Registration Dossier

Administrative data

Description of key information

Oral: LD50 > 2000 mg/kg bw 
Dermal: LD50 > 2000 mg/kg bw
Inhalation: no data

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises adequate, reliable (Klimisch score 2) 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).

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
Quality of whole database:
The available information comprises adequate, reliable (Klimisch score 2) 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).

Additional information

Justification for read-across

Reliable data on the acute oral, inhalation and dermal toxicity of tetradecyl stearate (CAS 17661-50-6) are not available. The assessment of acute toxicity by the oral and dermal route was therefore based on studies conducted with analogue substances 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) and within Chapter 5.1 of the CSR.

Acute oral toxicity

CAS 3687-46-5

An acute oral toxicity study (limit test) was performed with decyl oleate (CAS 3687-46-5), according to a protocol similar to OECD 401 (Dufour, 1994). 5 female NMRI EOPS mice received a single dose of 2000 mg/kg bw by gavage. There were no mortalities. No signs of clinical toxicity were reported during the 6-day study period and there was no effect on the body weights. No necropsy was performed. The acute oral LD50 in mice was found to be > 2000 mg/kg bw.

A study was performed by Gloxhuber (1967) according to a protocol similar to OECD 401, and reported in a summary with limited information. 10 male rats received approximately 17000 mg/kg bw (19.9 mL/kg bw) decyl oleate by gavage (Gloxhuber, 1967). No mortality occurred during the 14-day observation period. Increased respiratory rate, ruffled fur and light diarrhoea were observed in the animals after dosing, for an unknown length of time. The body weight was not affected. The LD50 is considered to be > 17000 mg/kg bw. 

CAS 3234-85-3

A study was performed by Cade (1976) according to a protocol similar to OECD 401, and reported in a summary with limited information. 5 rats/sex/dose were administered 5000 mg/kg bw tetradecanoic acid, tetradecyl ester (CAS 3234-85-3) as a 50% solution in corn oil by gavage. One male died on Day 4 of an undisclosed cause. No clinical signs were observed during the 14-day observation period and the body weight gain was within the expected range for this strain and study type. No unusual findings were reported during the macroscopic examination. The oral LD50 is considered to be > 5000 mg/kg bw.

Acute dermal toxicity

CAS 3687-46-5

An acute dermal toxicity study (limit test) was performed with decyl oleate (CAS 3687-46-5) according to OECD Guideline 402 (Beerens-Heijnen, 2010). 2000 mg/kg bw of the test substance was applied to the skin of 5 Wistar rats/sex/dose under an occlusive dressing for 24 hours. No mortality occurred. Piloerection and/or chromodacryorrhoea were noted in all males on Day 1 and/or 2. No clinical signs were noted in females. The body weight increases were within the range expected for rats used in this type of study and no treatment-related findings were reported during the necropsy and histopathological examination. Erythema was observed on the treated skin for up to 4 days during the first week in 3/5 females. Scales or scabs were noted on the treated skin area in 5/5 females and 3/5 males for up to 9 days during Day 7-15 of the observation period. The LD50 is considered to be > 2000 mg/kg bw.

CAS 93803-87-3

The potential acute dermal toxicity of 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was assessed in a study (limit test) performed according to a protocol similar to OECD Guideline 402 (Busschers, 1998). 2000 mg/kg bw of the test substance was applied to the skin of 5 Wistar rats/sex/dose under an occlusive dressing for 24 hours. No mortality occurred. No toxicologically relevant clinical signs were noted during the 14-day observation period. The body weight increases were within the range expected for rats used in this type of study and no treatment-related findings were reported during the necropsy and histopathological examination. The LD50 is considered to be > 2000 mg/kg bw.

CAS 17661-50-6

In a review publication by the Cosmetic Ingredient Review, an acute oral toxicity study was briefly summarised (Elder, 1985a).

Tetradecyl stearate in corn oil at doses of 5000 mg/kg bw and 10000 mg/kg bw were administered to 5 and 20 mouse, respectively, by gavage. There was no mortality or clinical signs of toxicity observed during the study period. Hence the LD value was determined to be >10000 mg/kg bw. Due to the lack of original data and limited documentation, this study was considered insufficient for assessment.

Overall conclusion for acute toxicity

The reliable data available for the read-across analogue substances indicate a very low level of acute toxicity following the oral and dermal route, as LD50 values were greater than the currently applied limit values. Therefore, as the available data did not identify any hazard for acute toxicity, tetradecyl stearate (CAS 17661-50-6) is not considered to be hazardous following acute exposure.


Justification for selection of acute toxicity – oral endpoint
Hazard assessment is conducted by means of read-across from structural analogues. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between the source and target substances and overall quality assessment (refer to the endpoint discussion for further details).

Justification for selection of acute toxicity – dermal endpoint
Hazard assessment is conducted by means of read-across from structural analogues. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between the source and target substances and overall quality assessment (refer to the endpoint discussion for further details).

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 tetradecyl stearate (CAS 17661-50-6) data will be generated from data for 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 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.