Ylang-ylang, ext.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ylang-ylang, ext.

EC Number:

281-092-1

EC Name:

Ylang-ylang, ext.

Cas Number:

83863-30-3

IUPAC Name:

Essential oil of Ylang Ylang Ext/I/II obtained from the flowers of Cananga odorata (Annonaceae) by steam distillation

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Ylang oil extra
- Purity: No data
- Lot/batch No.: confidential

Specific details on test material used for the study:

- Name of test material (as cited in study report): Ylang oil extra
- Purity: No data
- Lot/batch No.: Confidential information

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
No data

ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

No data

Duration of exposure:

Single administration

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following exposure: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: No
- Other examinations performed: Clinical signs

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: Skin irritation was observed in the rabbits: slight redness (1/10), moderate redness (1/10) and slight edema (3/10).

Gross pathology:

No data

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

based on CLP criteria (Annex I of 1272/2008/EC)

Conclusions:

The dermal LD50 value of Ylang Oil Extra in rabbits was established to be higher than 5000 mg/kg bw, under the conditions of this study. The substance therefore does not need to be classified for acute dermal toxicity according to the classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

Ten rabbits were exposed to a single dose of 5000 mg/kg bw Ylang oil Extra. The animals were observed for 14 days. No mortality was noted. Skin irritation (slight and moderate redness, slight edema) was observed. The dermal LD50 value for Ylang oil Extra in rabbits was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to be classified for acute dermal toxicity according to the classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).