Benzidine-2,2'-disulphonic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes

Author:

Draize JH

Year:

1944

Bibliographic source:

Journal of Pharmacology and Experimental Therapeutics 82: 377-390

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

A method of Draize et al. (1944) was followed. Neat material was held in contact with clipped skin for 24h (occlusive) by a rubber sleeve. Prior to exposure the subjects are prepared by clipping the skin of the trunk free of hair. The sleeve is slipped onto the animal which is then placed in a comfortable but immobilized position in a multiple animal holder. The doses of liquids and solutions are calculated on tile basis of body weight and introduced under the sleeve.

GLP compliance:

no

Test type:

other: study of 1944 as per the then existing guidelines

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl phthalate

EC Number:

205-011-6

EC Name:

Dimethyl phthalate

Cas Number:

131-11-3

Molecular formula:

C10H10O4

IUPAC Name:

dimethyl phthalate

Details on test material:

The read across has been considered from amongst the analogue generated by the QSAR model using the structural similarity principle
CAS No: 131-11-8
EC No: 205-011-6
IUPAC Name: dimethyl phthalate

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

14 days

Doses:

- 3.9, 6.0 and 9.4 ml/kg bw in a preliminary range finding
no further details on single doses given

No. of animals per sex per dose:

no data

Control animals:

not specified

Details on study design:

Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: blood morphology

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 12 000 mg/kg bw

Remarks on result:

other: calculated from original data 10 ml/kg (density 1.194 g/ml)

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

An experimental LD50 value of > 12000 mg/kg bw in rabbit was obtained for the read-across chemical (CAS No 131-11-3). In the absence of test data for the target chemical (CAS No 117-61-3) it is assumed that given the 60% structural similarity of the analogue to the target, benzidine-2,2'-disulphonic acid is assumed to not exhibit acute toxicity by the dermal route

Executive summary:

An experimental LD50 value of > 12000 mg/kg bw in rabbit was obtained for the read-across chemical (CAS No 131-11-3). In the absence of test data for the target chemical (CAS No 117-61-3) it is assumed that given the 60% structural similarity of the analogue to the target, benzidine-2,2'-disulphonic acid is assumed to not exhibit acute toxicity by the dermal route