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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
Data is from peer- reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Safety Assessment of Isoparaffins as Used in Cosmetics
Author:
Wilbur Johnson, Wilma F. Bergfeld, Donald V. Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel Liebler, James G. Marks Jr., Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, F. Alan Andersen.
Year:
2012
Bibliographic source:
International Journal of Toxicology, vol. 31, suppl 3 : pp. 269S-295S, 2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Acute oral toxicity in mice by using 13475-82-6 (Isododecane).
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
yes

Test material

Constituent 1
Reference substance name:
2,2,4,6,6-Pentamethylheptane/
Cas Number:
13475-82-6
Molecular formula:
C12H26
IUPAC Name:
2,2,4,6,6-Pentamethylheptane/
Details on test material:
- Name of test material (as cited in study report): 2,2,4,6,6-Pentamethylheptane (Isododecane)
- Molecular formula (if other than submission substance): C12H26
- Molecular weight (if other than submission substance): 170.337 g/mole
- Substance type: Organic
- Physical state: No data
Purity Approx 85%
- Impurities (identity and concentrations): Approx 15%
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2,2,4,6,6-Pentamethylheptane (Isododecane)
- Molecular formula (if other than submission substance): C12H26
- Molecular weight (if other than submission substance): 170.337 g/mole
- Substance type: Organic
- Physical state: No data
Purity Approx 85%
- Impurities (identity and concentrations): Approx 15%

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
olive oil
Remarks:
10 %
Details on oral exposure:
not specified
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
not specified
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No moratlity observed
Mortality:
No mortality was observed at 2000 mg/kg bw.
Clinical signs:
not specified
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified

Any other information on results incl. tables

Table: Acute Oral Toxicity Study onIsododecane

Material

Predominant carbon length

Animals

Result

 

Isododecane (10% Olive oil)

C12

5 Mice

LD50 >2 g/kg

 

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
LD50 was considered to be > 2000 mg/kg when mice was treated with Isododecane orally.
Executive summary:

The acute oral toxicity study was conducted by using Isododecane in 5 mice in the concentration of 2000 mg/kg bw orally in 10%Olive oil.No mortality was observed at 2000 mg/kg bw. Therefore, LD50 was considered to be > 2000 mg/kg when mice were treated with Isododecane orally.