2-Ethylhexyl trans-4-methoxycinnamate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1977 - November 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

equivalent to OECD guideline 402 - scientifically acceptable

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

Prior to GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl 4-methoxycinnamate

EC Number:

226-775-7

EC Name:

2-ethylhexyl 4-methoxycinnamate

Cas Number:

83834-59-7

Molecular formula:

C18H26O3

IUPAC Name:

2-​Propenoic acid, 3-​(4-​methoxyphenyl)​-​, 2-​ethylhexyl ester, (2E)​-

Details on test material:

- Name of test material (as cited in study report): Ethylhexyl Methoxycinnamate
- Physical state: Liquid (sunscreen cream)
- Composition of test material, percentage of components: 2.5-7.5% Ethylhexyl Methoxycinnamate in sunscreen cream

Test animals

Species:

rat

Strain:

other: CFY

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 209 - 257 g

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: sunscreen cream

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorso-lumbar region
- % coverage: 10
- Type of wrap if used: Aluminium foil, held in place with "Sleek" waterproof plaster encircled firmly round the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm dilute soap solution (40 - 50 °C), followed by rinsing in clean warm water and finally blotting dry with absorbent paper.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Concentration (if solution): 2.5 - 7.5 % (Ethylhexyl Methoxycinnamate in sunscreen cream)
- Constant volume or concentration used: No

VEHICLE
- Amount(s) applied (volume or weight with unit): 5 mL/kg (maximum to be applied)

Duration of exposure:

24 hours

Doses:

126.3 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: weekly
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs

Statistics:

Not relevant

Results and discussion

Preliminary study:

Not relevant

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 126.3 mg/kg bw

Remarks on result:

other: No mortalities or signs of reaction to treatment

Mortality:

None of the ten animals (5 male, 5 female) died during study.

Clinical signs:

other: No observable dermal reactions at the site of application in either the treated or control animals were seen.

Gross pathology:

Terminal atopsy findings were normal.

Other findings:

Not relevant

Applicant's summary and conclusion

Interpretation of results:

other: not possible to derive a classification as no mortality was observed at dose applied

Conclusions:

The acute median lethal percutaneous dose (LD50) to rats of Ethylhexyl Methoxycinnamate was found to be greater than 126.3 mg/kg bodyweight, which was considered to be the maximum dosage.

Executive summary:

A sunscreen cream containing an end concentration of 2.5 - 7.5 % ethylhexyl methoxycinnamate is tested for acute dermal toxicity on male and female rats (5 per sex). Weight varied from 200 - 250 gram, and the maximal applicable dose is set at 5 mL/kg (representing a dose of 126.3 mg/kg bw ethylhexyl methoxycinnnamate). This dose is applied to the skin, occluded by aluminium foil and held there for 24 hours. After exposure, rats were observed for 14 days.

The study found no symptoms or mortality in any rat after 24 hours following a single dose. Loss of bodyweight was seen in female rats in week one, but this restored in week two. Weight gain of male rats was comparable to the control. Terminal autopsy findings were normal.

It was concluded that the dermal LD50 to rats for a cream containing up to 7.5 % Ethylhexyl Methoxycinnamate is greater than 126.3 mg/kg bw, which is considered to be the maximum dosage.