Alcohols, C12-13, branched and linear, ethoxylated

Endpoint summary

Description of key information

Oral (similar OECD 401): LD50 (rat, m) = 14865 mg/kg bw, LD50 (rat, f) = 13627 mg/kg bw

Conclusion based on data obtained with alcohols, C12-13, branched and linear, ethoxylated (CAS No. 160901-19-9, EC No. 500-457-0) 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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

clinical signs of toxicity, body weight and gross necropsy findings were not included in the study report

GLP compliance:

no

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
- Source: Nossan - Correzzana, Milano, Italy
- Weight at study initiation: 200 g
- Fasting period before study:
- Housing: In groups of 5/cage in polycarbonate cages type Tecniplast (Gazzada, VA, Italy) with sawdust beddin.
- Diet: Pelleted complete diet
- Water: Tap water from the local network, filtered with Seitz filter, ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 55 ± 15
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 960, 800, 665 and 555 mg/mL
- Amount of vehicle: 20 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

11100, 13300, 16000 and 19200 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: The animals were observed for clinical signs and mortality at frequent intervals during the day of dose administration and once daily thereafter. Cageside observation included changes in the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomous and central nervous system, and somatomotor activity and behaviour pattern.
- Frequency of weighing: Rats surviving the observation period were weighed and compared to control animals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

The LD 50 value and attendant variation was determined from the results by the method given by Thompson-Weil.

Thompson and Weil(1952). Tables for Convenient Calculation of Median Effective Dose(LD50 on ED50) and Instructions in their use. Biometrics, 8, 51.

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

14 865 mg/kg bw

Based on:

test mat.

95% CL:

13 690 - 15 540

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

13 627 mg/kg bw

Based on:

test mat.

95% CL:

12 540 - 14 790

Mortality:

11100 mg/kg bw: 0/5 males and 1/5 females died (24 h post dosing)
13300 mg/kg bw: 2/5 males (24 and 48 h post dosing) and 2/5 females died (24 and 48 h post dosing)
16000 mg/kg bw: 3/5 males (1, 24 and 48 h post dosing) and 4/5 females died (1, 24 and 2x 48 h post dosing)
19200 mg/kg bw: 5/5 males (2 x 24 and 3 x 48 h post dosing) and 5/5 females died (1, 3 x 24 and 48 h post dosing)

Clinical signs:

other: Not reported

Gross pathology:

Not reported

Interpretation of results:

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

Conclusions:

Based on a study according to OECD guideline 401, the LD50 was 14865 mg/kg bw in male and 13627 mg/kg bw in female rats.

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:

> 13 000 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, C12-13, branched and linear, ethoxylated (CAS No. 160901-19-9, EC No. 500-457-0) as well as several member substances of the Alcohol Ethoxylates (AE) category.

 

Study with alcohols, C12-13, branched and linear, ethoxylated (CAS No. 160901-19-9, EC No. 500-457-0)

The study addressing acute oral toxicity of alcohols, C12-13, branched and linear, ethoxylated (CAS No. 160901-19-9, EC No. 500-457-0) was conducted similar to OECD guideline 401 (Sasol, 1984a). Five male and five female Wistar rats per dose received 11100, 13300, 16000 and 19200 mg/kg bw test substance by gavage and were observed for 14 days. Mortality was observed in all dose groups except for male animals in the low-dose group (11100 mg/kg bw). The LD50 values for males and females was determined according to the method described by Thompson-Weil. While for male rats a LD50 of 14865 mg/kg bw was established, a value of 13627 mg/kg bw for females was obtained.

 

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, C12-13, branched and linear, ethoxylated (CAS No. 160901-19-9, EC No. 500-457-0) 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).