Benzyl cinnamate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Principles of method if other than guideline:

Groups of test animals (10 per dose group) received the test substance dissolved in corn oil (500 mg/mL) via oral gavage.
Doses ranged from 2.0 to 5.0 g per kg bw. Animals were observed for 14 days post treatment.

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:

rat

Strain:

other: Charles River

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: 48 hours
- Housing: wire mesh cages in air conditioned room
- Diet: regular diet of Lab Blox; ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Concentration: 500 mg/mL (w/v)

Doses:

2.0, 2.25, 3.0 and 5.0 g/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food consumption

Statistics:

Oral LD50 was calculated according to the method of Litchfield, V.T. and Wilcoxon, F., Journal of Pharmacology and Experimetnal Therapeutics, Vol 96, p 99, 1949.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 280 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 620 - <= 4 100

Mortality:

8 animals dosed with 5 g/kg bw died within 24 hours post-dosing, the remaining 2 showed a normal increase in body weight at the end of the 14 days observation period.

Clinical signs:

Animals dosed with 5 g/kg bw showed CNS effects 18 hours post-dosing.
Animals dosed at the three lower levels did not show any symptoms prior to death and behaved as normal laboratory animals.

Body weight:

Normal body weight increase.
All surviving animals ate well.

Any other information on results incl. tables

Results:

Doses (g/kg bw)	Response (deaths)	% observed	% expected	Observed minus expected	(CHI)^2
2.0	2/10	20	17	3	.006
2.25	2/10	20	23	3	.005
3.0	4/10	40	43	3	.004
5.0	8/10	80	79	1	.015

N¹ = 40

ED84 = 5.48

ED50 = 3.28

ED16 = 1.96

S= [(ED84/ED50) + (ED50/ED16)] / 2 = 1.67

fED50 = S^2.77 / √ N¹= 1.25

ED50 * fED50 = 4.1

ED50 / fED50 = 2.62

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 oral LD50 was calculated to be 3.28 g/kg bw with 19/20 confidence limit of 2.62 to 4.1 g/kg bw.

Executive summary:

In the current study the oral LD50 of the test substance was determined in rats in an oral (gavage) acute toxicity test.

No OECD guideline was followed and the study was not GLP.

The rats were fed 2.0, 2.25, 3.0 or 5.0 g/kg bw of the test material dissolved in corn oil, via a rigid stomach tube. 10 animals per dose were used. Following the administration of each dose level the animals were observed for 14 days for signs of toxicity.

8/10 animals dosed with 5 g/kg bw died within 24 hours post-dosing, the remaining 2 showed a normal increase in body weight at the end of the 14 days observation period. All surviving animals ate well and gained body weight in a normal way.

Animals dosed with 5 g/kg bw showed CNS effects 18 hours post-dosing. Animals dosed at the three lower levels did not show any symptoms prior to death and behaved as normal laboratory animals.

The oral LD50 was calculated to be 3.28 g/kg bw with 19/20 confidence limit of 2.62 to 4.1 g/kg bw.

As the LD50 > 2,000 mg/kg bw, the test item is not to be classified as acute toxic according to the CLP regulation.