Octadecan-1-ol, ethoxylated

Endpoint summary

Description of key information

Oral (rat, m/f, OECD 401): LD50 > 21000 mg/kg bw

Conclusion based on data obtained with octadecan-1-ol, ethoxylated (CAS No. 9005-00-9, EC No. 500-017-8) 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

Reference 1

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

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

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

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)).

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.

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.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Justification for type of information:

Please refer to the category justification provided in the category object.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

For a detailed assessment of the acute oral toxicity of the Alcohol Ethoxylates (AE) category, please refer to the category justification attached to the category object.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.

Conclusions:

Applying read-across based on grouping of substances (category approach), no / low acute oral toxicity as expressed by a LD50 > 2000 mg/kg bw is predicted for the target substance.

Executive summary:

The available data on acute oral toxicity in the Alcohol Ethoxylates (AE) category indicate no / low acute toxicity for the target substance. As explained in the category justification, the differences in molecular structure and composition between the target substance and the members of the AE category are unlikely to lead to differences in the acute oral toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 21 000 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 octadecan-1-ol, ethoxylated (CAS No. 9005-00-9, EC No. 500-017-8) as well as several member substances of the Alcohol Ethoxylates (AE) category.

 

Study with octadecan-1-ol, ethoxylated (CAS No. 9005-00-9, EC No. 500-017-8)

The study addressing acute oral toxicity of octadecan-1-ol, ethoxylated (CAS No. 9005-00-9, EC No. 500-017-8) was conducted according to OECD guideline 401 (Food and Drug Research Laboratories, 1975a). Five Wistar rats (three males and two females) per dose received 2500, 5000, 10000, 20000 and 40000 mg/kg bw test substance by gavage and were observed for 14 days. Two deaths at 20000 mg/kg bw and five deaths at 40000 mg/kg bw occurred, resulting in a LD50 of > 21000 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 octadecan-1-ol, ethoxylated (CAS No. 9005-00-9, EC No. 500-017-8) 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).