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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:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.
Justification for type of information:
Information is used for read across to Patchouli Alcohol
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: read-across information
Justification for type of information:
The read across rationale for this substance is presented in the Acute Toxicity Endpoint summary, the documents are also attached there.
Reason / purpose:
read-across source
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: Not acute harmful.
Remarks:
According to EU CLP Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
The substance has an LD50 >5000 mg/kg bw.

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)
Deviations:
yes
Remarks:
no details on test animals and environmental conditions
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
No details.

ENVIRONMENTAL CONDITIONS
No details.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
gavage
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Total 10 (no sex specified)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
No clinical signs were observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not acute harmful.
Remarks:
According to EU CLP Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
An LD50 of >5000 mg/kg bw was obtained in the acute oral toxicity study with rats similar to OECDTG 401.
Executive summary:

In an acute oral toxicity study one groups of 10 rats were orally exposed to 5000 mg/kg bw of the substance in as study similar to OECD TG 401, pre-guideline and pre-GLP. The rats were observed for signs of toxicity and clinical signs for a period of 14 days. No deaths occurred and no clinical signs were observed. Based on the results, an LD50 of >5000 mg/kg bw was obtained in the acute oral toxicity study with rats and is not considered harmful.