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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 > 10000 mg/kg bw

Conclusion based on data obtained with alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5) 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:
04 - 18 Nov 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1981
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Bor:WISW (SPF TNO)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: 107 g
- Housing: 1 - 5 animals in Macrolon cages (type III)
- Diet: R10 Alleindiät für Ratten, Ssniff Spezialfutter GmbH, Soest, Germany, ad libitum
- Water: Tap water, ad libitum
- Fasting period before study: 16 h
- Acclimation period: 4 - 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14 Nov 1986 To: 18 Nov 1986
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 11.905 mL/kg bw

DOSAGE PREPARATION: The test substance was heated to 50 °C and applied undiluted by oral gavage.
Doses:
10000 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 and weighing: weighing: prior to dosing and on Days 1, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
other: The only clinical sign of toxicity was piloerection. 2 h after dosing all animals were free of clinical signs.
Gross pathology:
No effects were observed.
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) > 10000 mg/kg bw was determined in a study according to OECD guideline 401.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 10 000 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, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5) as well as several member substances of the Alcohol Ethoxylates (AE) category.

 

Study with alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5)

The acute oral toxicity of alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5) was tested in a limit test according to OECD guideline 401 (Sasol, 1986a). Five Wistar rats (Bor:WISW) were dosed with 10000 mg/kg bw of the test substance by oral gavage and observed for 14 days. Animals were weighed prior to dosing and on Days 1, 7 and 14. Clinical signs were continuously monitored until 6 h after dosing and daily afterwards. Upon termination of the study, animals were subjected to gross necropsy. Treatment with the test substance did not cause mortality. All animals showed piloerection as the only clinical sign which ceased within 2 h post dosing. Body weight development was not affected by treatment and necropsy did not reveal any effects. The LD50 determined in this study is therefore > 10000 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, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5) 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).