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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Oral (rat, m/f, OECD 401): LD50 > 2000 mg/kg bw

Conclusion based on data obtained with alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) and considering all available data on acute toxicity in the Alcohol Ethoxylates (AE) category in a Weight-of-Evidence approach.

Inhalation: No study required as the inhalation route of exposure is considered less relevant than the dermal route for AE substances.

Dermal: According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, no study is required as the AE substances do not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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
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.
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw
Quality of whole database:
The available information comprises adequate and reliable (Klimisch score 1 and 2) studies from various substances in the Alcohol Ethoxylates (AE) category with similar structures and intrinsic properties. Read-across is justified based on common toxicokinetic behaviour and consistent trends in environmental fate, ecotoxicological and toxicological properties of the category member substances. The database of the AE category is thus sufficient to fulfil the standard information requirements set out in Annex VII, Section 8.5, in accordance with Annex XI, Section 1.5, of the REACH Regulation (EC) No. 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity: oral

Data on acute oral toxicity are available for alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) as well as several member substances of the Alcohol Ethoxylates (AE) category.

 

Study with alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3)

The acute oral toxicity of alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) was investigated in a limit test according to OECD guideline 401 observing GLP conditions (Kao, 1996a). Five Wistar rats of each sex were dosed with 2000 mg/kg bw of the test substance by oral gavage (dose volume: 2.23 mL/kg bw). The animals were observed for deaths or overt signs of toxicity 30 min, 1, 2 and 4 h after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14. At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. Treatment with the test substance did not cause mortality and no clinical signs were observed in any animal. Body weight development was not affected by treatment and necropsy did not reveal any effects. The LD50 value determined in this study is therefore > 2000 mg/kg bw.

 

Studies in the AE category

Studies investigating acute oral toxicity are available for the following AE substances:

 

CAS No.

EC No.

Substance

Study protocol

Hazard conclusion

68439-50-9

500-213-3

Alcohols, C12-14, ethoxylated

OECD 401

LD50 (rat, male/female) > 2000 mg/kg bw

68439-49-6

939-518-5

Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO

OECD 401

LD50 (rat, male/female) > 10000 mg/kg bw

9005-00-9

500-017-8

Octadecan-1-ol, ethoxylated

OECD 401

LD50 (rat, male/female) > 21000 mg/kg bw

66455-14-9

500-165-3

Alcohols, C12-13, ethoxylated

Similar OECD 401

LD50 (rat, male/female) > 2000 mg/kg bw

160901-19-9

500-457-0

Alcohols, C12-13, branched and linear, ethoxylated

Similar OECD 401

LD50 (rat, male) = 14865 mg/kg bw

LD50 (rat, female) = 13627 mg/kg bw

 

Evaluation of acute oral toxicity as observed in studies

All available study results indicate a very low acute oral toxicity, thus demonstrating similar toxicological properties of the AE substances in regard to acute oral toxicity. The only sign of systemic toxicity was ruffled fur which was observed with alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5) at a dose of 10000 mg/kg bw. However, the effect ceased within 2 h post dosing. In all studies, animals showed the expected gain in bodyweight and no abnormalities were noted at the terminal necropsy of the animals. The LD50 values determined are consistently > 2000 mg/kg bw. Therefore, no / low acute oral toxicity and a LD50 > 2000 mg/kg bw is predicted for all substances in the AE category lacking acute oral toxicity data.

This evaluation is considered sufficiently conclusive for the hazard assessment and classification and labelling of the AE substances. For a detailed evaluation of the acute toxicity of the substances in the AE category, please refer to the category justification attached to the category object.

 

Acute toxicity: inhalation

No data on acute toxicity via the inhalation route of exposure are available for AE substances as the inhalation route is considered less relevant than the dermal route.

 

Acute toxicity: dermal

No data on acute dermal toxicity are available for AE substances as none of the substances meets the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).

Justification for classification or non-classification

The available data on acute oral toxicity obtained with alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) and with other members of the Alcohol Ethoxylates (AE) category do not meet the criteria for classification according to the CLP Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.

No information on acute toxicity via the inhalation and dermal routes of exposure are available for AE substances because the inhalation route is considered less relevant than the dermal route and the AE substances do not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).