calculated on the active substance is 850 mg/Kg bw