Registration Dossier

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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
Skin irritation was observed in the rabbits: slight redness (1/10), moderate redness (1/10) and slight edema (3/10).
Body weight:
No data
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).