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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 for cross-reference:
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 for cross-reference:
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
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

1
Reference substance name:
Reference substance 001
Cas Number:
Not available

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system 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.