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Administrative data

Description of key information

Acute oral toxicity (OECD TG 401) LD50 >5000 mg/kg bw

Acuter dermal toxicity (OECD TG 402) LD50 >5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
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
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
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
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
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.
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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
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
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
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
No data

ENVIRONMENTAL CONDITIONS
No data
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
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
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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute oral toxicity

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.

Acute dermal toxicity

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.

Justification for classification or non-classification

Based on the available information, Ylang Ylang Ext., I and II does not need to be classified for acute toxicity in accordance with the classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).