Carboxylic acids, C5-9, triesters with 2-ethyl-2-(hydroxymethyl)propane-1,3-diol

Endpoint summary

Description of key information

A NOAEL of 1000 mg/kg bw/d was determined for the test item based on effects observed in a combined repeated dose / reprotox screening test (OECD422).

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

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

There is one study available that assesses the possible toxic effect of the test substance after repeated oral dosing. The study was performed according to GLP and internationally accepted guidelines on the analogue TMP Pelargonate. The experimental procedures were based on the OECD guideline 422, in which both female and male rats were treated during 5 weeks. Three doses were tested (100, 300 and 1000 mg/kg bw/day) and compared to a control group that received the vehicle only.

No differences in body weights, food consumption or clinical signs were observed in treated animals compared to the control group. Next, no adverse findings were recorded in clinical pathology investigations (haematology, clinical chemistry and urine analysis) nor differences in the absolute and relative organ weights of treated animals were recorded. Also, no treatment-related changes were noted at macroscopic and microscopic observations.

Based on these results the NOAEL was considered to be the highest dose of 1000 mg/kg bw/day.

There are no test reports available that address the repeated dose toxicity of the test substance when exposure occurs via the inhalation or the dermal pathway. However, based on the results of the oral repeated dose toxicity study this is not deemed necessary.

Read-across justification

 From TMP Pelargonate CAS 127-57 -8

 ·Carbon number in Fatty Acids: C 9     

·Carbon number in Polyol: C6

·Total Carbons in Polyol Ester: C33     

·Molecular Weight:     554

 To Fatty Acids, C5 -9

 ·Carbon number in Fatty Acids: C5-9     

·Carbon number in Polyol: C6

·Total Carbons in Polyol Ester: C26 - C32   

·Molecular Weight: 400 - 540  

Both belong to the Trimethylolpropane (TMP) Esters as they have the trimethylolpropane group as a common structural part.

 

For both substances, it is valid to assume that when metabolism of these triesters takes place, this firstly leads to the generation of the corresponding fatty acids and of the polyol alcohol.

For substance “TMP Pelargonate" (CAS 127 -57 -8) this relates to trimethylolpropane and three C9 fatty chains.

For substance “TMP Fatty Acids, C5 -9” this also relates to trimethylolpropane and 3 C5-9 fatty chains.

As it is not expected that the acute toxicity is different between C5 and C9 fatty acid chains, read-across is considered justified.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:

Well documented study according to GLP and internationally accepted guidelines.

Justification for classification or non-classification

Based on the results of the repeated dose toxicity testing the test item should not be classified for repeated-dose toxicity or Specific Target Organ Toxicity following Repeated Exposure (STOT-RE) according to the criteria described in

Directive 67/548/EEC (Dangerous Substances Directive) and the EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) respectively.