Registration Dossier

Administrative data

Description of key information

Skin, rabbit: not irritating
Eye, rabbit: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for read-across

Reliable data on the skin and eye irritation potential of tetradecyl stearate (CAS 17661-50-6) are not available. The assessment of acute toxicity 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.

Skin irritation

CAS 3687-46-5

Decyl oleate (CAS 3687-46-5) was tested for its skin irritation potential in a study similar to OECD 404 (Dufour, 1994). The shaved skin of 3 male rabbits was exposed to an undisclosed amount of undiluted test material for 4 hours under semi-occlusive conditions. 3/3 animals had very slight erythema (score 1) 1 hour after exposure ended. At the 24-hour reading time point 2/3 animals still had very slight erythema and 1/3 had well-defined erythema. The mean erythema scores (over 24, 48 and 72 h) were 1, 0.33 and 1.33. Very slight edema (score 1) was observed in 1/3 rabbits from the 1-hour- up to and including the 72-hour reading time point. All irritation reactions were completely reversible within 5 days.

CAS 3234-85-3

A skin irritation study was performed according to a protocol similar to OECD 404 with tetradecanoic acid, tetradecyl ester (CAS 3234-85-3) (Planchette, 1985). The test substance was applied to the shaved or shaved and abraded skin of 6 male rabbits and held under occlusive conditions for 24 hours. The reading time points were 24- and 72 hours after patch removal. 1/6 animals had slight erythema (score 1 of 4) on the intact skin at the 24-hour reading time point, which had cleared completely by the 72-hour reading time point. No other skin irritation effects were observed in any animals (6/6). 1/6 animals had slight erythema (score 1 of 4) at the 24-hour reading time point on the abraded skin site. The skin irritation had cleared within 48 hours. The limited irritation effects on the abraded skin indicate that the substance is not a skin irritant and the results are therefore considered to be valid for the skin irritation potential assessment.

CAS 17661-50-6

In a review publication by the Cosmetic Ingredient Review, a skin irritation study with tetradecyl sterate was briefly summarised (Elder, 1985b). The Draize protocol was used (Draize, 1944). An unknown amount of the test material was applied to the shaved and abraded skin of 3 rabbits under occlusive conditions for 24 hours. The skin irritation effects were scored 0 and 48 hours after the test substance was removed (24 and 72 hours after exposure started). No individual scores were reported but no irritation was observed in any rabbit at the shaved and abraded treated skin sites. Therefore the test substance has a very low potential for skin irritation. Due to the lack of original data and limited documentation, this study was considered insufficient for assessment.

Eye irritation

CAS 983803-87-3

The eye irritation potential of 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was evaluated in a study performed according to OECD 405 (Busschers, 1998). 0.1 mL was instilled into one eye of 3 rabbits and left without washing. Remains of the test substance were noted in the treated eye of 3/3 animals on Day 1, while remains were present on the outside of the eyelids on Day 2 in 1/3 animals. At the 1-hour reading time point 3/3 rabbits had slight conjunctivae (score 1, 1, 1), which was still present in 1/3 rabbits at the 24-hour reading time point. The effect had cleared completely within 48 hours. No other eye irritation effects were observed in any rabbit at any time point.

CAS 17661-50-6

In a review publication by the Cosmetic Ingredient Review, an eye irritation study with tetradecyl stearate was briefly summarised (Elder, 1985c). 0.1 g of the test substance was instilled into one eye of 3 rabbits. The eye irritation effects were observed 24, 48, 72, 92 h and 7 days post exposure. No individual scores were reported but at the 24-hour reading time point, 3/3 rabbits had slight redness (conjunctivae). The effect had cleared completely in all rabbits within 48 hours. This indicates that the irritation potential of the test substance is low. Due to the lack of original data and limited documentation, this study was considered insufficient for assessment.

Overall conclusion for skin and eye irritation

The reliable data available for the read-across analogue substances did not show any skin or eye irritation effects. Therefore,

tetradecyl stearate is not considered to be a skin irritant or an eye irritant.


Justification for selection of skin irritation / corrosion 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 eye irritation 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 skin and eye irritation 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.