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Administrative data

Description of key information

Acute toxicity oral (OECD Guideline 401): LD50 > 5000 mg/kg

Acute toxicity dermal (OECD Guideline 402): LD50 >5000 mg/kg

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:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
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
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:
one limit dose of 5000 mg/kg bw
No. of animals per sex per dose:
10 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: symptomatology
Preliminary study:
Not relevant.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was noted
Clinical signs:
No effects observed
Body weight:
No data available
Gross pathology:
Necropsy performed: no effects mentioned
Other findings:
Not other effects were reported
Interpretation of results:
other: not classified
Remarks:
based on CLP Regulation (1272/2008/EC)
Conclusions:
The oral LD50 value of Gurjon oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in CLP Regulation 1272/2008/EC (CLP).
Executive summary:

A single 5000 mg/kg bw dose of Gurjon oil was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. No symptoms or mortality were noted. The oral LD50 value of Gurjon oil 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 of the CLP Regulation 1272/2008/EC.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
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.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

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:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Test was conducted according to methods similar to OECD guideline 402 (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 402 (Acute Dermal Toxicity)
Version / remarks:
Limit test
GLP compliance:
no
Remarks:
pre-GMP
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: not specified
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg

Duration of exposure:
24h
Doses:
5000 mg/kg
No. of animals per sex per dose:
10 animals per dose, sex not specified
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
none
Clinical signs:
none
Body weight:
not specified
Gross pathology:
no effects reported
Other findings:
none
Interpretation of results:
other: Not classified
Remarks:
Based on CLP
Conclusions:
The dermal LD50 value of Gurjun oil in rabbits was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in annex 1 of CLP Regulation 1272/2008/EC (CLP).
Executive summary:

10 Rabbits were dermally exposed to 5000 mg/kg bw dose of Gurjun oil. The animals were observed for 14 days. No symptoms or mortality were noted. The dermal LD50 value of Gurjon oil 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 according to the classification criteria outlined in annex 1 of the CLP Regulation 1272/2008/EC.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Test was conducted according to methods similar to OECD guideline 402 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.

Additional information

Oral:

A single 5000 mg/kg bw dose of Gurjun oil was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. No symptoms or mortality were noted. The oral LD50 value of Gurjon oil 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 of the CLP Regulation 1272/2008/EC.

Dermal:

10 Rabbits were dermally exposed to 5000 mg/kg bw dose of Gurjun oil. The animals were observed for 14 days. No symptoms or mortality were noted. The dermal LD50 value of Gurjon oil 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 according to the classification criteria outlined in annex 1 of the CLP Regulation 1272/2008/EC.

Justification for classification or non-classification

Both the oral and dermal LD50 value of Gurjun oil was established as exceeding 5000 mg/kg body weight, under the conditions of the rat and rabbit studies described. The substance therefore does not need to be classified according to the classification criteria outlined in CLP Regulation 1272/2008/EC (CLP).