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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Information taken from a review hydrocarbon toxicity for use in cosmetics; method details lacking
New animal testing cannot be performed as use is only for cosmetics
The class of substance has a history of use in consumer products and is not considered hazardous to health (other than Aspiration Toxicity)

Data source

Reference
Reference Type:
review article or handbook
Title:
Mineral oils and waxes in cosmetics: an overview
Author:
B. Chuberre, E. Araviiskaia, T. Bieber, A. Barbaud4,
Year:
2019
Bibliographic source:
JEADV 2019, 33 (Suppl. 7), 5–14

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
Details not provided, but apparently limit test cited
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
White mineral oil (petroleum)
EC Number:
232-455-8
EC Name:
White mineral oil (petroleum)
Cas Number:
8042-47-5
Molecular formula:
C15 - C50
IUPAC Name:
White mineral oil
Test material form:
liquid

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
Dose levels of > 5000 mg/kg
No. of animals per sex per dose:
Not specified
Control animals:
not specified

Results and discussion

Preliminary study:
Not performed
Effect levels
Sex:
not specified
Dose descriptor:
discriminating dose
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
other: No clinical signs
Gross pathology:
No adverse effects reported
Other findings:
No adverse effects reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Low hazard
Information taken from a review hydrocarbon toxicity for use in cosmetics
New animal testing cannot be performed as use is only for cosmetics
The class of substance has a history of use in consumer products and is not considered hazardous to health (other than Aspiration Toxicity)