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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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