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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientific expert review of experimental data deemed reliable and valid
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
other: review of experimental data by an expert panel
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientific expert review of experimental data deemed reliable and valid
Qualifier:
no guideline required
Principles of method if other than guideline:
Experimental and estimated data (from (Q)SAR and Categories) was reviewed, and expert judgement was applied for determining if human health or environmental effects existed which would lead to reconsidering the appropriateness of listing according to Annex IV criteria.
GLP compliance:
no
Species:
rat
Sex:
not specified
Route of administration:
other: estimated that the route would be oral gavage
Details on study design:
Extrapolation from experimental repeated dose toxicity study where NOAEL > 5000 mg/kg bw/d (NTP, 1992).
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Expert judgement: LD50 > 5000 mg/kg bw (read across from repeat dose toxicity).
Other findings:
Extracted from the (M)SDS of the product: "May cause digestive tract irritation. It is considered a purgative and stimulates smooth muscle of the digestive tract."
Interpretation of results:
GHS criteria not met
Conclusions:
After review of the repeated dose toxicity study of 1992 (NTP), the expert panel evaluating REACH Annex IV listings estimated that the LD50 of castor oil is greater than 5000 mg/kg bw.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Experimental and estimated data (from (Q)SAR and Categories) was reviewed, and expert judgement was applied for determining if human health or environmental effects existed which would lead to reconsidering the appropriateness of listing according to Annex IV criteria.
GLP compliance:
no

Test material

Constituent 1
Test material form:
solid: flakes

Test animals

Species:
rat
Sex:
not specified

Administration / exposure

Route of administration:
other: estimated that the route would be oral gavage
Details on study design:
Extrapolation from experimental repeated dose toxicity study where NOAEL > 5000 mg/kg bw/d (NTP, 1992).

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:
Expert judgement: LD50 > 5000 mg/kg bw (read across from repeat dose toxicity).
Other findings:
Extracted from the (M)SDS of the product: "May cause digestive tract irritation. It is considered a purgative and stimulates smooth muscle of the digestive tract."

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
After review of the repeated dose toxicity study of 1992 (NTP), the expert panel evaluating REACH Annex IV listings estimated that the LD50 of castor oil is greater than 5000 mg/kg bw. This supports the suggestion that a related substance, GMHS, is acutely nontoxic.