Butylhydroxyoxostannane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Young adult albino rabbits of the New Zealand strain were used as test animals. Twenty-four hours prior to the dermal applications, the backs of the rabbits were shaved free of hair with electric clippers. A range of several dose levels was studied using 1 rabbit per level. The test site of each animal was covered by wrapping the trunk with impervious plastic sheeting which was securely taped in place. The test material remained in contact with the skin for 24 hours. At the end of this period, the plastic sheeting and all residual test material were removed. The test sites were examined for local skin reactions and the animals were returned to their cages. Observations for mortality, local skin reactions and behavioural abnormalities were continued for a total of 14 days following the skin applications. Initial, 7- and 14-day body weights were recorded. A necropsy examination was conducted on all animals.

GLP compliance:

no

Remarks:

study pre-dates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butylhydroxyoxostannane

EC Number:

218-880-1

EC Name:

Butylhydroxyoxostannane

Cas Number:

2273-43-0

Molecular formula:

C4H10O2Sn

IUPAC Name:

butyl(oxo)stannanol

Test material form:

solid: particulate/powder

Details on test material:

- Appearance: white powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young
- Weight at study initiation: 2.86 - 2.98 g
- Housing: The rabbits were housed individually in suspended, wire-bottomed cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Remarks:

the test material was applied as an aqueous slurry

Details on dermal exposure:

TEST SITE
- Area of exposure: Back
- % coverage: 30%
- Twenty-four hours prior to the dermal applications, the backs of the rabbits were shaved free of hair with electric clippers. The shaved area on each animal constituted about 30 percent of the total body surface area. The animals were then returned to their cages to await testing on the following day. The 24-hour waiting period allowed recovery of the stratum corneum from the disturbance which accompanied the close-clipping procedure and permitted healing of any microscopic abrasions possibly produced during the process.
- Type of wrap if used: The test site of each animal was covered by wrapping the trunk with impervious plastic sheeting which was securely taped in place. This plastic wrap insured close contact of the epidermis and test material. To prevent oral ingestion of the test material, each animal was fitted with a lightweight, flexible plastic collar which was worn throughout the observation period.

REMOVAL OF TEST SUBSTANCE
- The test material remained in contact with the skin for 24 hours. At the end of this period, the plastic sheeting and all residual test material were removed.

TEST MATERIAL
- Applied as an aqueous slurry to abraded skin sites

Duration of exposure:

24 hours

Doses:

200, 500 2000 mg/kg

No. of animals per sex per dose:

1 animal per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Observations for mortality, local skin reactions and behavioural abnormalities were continued for a total of 14 days following the skin applications.
- Initial, 7- and 14-day body weights were recorded.
- A necropsy examination was conducted on all animals.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the observation period.

Clinical signs:

other: No pharmacotoxic symptoms were observed in the rabbits following dermal exposure to the test material. The test material was non-irritating to the skin of the albino rabbit.

Gross pathology:

Necropsy examination revealed a cyst on the liver and a haemorrhage in the lung in rabbit 2-M. These lesions appeared to be associated with naturally occurring disease. No other gross pathologic alterations were found.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU Criteria.

Conclusions:

Under the conditions of this study the acute dermal LD50 was greater than 2000 mg/kg.

Executive summary:

The acute dermal toxicity of the test material was investigated using young adult male New Zealand White rabbits.

Twenty-four hours prior to the dermal applications, the backs of the rabbits were shaved free of hair with electric clippers. A range of several dose levels was studied using 1 rabbit per level. The test site of each animal was covered by wrapping the trunk with impervious plastic sheeting which was securely taped in place. The test material remained in contact with the skin for 24 hours. At the end of this period, the plastic sheeting and all residual test material were removed. The test sites were examined for local skin reactions and the animals were returned to their cages. Observations for mortality, local skin reactions and behavioural abnormalities were continued for a total of 14 days following the skin applications. Initial, 7- and 14-day body weights were recorded. A necropsy examination was conducted on all animals.

No mortality occurred during the observation period. No pharmacotoxic symptoms were observed in the rabbits following dermal exposure to the test material. The test material was non-irritating to the skin of the albino rabbit.

Necropsy examination revealed a cyst on the liver and a haemorrhage in the lung in rabbit 2-M. These lesions appeared to be associated with naturally occurring disease. No other gross pathologic alterations were found.

Under the conditions of this study the acute dermal LD50 was greater than 2000 mg/kg.