4-trans-propenylveratrole

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Pre-guideline and pre-GLP study. Only basic data given, but considered sufficiently reliable for the purpose of hazard assessment.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

(no details on test animals, environmental condition of animal room, dermal exposure (duration, occlusive-dressing or not), body weight, pathology findings)

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-prop-1-enylveratrole

EC Number:

202-224-6

EC Name:

4-prop-1-enylveratrole

Cas Number:

93-16-3

Molecular formula:

C11H14O2

Test material form:

not specified

Details on test material:

None

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Type of coverage:

not specified

Vehicle:

not specified

Details on dermal exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw

Duration of exposure:

No data

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

6 animals/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs and mortality daily for 14 days.
- Necropsy of survivors performed: No data

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: One animal died on Day 11.

Mortality:

- 1/6 animal died on Day 11 post exposure.

Clinical signs:

other: - Dermal irritation was observed in animals.

Gross pathology:

No data

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 and to the GHS as the LD50 is greater than 5000 mg/kg bw.

Executive summary:

In an acute dermal toxicity study (limit test), the skin of six rabbits was exposed to test material at dose of 5000 mg/kg bw. Animals were observed for mortality and clinical signs at least daily for 14 days. 1/6 animal died on Day 11 post exposure. Dermal irritation was observed in animals.

Rabbit Dermal LD50 > 5000 mg/kg bw

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.