(E)-anethole

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(E)-anethole

EC Number:

224-052-0

EC Name:

(E)-anethole

Cas Number:

4180-23-8

Molecular formula:

C10H12O

IUPAC Name:

1-methoxy-4-prop-1-en-1-ylbenzene

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Sex: Females, nulliparous and non-pregnant
Acclimatisation period: At least 10 days
Age and weight range: 9 to 11 weeks old, approximately 2 kg
Housing: Polycarbonate/stainless steel cages measuring 65.3x65.3x45 cm with perforated NorylTM floor suspended over trays
Water supply: ad libitum
Diet: STANRAB (P) SQC, Special Diets Services, Witham, Essex CM8 3AD, UK
Diet supply: ad libitum throughout the study
Room lighting: Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
Air changes: Approximately 15 to 20 air changes per hour
Temperature range: 19°C ± 2°C
Relative humidity range: 55% ± 15%

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Controls:

no

Amount / concentration applied:

Dose calculation: 0.5 mL for each animal
Treatment area preparation: On the day before dosing. A single area was clipped free of hair (by electric clipper equipped with a suitable blade) on both sides of the mid-line of the dorsal surfaces of the trunk of each animal (approximately 15 cm long by 10 cm wide). Care was taken to avoid damage to the skin.
Dosing procedure: An aliquot of the supplied test item was spread evenly over a square gauze measuring 25 x 25 mm. The square gauze was then placed onto the animal’s skin with the test item in direct contact with the skin. A strip of synthetic film was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage, this forming a semi-occlusive barrier.

Duration of treatment / exposure:

Exposure time : 4 hours

Observation period:

Approximately 1, 24, 48 and 72 hours after the end of the 4 hour exposure period.
Additional examination: Day 8

Number of animals:

3

Results and discussion

In vivo

Results

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Irritation
No erythema or oedema was noted at the observation performed approximately 1 hour after dosing. Very slight erythema (score of 1) was observed in all treated animals during the 24 hour observation. One animal recovered at 48 hour examination, whereas for 2/3 animals recovery occurred by Day 8 of the study.

Other effects:

Systemic effects and clinical signs: There was no indication of a systemic effect and no clinical signs were observed.

Body weight: Changes in body weight, seen during the course of the study, were not remarkable.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Classification: No category
Signal word: No signal word required
Hazard statement: No hazard statement required