Benzyl cinnamate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

other: unpublished report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Principles of method if other than guideline:

The acute dermal toxicity of the test substance was tested in rabbits. The test material was applied once to the clipped backs of the animals, on both abraded and intact clipped skin areas, at dose levels of 1, 2 or 3 g/kg bw, under occlusive coverage for a period of 24 hours. After the exposure period of 24 hours the skin reactions were recorded and the animals were observed for signs of toxicity for the following 14 days.

GLP compliance:

no

Remarks:

test carried out pre-GLP-guideline

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzyl cinnamate

EC Number:

203-109-3

EC Name:

Benzyl cinnamate

Cas Number:

103-41-3

Molecular formula:

C16H14O2

IUPAC Name:

benzyl 3-phenylacrylate

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Diet (e.g. ad libitum): daily ration pellets
- Water (e.g. ad libitum): daily ration water
- Acclimation period: at least 2 weeks; hematology (red and white cell count, differential, grams hemoglobin, % hematocrit) and urinalysis was performed (on each animal), and eating habits and general appearance were observed.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE
- Back: clipped free of all hair; epidermal longitudinally abrasions every 2-3 cm (penetrated stratum corneum but not dermis (no bleeding)
- Area of exposure: clipped intact and abraded skin areas
- Type of wrap: rubber sleeve or dam
- time exposure: 24 hours

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes after 24 hours

TEST MATERIAL
- Concentration (if solution): 500 mg/mL
- Dose levels: 2 mL/kg bw (1 g active/kg), 4mL/kg bw (2g active/kg), 6mL/kg bw (3 g active/kg)
- For solids, paste formed: no

Duration of exposure:

24 hours

Doses:

2 mL/kg bw (1 g/kg bw), 4 mL/kg bw (2 g/kg bw), 6 mL/kg bw (3 g/kg bw)

No. of animals per sex per dose:

4 animals in total per dose, no information on sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Observations and weighing: body weights, general behaviour, food consumption
- Necropsy of survivors performed: no
- Other examinations performed: haematology and urinalysis

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

Moderate erythema, fully reversible within 48 hours.

Body weight:

The animals consumed their daily ration and gained weight and behaved as normal laboratory acclimated animals.

Gross pathology:

Comparison of their initial and final hematological values did not reveal any significant changes.

Any other information on results incl. tables

Examination of the treated backs after 24 hours showed moderate erythema but no edema or eschar formation and 24 hours later the treated backs showed a decrease in the degree of erythema. 48 hours after exposure the treated backs were normal.

Body weight:

	Body weight (kg)
	Initial	Final
2.0 mL/kg bw (1 g/kg bw)
Rabbit 1	2.6	2.8
Rabbit 2	2.5	2.9
Rabbit 3	2.7	2.8
Rabbit 4	3.0	3.1
4.0 mL/kg bw (2 g/kg bw)
Rabbit 5	3.0	3.2
Rabbit 6	3.0	3.1
Rabbit 7	2.7	2.8
Rabbit 8	2.8	3.0
6.0 mL/kg bw (3 g/kg bw)
Rabbit 9	3.0	3.2
Rabbit 10	3.0	3.1
Rabbit 11	2.6	2.9
Rabbit 12	2.6	2.7

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

The test item did not induce acute toxicity via the dermal route in rabbits up to a dose of 3000 mg/kg bw.

Executive summary:

In this study the acute dermal toxicity of the test substance was tested in rabbits. No guideline was followed and the study was not according to GLP.

The test material was applied once to the clipped backs of the animals, on both abraded and intact clipped skin areas. The dose levels were 1, 2 or 3 g/kg bw. The animals were covered with a rubber sleeve which fit snuggle around the animal. The animals were placed in an animal holder and exposed for a period of 24 hours.

After the exposure period of 24 hours, the rubber sleeves were removed and the skin reactions were recorded. Each animal was thoroughly wiped down and returned to its own metabolism cage to be observed for the following 14 days.

Examination of the treated backs after 24 hours showed moderate erythema but no edema or eschar formation and 24 hours later the treated backs showed a decrease in the degree of erythema. 48 hours after exposure the treated backs were normal.

The animals consumed their daily ration, gained weight and behaved normal. No animals died during the test and the animals did not show any toxicity signs, nor any significant differences between their initial and final hematogram. From these data an LD50 > 3000 mg/kg bw can be deduced.