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EC number: 208-011-4 | CAS number: 505-52-2
No skin irritation was observed in an acute dermal toxicity study (2000 mg/kg body weight)According the REACH Regulation column 2 in Annex VII “in vitro study for skin corrosion and in vivo study for skin irritation does not need to be conducted if an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg body weight).” Based on the read across to the source chemical dodecanedioic acid, which is classified as H319, causes serious eye irritation, the target chemical tridecanedioc acid is also classified as H 319.Serious eye damage/eye irritation: The substance tridecanedioic acid is classified as H319, causes serious eye irritation. Therefore a study on eye irritation is not foreseen according to Annex VII , Chapter 8.2 , column 2.
no effects on cornea
Iris, Observation time
The target substance tridecanedioic acid and its analogue dodecanedioic acid are both unsubstituted linear aliphatic dicarboxylic acids differing in chain length by only one methylene (CH2) group. The functional groups of both substances are identical, namely: carboxylic acid and methylene groups. There is no difference in their arrangement in the molecular structure. The only difference between source structure and target structure is an increase in the number of methylene groups from 10 to 11. Since already 10 methylene groups are present in the source structure, no qualitative change and no significant quantitative change in chemical and biological activities is to be expected upon adding one more methylene group. It is therefore suggested that read across can be performed for complex biochemical endpoints based on the close structural similarity between dodecanedioic acid and its analogue tridecanedioic acid.
In a primary eye irritation study 0.1 g of dodecanedioic acid was instilled into the conjunctival sac of the right eye of six male young adult White Russian rabbits. Animals then were observed for 13 days.
Cornea were not affected. Iris was very mild and reversibly affected. Chemosis and erythema were recorded for conjunctival effects, mean score (24 -72h) was 2.5 for iridal redness. Eyes were normal with 1 - 7 days. In this study, dodecanedioic acid was an eye irritant..
No skin irritation was observed in an acute dermal toxicity study (2000 mg/kg body weight) for tridecanedioic acid, therefore the substance is not irritating. Based on a read across to source chemical dodecanedioic acid, the substance tridecanedioic acid is classified as irritating to eyes.
The complete read across justification is attached as document.
Based on the available information in the dossier, the substance tridecanedioic acid (CAS No. 505-52-2) is classified for serious eye damage/eye irritation (Category 2; H319: Causes serious eye irritation) when considering the criteria outlined in Annex I of 1272/2008/EC.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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