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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Nov 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
limited reporting, no details on animals and animal accomodation and test procedure; no body weights recorded, no gross macroscopic examination performed, clinical signs of toxicity not reported
GLP compliance:
no
Remarks:
Prior to implementation of GLP.
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Octadecan-1-ol, ethoxylated
EC Number:
500-017-8
EC Name:
Octadecan-1-ol, ethoxylated
Cas Number:
9005-00-9
Molecular formula:
not applicable, UVCB
IUPAC Name:
2-octadecoxyethanol

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adults
- Weight at study initiation: 200 - 300 g
- Fasting period before study: The animals were fasted for 24 h prior to dose administration
- Housing: in mesh buttom cages
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2.5, 5, 10, 20 and 40 g/kg bw
No. of animals per sex per dose:
3 males and 2 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed daily.
- Necropsy of survivors performed: no
Statistics:
The LD50 was calculated according to the method of Miller and Tainter (Proc. Soc. Biol. Med. 57, 261 (1944)).

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 21 000 mg/kg bw
Based on:
test mat.
Mortality:
At 20 g/kg bw, 2/5 animals died on study Days 1 and 6.
At 40 g/kg bw, 5/5 animals died on the day of dosing.
Clinical signs:
other: other: No data.
Gross pathology:
No data.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
For the test substance a LD50 (rat, m/f) > 21000 mg/kg bw was determined in a study according to OECD guideline 401.