Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

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)