Isotridecanol, ethoxylated

Endpoint summary

Description of key information

Oral (rat): LD50 > 2000 mg/kg bw

Read-across (Weight-of-Evidence approach) based on the analogue source substances isotridecanol, ethoxylated, 3 EO (CAS No. 69011-36-5), isotridecanol, ethoxylated, 3-4 EO (CAS No. 69011-36-5) and 11-methyldodecan-1-ol (isotridecanol, CAS No. 27458-92-0, EC No. 248-469-2).

Inhalation: No study required as the inhalation route of exposure is considered less relevant than the dermal route for isotridecanol, ethoxylated, < 2.5 EO (CAS No. 69011-36-5, EC No. 500-241-6).

Dermal: LD50 > 2000 mg/kg bw

Read-across (Weight-of-Evidence approach) based on the analogue source substances alcohols, C12-13, ethoxylated, < 2.5 EO (CAS No. 66455-14-9, EC No. 500-165-3) and 11-methyldodecan-1-ol (isotridecanol, CAS No. 27458-92-0, EC No. 248-469-2).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

Please refer to the Analogue Approach Justification provided in Section 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Source: CAS 69011-36-5 (3-4EO), 1999, BASF, 10A0505/989143

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Source: CAS 69011-36-5 (3EO), 1986a, Sasol, 2682

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Source: CAS 27458-92-0, 2002, BASF, 10A0325/011047

Clinical signs:

other:

Interpretation of results:

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

Conclusions:

An acute oral LD50 > 2000 mg/kg bw was determined for the target substance in a Weight-of-Evidence approach considering adequate analogue source substances.

Executive summary:

The acute oral toxicity of the target substance is assessed based on adequate and reliable in vivo studies of structural analogue source substances in a Weight-of-Evidence approach. An LD50 > 2000 mg/kg bw was determined experimentally in rats for the source substances. Therefore, an acute oral LD50 > 2000 mg/kg bw is predicted for the target substance and is considered for the hazard assessment and classification and labelling. As explained in the analogue read-across justification, the differences in composition and molecular structure between the target and the source substances are unlikely to lead to differences in the acute oral toxicity.

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) studies from various source substances with similar structures and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological properties. The selected studies are 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 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 2) studies from various source substances with similar structures and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological properties. The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VIII, Section 8.5, in accordance with Annex XI, Section 1.5, of the REACH Regulation (EC) No. 1907/2006.

Additional information

No data on acute toxicity of isotridecanol, ethoxylated, < 2.5 EO (CAS No. 69011-36-5, EC No. 500-241-6) are available. In order to assess acute toxicity, studies performed with adequate source substances are considered in an analogue read-across approach in accordance with Annex XI, Section 1.5, of the REACH Regulation (EC) No. 1907/2006. The available source data allow for an accurate hazard assessment of the target substance. A detailed justification of the read-across approach is provided in IUCLID section 13.

Acute toxicity: oral

An acute oral toxicity study with isotridecanol, ethoxylated, 3-4 EO (CAS No. 69011-36-5) was conducted according to OECD guideline 423 under GLP conditions (BASF, 1999). Three Wistar rats per sex were dosed in a limit test at 2000 mg/kg bw in water. No mortality occurred during the observation period of at least 14 days. Clinical signs (ruffled fur, dyspnoea and sedation) were noted in 1/3females on Day 1. No clinical signs were observed during the observation period in any other animal. Under the conditions of this study, the LD50 value was found to be > 2000 mg/kg bw.

A second study addressing acute oral toxicity was conducted with isotridecanol, ethoxylated, 3 EO (CAS No. 69011-36-5) according to OECD guideline 401 (Sasol, 1986a). In this limit test, five Wistar rats per sex were exposed to a single dose of 10,000 mg/kg bw. No mortalities occurred during the 14 day-observation period. 1 h after application all animals showed piloerection and some of the animals also had diarrhoea. Later on the clinical signs comprised hunched posture, slowed movement, slight to moderate sedation and ataxia, staggering gait, temporarily ventral position, tremor, cramped and rigid posture and diuresis. Al clinical signs had ended within 72 h after application. Abnormal necropsy findings consisted of thickening of the glandular stomach mucosa, indicative of local irritation effects. The LD50 value was determined to be > 10,000 mg/kg bw.

To cover the lower end of the ethoxylation degree, an acute oral toxicity study with the alcohol 11-methyldodecan-1-ol (isotridecanol, CAS No. 27458-92-0, EC No. 248-469-2) was included as weight-of evidence data. The acute oral toxicity was evaluated in a reliable GLP-study conducted according to OECD guideline 423 (BASF, 2002). Three Wistar rats per sex received doses of 2000 mg/kg bw of the test substance in olive oil. No mortality occurred during the observation period of at least 14 days. 5 h after administration piloerection was observed in the male animals. No clinical signs were observed in the female animals. Under the conditions of this study, the LD50 value was found to be > 2000 mg/kg bw.

Acute toxicity: inhalation

No data on acute toxicity via the inhalation route of exposure are available for isotridecanol, ethoxylated, < 2.5 EO (CAS No. 69011-36-5, EC No. 500-241-6) as the inhalation route is considered less relevant than the dermal route.

Acute dermal toxicity

In a first study performed with alcohols, C12-13, ethoxylated, < 2.5 EO (CAS No. 66455-14-9, EC No. 500-165-3) according to OECD guideline 402 (Shell, 1979), four Wistar rats per sex and dose were used. Both sexes were dosed at 1000, 2000 and 4000 mg/kg bw under occlusive conditions for 24 h. Mortalities occurred at a dose level of 2000 mg/kg bw and above, resulting in a LD50 value of > 2000 mg/kg bw. Rats showed at all dose levels hyperactivity to stimuli. In the deceased, additional symptoms like lethargy, dyspnoea and greasy soiled fur and a progressive loss of body weight were observed.

In the second study conducted with 11-methyldodecan-1-ol (isotridecanol, CAS No. 27458-92-0, EC No. 248-469-2) and reported in a scientific publication (Smyth, 1962) the LD50 was determined by a method closely related to the one-day cuff method of Draize using groups of four male albino rabbits. The rabbits were exposed under occlusive conditions for 24 h. Information about the dose levels applied is not given in the publication but the LD50 value was determined to be 7.07 mL/kg bw corresponding to 5960 mg/kg bw considering a density of 843 g/L.

Conclusion

The available data indicate a very low level of acute oral and dermal toxicity for the source substances. In conclusion, low acute toxicity via the oral and dermal exposure route  is predicted for the target substance isotridecanol, ethoxylated, < 2.5 EO (CAS No. 69011-36-5, EC No. 500-241-6).

Justification for classification or non-classification

The available data on acute oral and dermal toxicity obtained with adequate structural analogue substances 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. Based on an analogue read-across (Weight-of-Evidence approach) considering structural analogue source substances, isotridecanol, ethoxylated, < 2.5 EO (CAS No. 69011-36-5, EC No. 500-241-6) is predicted not to fulfil the classification criteria and is consequently not classified for acute oral and dermal toxicity.

No information on acute toxicity via the inhalation route of exposure is available for isotridecanol, ethoxylated, < 2.5 EO (CAS No. 69011-36-5, EC No. 500-241-6) because the inhalation route is considered less relevant than the dermal route.