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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 March 1957 - 27 December 1957
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study pre-dates GLP and the standard guidelines; nevertheless, data is well reported and the experiment is conducted in accordance with generally accepted scientific principles.

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:
The acute dermal toxicity of the test material was investigated by occlusive exposure for 24 hours.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rabbit
Strain:
other: Albino
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Adult.
- Housing: Animals were caged individually.
- Diet: ad libitum.
- Water: ad libitum.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
- The rabbits were depilated over the entire trunk. Measured volumes of the test material were maintained in contact with the skin by means of a gauze bandage, over which a loose-fitting, impervious plastic sleeve was placed. The sleeve was constricted at both ends in order to prevent leakage of the test sample.
- At the end of the exposure period, the wrappings were removed and the skin wiped with absorbent cotton.
Duration of exposure:
24 hours
Doses:
Doses of 8 and 16 mL (7560 and 15120 mg, respectively) per kg bw.
No. of animals per sex per dose:
1 animal treated at the 8 mL dose level, 10 treated at the 16 mL dose level)
Control animals:
no
Details on study design:
- In a 14 day observation period, records were made of bodyweight, appearance and behaviour.

Results and discussion

Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 16 mL/kg bw
Based on:
test mat.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 15 120 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was seen.
Clinical signs:
The appearance and behaviour of the animals was normal throughout. Some transient skin irritation was seen however this was completely reversible within 4 to 7 days.
Body weight:
With the exception of 1 animal, all others maintained or gained weight. This is summarised in Table 1.

Any other information on results incl. tables

Table 1 Net Gain in Bodyweight

Dose

Rabbit No.

Net Gain in Bodyweight (g)

g/kg

mL/kg

7.56

8.0

1

470

 

 

 

 

15.12

 

 

 

 

 

16.0

2

3

4

5

6

7

8

9

10

11

0

100

100

500

300

300

0

-200

100

700

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was found to be not systemically toxic to the rabbit at doses of 8 and 16 mL/kg bw (equivalent to 7560 and 15120 mg/kg bw, respectively). The LD50 was considered to be greater than the highest dose tested, 16 mL/kg bw (15120 mg/kg bw). Under the conditions of the study, there is no requirement for the material to be classified in accordance with EU criteria.
Executive summary:

The potential of the test material to cause toxicity via the dermal route was assessed in the albino rabbit.

The depilated trunk of 11 rabbits was exposed to large doses of the test material for a period of 24 hours in an occlusive fashion. A single rabbit was treated with a dose of 8 mL/kg bw; 10 rabbits were treated with a dose of 16 mL/kg bw. Exposure was followed by a 14 day observation period.

No signs of systemic toxicity were observed. Behaviour, appearance and bodyweights (with the exception of 1 animal) were completely normal throughout the study. Some transient skin irritation was observed however this was completely reversed within 4 to 7 days.

 

The test material was found to be not systemically toxic to the rabbit at doses of 8 and 16 mL/kg (equivalent to 7560 and 15120 mg/kg bw, respectively). The LD50 is considered to be greater than the highest dose tested, 16 mL/kg bw (15120 mg/kg bw). Under the conditions of the study, there is no requirement for the material to be classified in accordance with EU criteria.