Registration Dossier

Administrative data

Description of key information

An OECD 407-study was conducted on the source substance 2-Hydroxypropane-1,2,3-tricarboxylic acid, tri (hexyl, octyl, decyl) ester. There was no indication that the substance was toxic in male or female rats after repeated oral exposure up to 1000 mg/kg bw/d.

It is expected that the result is valid for the target substance 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tris(C12-13-branched-alkyl) ester.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please see Analogue Justification
Reason / purpose:
read-across source
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
not examined
Key result
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no effects
Remarks on result:
other: no effects
Key result
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Klmisch 1

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
No long term study on the test substance 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tris(C12-13-branched-alkyl)esters exist. There was no indication that the source substance 2-Hydroxypropane-1,2,3-tricarboxylic acid, tri (hexyl, octyl, decyl) ester was toxic in male or female rats after repeated oral exposure up to 1000 mg/kg bw/d. It is likely that the same is valid for the test substance.

Justification for classification or non-classification

No classification based on long term effects is indicated according to the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.