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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
-Study performed similar to OECD guideline 423 (Acute Oral Toxicity - Acute Toxic Class Method) - Assessment supported with ToxRTool (Schneider K. et al. "ToxRTool", a new tool to assess the reliability of toxicological data. Toxicol Lett. 2009 Sep 10;189(2):138-44.)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
5 male and 5 female rats in one step
GLP compliance:
no
Remarks:
in agreement with OECD GLP principles from 1983
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Alcohols, C6-24, distn. residues
EC Number:
310-080-1
EC Name:
Alcohols, C6-24, distn. residues
Cas Number:
102242-49-9
Molecular formula:
Not available for this UVCB (see Remarks)
IUPAC Name:
Alcohols, C6-24, distn. residues
Details on test material:
- Name of test material (as cited in study report): Fettalkoholdestillationsrückstand, alkalisch
- Physical state: solid (paste)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen (Germany)
- Fasting period before study: 16h
- Housing: 5 rats per Makrolon 3 cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45 - 60
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in %: 20

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: as the substance was not expected to be acute toxic, the max. concentration of 2000 mg(kg bw was selected.
Doses:
2000 mg/kg bodyweight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
other: no clinical signs
Gross pathology:
no findings
Other findings:
- Organ weights: not stated
- Histopathology: not stated
- Potential target organs: not stated
- Other observations: not stated

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of a study similar to OECD test guideline 423, i.e. a LD50 of > 2000 mg/kg bw , the test substance is considered to be practically non-toxic via the oral route.
Executive summary:

The acute oral toxicity of the test substance was investigated in a limit test study with the does of 2000 mg/kg bodyweight in a study similar to OECD test guideline 423. The study was performed in agreement with the OECD GLP-principles. To 5 female and 5 male Wister rats, the test substance was administered by oral gavage. No mortality, nor clinical signs were observed over 14d, while the bodyweight increased normally. According to these results, with a LD50 of > 2000 mg/kg bodyweight the test substance is considered practically non-toxic via the oral route.