Decanoic acid, monoester with glycerol

Endpoint summary

Description of key information

Oral (read-across OECD 423): LD50 > 2000 mg/kg bw

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)

Remarks:

Summary of available data used for the endpoint assessment of the target substance

Adequacy of study:

key study

Justification for type of information:

refer to analogue justification provided in IUCLID 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

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Source: CAS 91052-13-0

Additional data are available on the following source substances:

CAS 142-18-7:

LD50 (m/f, rat) > 20000 mg/kg bw

CAS 73398-61-5:

LD50 (f, mouse) > 23625 mg/kg bw

Interpretation of results:

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

Conclusions:

The read-across application is justified in the analogue justification. Based on the available data, the target and source substances are considered not to show differences in acute oral toxicity. The LD50 oral was > 2000 mg/kg bw for all source substances; therefore the target substance is expected to show a very low level of 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, reliable (Klimisch score 1 and 2) and consistent studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, ecotoxicological and toxicological profile (refer to the endpoint discussion for further details). The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of 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

Read-across justification

Data on the acute dermal toxicity of Esterification product of glycerol and C8-C12 (even numbered) fatty acids (old CAS 26402-22-2) are not available. The assessment of acute dermal toxicity was therefore based on a study conducted with a source substance as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

Acute oral toxicity

CAS 91052-13-0

The acute oral toxicity of Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates, was assessed in a study performed according to OECD guideline 423 and under GLP conditions (Key, 2010). A total of 3 female Wistar rats were exposed to a limit dose of 2000 mg/kg bw in a stepwise procedure (3 rats per step). No mortality was observed up to the end of the 14-day observation period. Hunched posture and/or piloerection were noted in all females on Day 1 of the observation period. All animals showed the expected gain in body weights during the study and necropsy revealed no substance-related findings. Based on the results, the oral LD50 value for female Sprague Dawley rats is > 2000 mg/kg bw. In accordance with OECD guideline 423, the oral LD50 cut-off of the test substance is considered to be 5000 mg/kg bw.

CAS 142-18-7

The acute oral toxicity of 2,3-dihydroxypropyl laurate was investigated in Wistar rats according to the national FDA guideline "Appraisal of the safety of chemicals in foods, drugs and cosmetics" (Key, 1977). In this experiment, 2 groups of 5 animals per sex and dose were administered the test material in the vehicle (corn oil) by gavage at doses of 10,000 and 20,000 mg/kg bw, respectively. One of the 5 males and 1/5 female treated with 20,000 mg/kg bw died 48 h after test substance administration. No mortality was observed at 10,000 mg/kg bw during the 7-day observation period. At both dose levels, slight staggering, ataxia and piloerection were observed 1 and 3 h post-administration (number of animals not specified). The observed clinical signs were reversible within 24 h. Body weight gains were reduced in the surviving males and females of the 20,000 mg/kg bw group from Day 0 to Day 7. This effect was mainly attributed to a strong decrease in body weight in 1/4 males and 1/4 females at study termination (ca. -11 and -28%, respectively). The body weight gain of the remaining 3 animals per sex ranged from 4 to 7% (males) and 10 to 19% (females). The body weight gain of male and female animals treated with 10,000 mg/kg bw was within the normal range for this species and strain. The mean group body weight gain was about 14 and 18% for males and females, respectively. Necropsy revealed no substance-related findings in the examined organs (brain, lung, heart, stomach, intestine, liver, spleen, kidneys, serous membrane/vessels, lymph nodes and gonads). Based on the results, the oral LD50 value for male and female Wistar rats is > 20,000 mg/kg bw.

CAS 73398-61-5

The acute oral toxicity of Triglycerides, mixed decanoyl and octanoyl was investigated in Tyler's Original Strain mice in an early study similar to OECD guideline 401 (Key, 1977). Ten female animals per dose were gavaged with the undiluted test substance at volumes of 12.5, 20 and 25 mL/kg bw, which were equivalent to doses of 11,812.5, 18,900 and 23,625 mg/kg bw as calculated from a density of 0.945 g/mL. Mortality was observed within 24-48 h in animals receiving the test substance at 20 and 25 mL/kg bw (number of dead animals not reported). Ataxia, lethargy, dyspnoea and diuresis were observed within 15 min of treatment. Complete loss of activity was observed in several animals within 2 h after administration, although other individuals were found to become more active at this time. All survivors appeared asymptomatic from Day 3 up to the end of the study period. Some individuals showed a slight loss in body weight at Day 7. Based on these results, the oral LD50 value for female Tyler's Original Strain mice was determined to be > 23,625 mg/kg bw.

Overall conclusion for acute toxicity

The reliable data available for the three source substances indicate a very low level of acute oral toxicity, as LD50 values were greater than the currently applied limit values. The LC50 value was the maximum attainable concentration. Therefore, as the available data did not identify any hazard for acute toxicity, Esterification product of glycerol and C8-C12 (even numbered) fatty acids is not expected to be hazardous following acute exposure.

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Esterification product of glycerol and C8-C12 (even numbered) fatty acids (no CAS) data will be generated from information available on reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

Therefore, based on the analogue read-across approach, the available data on acute toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.