Registration Dossier

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:
other: equivalent to OECD guideline 402 - scientifically acceptable
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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 degrees Celsius), 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
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:
No observable dermal reactions at the site of application in either the treated or control animals were seen.
Body weight:
Loss of bodyweight was observed in four female treated rats during the first week of observation, but returned to normal during the second week compared to the controls. The bodyweight gains of the male treated were similar to the controls.
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
Remarks:
Criteria used for interpretation of results: EU
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.