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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August to October 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
17 December 2001
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Guerbet alcohols, C24-26, branched and cyclic
EC Number:
942-520-9
Cas Number:
2041102-78-5
Molecular formula:
not applicable, UVCB
IUPAC Name:
Guerbet alcohols, C24-26, branched and cyclic
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Isofol 2426 S
- Substance type: pure active substance
- Physical state: colourless liquid
- Storage condition of test material: room temperature: 20 ± 5 °C

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER LABS (53940 Le Genest St Isle, France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 187-210 g
- Fasting period before study: on day of dosing until 4 hours after dosing
- Housing: single in Macrolon cages (type II)
- Diet : A04, SAFE (ad libitum)
- Water: tap water (ad libitum)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70 %
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: September 8, 2015 To: September 23, 2015

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
single application by gavage
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: body weights were determined before the study and on days 2, 7 and 14
Statistics:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: none
Gross pathology:
The macroscopic examination of the animals did not reveal treatment related changes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance Guerbet alcohols, C24-26, branched and cyclic is practically nontoxic after oral administration of 2000 mg/kg bw to rats.
Executive summary:

The substance Guerbet alcohols, C24-26, branched and cyclic is practically nontoxic after oral administration to rats. No mortality occured after oral administration of 2000 mg /kg bw.