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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 - 24 Sep 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of the Government of the United Kingdom
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C12-14, ethoxylated
EC Number:
500-213-3
EC Name:
Alcohols, C12-14, ethoxylated
Cas Number:
68439-50-9
Molecular formula:
n.a.
IUPAC Name:
Alcohols, C12-14, ethoxylated, < 2.5 EO

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Ltd., Margate, Kent, United Kingdom
- Age at study initiation: 5-8 weeks
- Weight at study initiation: 153-165 g (males) and 146 - 157 g (females)
- Fasting period before study: The animals were fasted overnight before dosing and for approx. 2 h after dosing
- Housing: in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: Rat and Mouse Expanded Diet No. 1 (Special Diets Services Limited, Witham, Essex, United Kingdom), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 49 - 53
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.23 mL/kg bw

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 30 min, 1, 2 and 4 h post dosing and once daily thereafter
- Frequency of weighing: prior to dosing on Day 0, on Day 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight

Results and discussion

Preliminary study:
A range-finding study was conducted in 1 male and 1 female. The animals were administered a single oral dose of 2000 mg/kg bw by gavage and observed for 5 days following treament. As no mortality and no clinical signs of toxicity became evident, the dose level of 2000 mg/kg bw was selected as limit dose for the main toxicity study.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
other: No signs of systematic toxicity were noted during the study.
Gross pathology:
No abnormalities were noted at necropsy.

Any other information on results incl. tables

Dose Level mg/kg Animal Number and sex Effects Noted After Dosing (Hours) Effects Noted During Period After Dosing (Days)
1/4 1 2 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14
2000 3-0 Male 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
3-1 Male 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
3-2 Male 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
3-3 Male 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
3-4 Male 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
4-0 Female 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
4-1 Female 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
4-2 Female 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
4-3 Female 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
4-4 Female 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0= no signs of systematic toxicity

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:
The acute oral LD50 of the test material was found to be greater than 2000 mg/kg bw.
Executive summary:

A study was performed to assess the acute oral toxicity of the test material in the Sprangue-Dawley CD strain rat. Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bodyweight. The animals were observed for 14 days after the day of dosing and were then killed and subjected to gross pathological examination. The acute oral median lethal dose (LD50) of the test material was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrase are required according to EU labelling regulations.