Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: LD50 >5000 mg/kg bw (similar to OECD 401)

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:
The 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
Doses:
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 observed.
Clinical signs:
No effects observed
Body weight:
No data available
Gross pathology:
Necropsy performed: no effects
Other findings:
No other findings were reported.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 value of Guaiacwood oil in rats was established to be >5000 mg/kg body weight, under the conditions of this study. The substance therefore does not need to be classified in accordance with 1272/2008/EC (CLP).
Executive summary:

A single 5000 mg/kg bw dose of Guaiacwood 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 Guaiacwood oil in rats was established to be >5000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to be classified in accordance with the classification criteria outlined in 1272/2008/EC (CLP).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
This is the only study for this endpoint, conducted according to methods similar to OECD guideline 401 (limit test, pre-OECD, pre-GLP) and it is considered appropriate to be used as the basis for the chemical safety assessment.

Additional information

Acute oral toxicity

A single 5000 mg/kg bw dose of Guaiacwood oil was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. No mortality or other symptoms were observed. The oral LD50 value for Guaiacwood oil in rats was established to be >5000 mg/kg bw, under the conditions of this study.

Justification for classification or non-classification

The oral LD50 of Guaiacwood oil was determined to be higher than 5000 mg/kg bw. Based on the available information, the test substance is considered as non-toxic if swallowed and it does not need to be classified in accordance with the classification criteria outlined in Annex I of 1272/2008/EC (CLP).