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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 21 apr 1992 to 22 sept 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
slight variation of humidity.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-ethoxy-4-hydroxybenzaldehyde
EC Number:
204-464-7
EC Name:
3-ethoxy-4-hydroxybenzaldehyde
Cas Number:
121-32-4
Molecular formula:
C9H10O3
IUPAC Name:
3-ethoxy-4-hydroxybenzaldehyde

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Iffa-Crédo, BP 0109 (69592 L'Arbresle Cedex - France)
- Age at study initiation: 6 to 8 weeks old
- Weight at study initiation: 220 to 278 g
- Fasting period before study: no data
- Housing: in cages, colour-coded label showing the number and sex of each rat, the code numbers of the test article, of the test, of the group and of the study, the route of administration, the starting date of the test (a single label per cage).
- Diet (e.g. ad libitum): complete pelleted rat-mouse maintenance diet, ad libitum (U.A.R, formula A.04 C10 - U.A.R., Villemoisson - 91360 Epinay-sur-Orge, France).
- Water (e.g. ad libitum): softened and filtered mains drinking water, ad libitum. Bacteriological and chemical analyses twice a year.
- Acclimation period: at least 7 days before the start of the treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70% relative humidity
- Air changes (per hr): minimum 8
- Photoperiod (hrs dark / hrs light): 12h / 12h


IN-LIFE DATES: no data

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: purified water
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flanks
- % coverage: 10%
- Type of wrap if used: perforated adhesive band 10 cm wide, applied onto an elastic crepe bandage covering the entire shaved area to avoid any possible orthoergic reactions and encircling the trunk of the animal without interfering with the abdominal and respiratory movements of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any remaining test article was rinsed using lukewarm water only
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.887 mL/kg
- Concentration (if solution): 51.45% (w/v)
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
purified water, no more data
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: for mortality and clinical signs, 15 min after administration of the substance, then at 1, 2 and 4 hours, and daily for the 14 day study period.
Weight: day before treatment, immediately before treatment, on Day 8 and Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: gross pathology
Statistics:
none, limit test

Results and discussion

Preliminary study:
2 groups each composed of 2 males and 2 females were treated in the same conditions as those employed in the main study, at the dose levels of 1000 and 2000 mg/kg respectively. No deaths occured.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
no clinical signs
Body weight:
not influenced by treatment
Gross pathology:
no macroscopic findings
Other findings:
nothing

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
not classified
Executive summary:

In one acute dermal toxicity study of validity 1 (Hazleton, 1992), groups of Sprague-Dawley rats (5 males / 5 females per group) were dermally exposed to ethylvanillin for 24 hours at doses of 2000  mg/kg bw. 

The vehicle used was purified water. Animals then were observed for 14 days.

Clinical signs: no pathological signs were noted at 2000 mg/kg and no mortality was observed.

LD50 was higher than 2000 mg/kg.

Based on these results, Ethylvannilin is not considered harmful by contact with skin.