4-(3-phenylpropyl)pyridine

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:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Acute dermal toxicity method predates establishment of guideline methods

Principles of method if other than guideline:

A standard Acute Toxicity Method was used which predates established guidelines and GLP

GLP compliance:

no

Remarks:

predates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

Yellowish Brown Liquid

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

All animals weighed between 2.5 and 3.0 kg.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

All animals had their backs clipped free of hair 24 hours prior to testing. All rabbits had their skin abraded prior to testing. Correct amount of experimental material was applied to the back of each animal. Treated areas were covered with large guaze patches and an impervious material was wrapped around the truck of each animal.

Duration of exposure:

The dressings were removed after 24 hours and any excess material was removed and the approximate amount remaining was noted. Each animal was observed for a period of 14 days for signs of toxicity.

Doses:

1.0 g/kg, equivalent to 1000 mg/kg bw,
2.0 g/kg, equivalent to 2000 mg/kg bw,
4.0 g/kg, equivalent to 4000 mg/kg bw.
8.0 gm/kg, equivalent to 8000 mg/kg bw.

No. of animals per sex per dose:

2 males and 2 females were each given one of the four available doses. 16 animals in total were used for the study.

Control animals:

no

Statistics:

no data

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 000 mg/kg bw

Based on:

test mat.

95% CL:

> 2 700 - < 6 000

Mortality:

Mortality was seen in doses of 4.0 g/kg bw and 8.0 g/kw body weight.
At 4.0 g/kg bw, 2 of the 4 rabbits died within 48-72 hours of the study.
At 8.0 g/kg bw, 4 of the 4 rabbits died within 48 hours of the study.

Clinical signs:

At 4.0 g/kg bw, the animals were seen to be severely depressed after 6-8 hours exposure of the test material. Deaths occured 48-72 hours afterwards.
At 8.0 g/kg bw, the animals were comatose within 24 hours of exposure to the test material, and died prior to 48 hours.

Gross pathology:

Gross autopsies were performed on all animals which died during the 14 day observation period. Gross pathological examination revealed nothing remarkable.

Any other information on results incl. tables

Animals exposed to high dose levels of the test material expressed depression, and comatose states. Deaths were also indicated at higher dose levels from 4.0 -8.0 g/kg bw. The LD50 of the test material is estimated to be 4.0 g/kg bw, equivalent to 4000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

LD50 > 2000 mg/kg bw.

Conclusions:

The LD50 of the test material in albino rabbits is 4.0 g/kg bw, equivalent to 4000 mg/kg bw.