Registration Dossier

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.