Toluene-4-sulphonamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

1957

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limited reporting, none GLP, only one rabbit was dosed per dose level.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1957

Report date:

1957

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

6 rabbits were dosed with increasing amounts of test substance applied on the skin and observed for evidence of toxicity

GLP compliance:

no

Test type:

other:

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Toluenesulphonamide

EC Number:

215-578-1

EC Name:

Toluenesulphonamide

Cas Number:

1333-07-9

IUPAC Name:

2-methylbenzenesulfonamide

Constituent 2

Reference substance name:

Mixture of o-Toluenesulfonamide / p- Toluenesulfonamide (30:70)

IUPAC Name:

Mixture of o-Toluenesulfonamide / p- Toluenesulfonamide (30:70)

Test material form:

other: 25% suspension in corn oil

Details on test material:

Santicizer 9 (= 100% crystalline mixtuture of ortho- and para toluenesulfonamide 3:7)

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

BW of rabbits between 1.6 and 2.3 kg

Administration / exposure

Type of coverage:

not specified

Vehicle:

corn oil

Details on dermal exposure:

A 25% suspension in corn oil was applied to the closely clipped, intact skin of New Zealand rabbits and observations made for evidence of toxicity. The treated areas were covered with plastic shields and a leather collar placed around the neck of each animal to prevent access to the sample.

Duration of exposure:

No data

Doses:

2.0, 3.5, 5.0, 6.0, 7.5 and 7.5 g/kg bw based on tests substance (Highest dose level of 7.5 g/kg was applied to both a male and a female animal)

No. of animals per sex per dose:

1. Only highes dose 2 (one male and one female)

Control animals:

not required

Details on study design:

Examinations included: observations on clinical signs and body weight changes during 5 days.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

7 500 mg/kg bw

Based on:

test mat.

Mortality:

No mortality obsrved

Clinical signs:

other: No signs of systemic toxicity developed. Appetite and activity remained about normal. There was no evidence of paralysis such as developed when rabbits were fed the product orally.

Gross pathology:

Not performed

Any other information on results incl. tables

Animal	sex	BW in kg	Dose g/kg bw	BW change after 5 days	Results
1	Female	1.7	2.0	4.0%	survived
2	Male	2.1	3.5	6.0%	survived
3	Female	1.6	5.0	0.0%	survived
4	Female	1.9	6.0	5.0%	survived
5	Male	2.3	7.5	0.0%	survived
6	Female	2.0	7.5	3.0%	survived

The highest application of 7.5 g/kg bw was non lethal. No signs of systemic toxicity developed. Appetite and activity remained about normal. There was no evidence of paralysis such as developed when rabbits were fed the product orally.

The test article was not acutely toxic when applied to the skin of rabbits.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No mortality or systemic toxicity was observed following dermal application of 7500 mg/kg bw of o/p-TSA when applied as a 25% suspension in corn oil.

Executive summary:

The substance tested is a mixture of ortho-toluene sulfonamide (o-TSA: 30%) and para-toluenesulfonamide (p-TSA: 70%).

A 25% suspension in corn oil was applied to the closely clipped, intact skin of New Zealand rabbits and observations made for evidence of toxicity. The treated areas were covered with plastic shields and a leather collar placed around the neck of each animal to prevent access to the sample.

The following dose levels were applied on one animal each: 2.0, 3.5, 5.0, 6.0, 7.5 (male) and 7.5 (female) g/kg bw. Examinations included: observations on clinical signs and body weight changes during 5 days.

 

The highest application of 7.5 g/kg bw was non lethal. No signs of systemic toxicity developed. Appetite and activity remained about normal. There was no evidence of paralysis such as developed when rabbits were fed the product orally.

The test article was not acutely toxic when applied to the skin of rabbits.