Registration Dossier
Registration Dossier
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EC number: 944-989-5 | CAS number: 2156592-46-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
According to the criteria listed in column 1 of Annex IX or X, this study is proposed if the 28-d or 90-d studies indicate adverse effects on reproductive organs or tissues. The structurally related substance Tri (hexyl, octyl, decyl) citrate caused no adverse effects in the subacute study. There is no evidence that the metabolites/structural related substances for example Acetyl Tributyl Citrate, citric acid, citrate salts or citrate esters cause reprotoxic or developmental effects. Furthermore the test substance is mainly used in cosmetics, therefore animal testing should be avoided according to the Cosmetic Regulations.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
According to the criteria listed in column 1 of Annex IX or X, this study is proposed if the 28-d or 90-d studies indicate adverse effects on reproductive organs or tissues. The structurally related substance Tri (hexyl, octyl, decyl) citrate caused no adverse effects in the subacute study. There is no evidence that the metabolites/structural related substances for example Acetyl Tributyl Citrate, citric acid, citrate salts or citrate esters cause reprotoxic or developmental effects.Furthermore the test substance is mainly used in cosmetics, therefore animal testing should be avoided according to the Cosmetic Regulations. Results on the test substance 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tris(C12 -13 -branched-alkyl) ester are not available but the analogue substance Acetyl Tributyl Citrate was tested. The substance has the same functional group, the citrate.
Results concerning the reproductive and developmental toxicity of the analogue substance Acetyl Tributyl Citrate were included in a 1 -year chronic oral toxicity study. In this study, groups of male and female mice and rats receiving oral doses of 50 or 250 mg/kg/d Acetyl Tributyl citrate were mated during the ninth month. No significant, test-substance-related effects on male gonads were noted in rats or mice. However, an authenticated difference in desquamatosed spermatogenic epithelium between 250 mg/kg/d dose groups (mice and rats) and controls was observed. It was also determined that both doses of Acetyl Tributyl Citrate did not induce embryotoxicity or effect the growth or development of the progeny. Despite of that it is an indication that also the test substance 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tris(C14-15-alkyl) esters does not induce reproductive or developmental effects.
International Journal of Toxicology, 21 (Suppl. 2): 1 -17, 2002, Final Report on the Safety Assessment of Acetyl Triethyl Citrate, Acetyl Tributyl Citrate, Acetyl Trihexyl Citrate, and Acetyl Trioctyl Citrate.
Short description of key
information:
According to the criteria listed
in column 1 of Annex IX or X, this study is proposed if the 28-d or 90-d
studies indicate adverse effects on reproductive organs or tissues. The
structurally related substance Tri (hexyl, octyl, decyl) citrate caused
no adverse effects in the subacute study. There is no evidence that the
metabolites/structural related substances for example Acetyl Tributyl
Citrate, citric acid, citrate salts or citrate esters cause reprotoxic
or developmental effects.Furthermore the test substance is mainly used
in cosmetics, therefore animal testing should be avoided according to
the Cosmetic Regulations. Results on the test substance
1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tris(C14-15-alkyl) esters
are not available but the analogue substance Acetyl Tributyl Citrate was
tested. The substance has the same functional group, the citrate.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No classification based on reproductive or developmental effects is indicated according to the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.
Additional information
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.
