Registration Dossier

Administrative data

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.

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:
not specified

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
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

Results and discussion

Preliminary study:
Not relevant
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:
No effects observed
Body weight:
No data available
Gross pathology:
Necropsy performed: no effects
Other findings:
No other findings were reported.

Applicant's summary and conclusion

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).