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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:
no clinical signs
Body weight:
Male rats: The mean bodyweight increased from 175g (on the day before the study started) to 237g on day 14.
Female rats: The mean bodyweight increased from 170g (on the day before the study started) to 185g on day 14.
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.