Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key 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.
Cross-reference
Reason / purpose:
reference to same study

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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
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.
Body weight:
BW increased in 5 days between 0 and 6%, without relation to dose level.
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:

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.