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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test was conducted according to methods similar to OECD guideline 401 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.

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 401 (Acute Oral 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:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: approximately 200 g
- Fasting period before study: 16-18 hrs
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
No data available
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 administration: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: No
- Other examinations performed: symptomatology

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
Coma and chromodacryorrhea were seen 24 hours post-treatment. These effects had disappeard 48 hours after treatment.
Body weight:
No data available.
Gross pathology:
No effects were observed during necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
based on CLP criteria (Annex I of 1272/2008/EC)
Conclusions:
The oral LD50 value of Ylang oil Extra in rats 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 according to the classification criteria outlined in Annex I of the CLP Regulation 1272/2008/EC.
Executive summary:

A single 5000 mg/kg bw dose of Ylang oil Extra was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. No mortality was noted. Coma and chromodacryorrhea were observed 24 hours post-treatment, effects that could no longer be detected 48 hours after treatment.The oral LD50 value for Ylang oil Extra in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to be classified according to the classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).