Registration Dossier

Administrative data

Description of key information

Skin Irritation
RA-S, CAS 68424-31-7, Key, Robinson, 1991, Croda, Skin irr., RL2 – not irritating
Danish EPA, QSAR prediction skin irritation, 2010, RL2
Eye Irritation
RA-S, CAS 68424-31-7, Key, Robinson, 1991, Croda, Eye irr., RL2 – not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

There were no studies conducted for the Fatty Acid Polyol with the CAS No. 15834-04-5 (2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl divalerate), therefore data from studies of structural analogues, conducted according to OECD Guideline 404 (skin irritation/corrosion) and OECD Guideline 405 (eye irritation), were used for read-across.

 

Skin Irritation

Fatty acids, C5-10, esters with pentaerythritol (CAS No. 68424-31-7) were tested for skin irritation potential according to OECD Guideline 404 (RA-S, CAS 68424 -31 -7, Key, Robinson, 1991, Croda, Skin irr., RL2): The shaved left flank of three female New Zealand White rabbits was exposed to 0.5 mL test material for 4 hours under semi-occlusive conditions. Thereafter, the rabbits were observed for 4 d after exposure and skin reactions were assessed using the Draize scheme periodically (1 hour after application and on days 1, 2, 3 and 4) after removal of the test substance. Very slight to well-defined erythema were observed up to three days after application and very slight to slight edema was observed only one day after application, respectively. All signs regressed and no signs of erythema or edema were evident thereafter.

Furthermore, the result of an acute dermal toxicity study which was conducted according to OECD 402 (RA-S, CAS 131459-39-7, Key, Croda, Allen, 1999, acute dermal, rat, RL2) can be used for risk evaluation of the irritation potential and supports the view that a non-classification of fatty acid polyol esters with short chain length of the fatty acids is warranted for skin irritation. This fatty acid polyol is composed of C5 -C9 fatty acids with pentaerythritol. A single dose of 2000 mg/kg bw of the test material was applied on the shaved skin of five Spraque-Dawley rats for 24 h under semiocclusive conditions and, in addition to mortality and systemic effects, the skin reactions were observed for up to 14 days after exposure. None of the animals showed any signs of skin reaction (erythema/edema/scale) after exposure to this limit dose.

In addition to the experimental data presented above, a (Q)SAR- prediction performed by the Danish Environmental Protection Agency and Danish QSAR group, National Food Institute, Technical University of Denmark (DTU) was available.According to the OASIS Database, CAS No. 15834 -04 -5 was predicted to have no skin irritation potential (Danish EPA, QSAR prediction skin irritation, 2010, RL2).

Taken all results together, all available results for skin irritation confirm that a non classifiaction is warranted.

 

Eye Irritation

Fatty acids, C5-10, esters with pentaerythritol (CAS No. 68424-31-7) were tested for eye irritation potential according to OECD Guideline 405 (RA-S, CAS 68424-31-7, Key, Robinson, 1991, Croda, eye irr., RL2): 0.1 mL of the test material was instilled into the conjunctival sac of one eye of three New Zealand White rabbits. Animals were observed for 72 hours. Irritation was scored 24, 48 and 72 hours after instillation according to the method of Draize. No corneal or iridial effects were observed. Conjunctival effects included slight redness (one animal) and slight discharge (one animal) were transiently seen approx. one hour after dosing but were completely reversible within the first 24 h.

Justification for classification or non-classification

According to the DSD and CLP criteria for classification and labelling of dangerous substances CAS No. 15834-04-5 (2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl divalerate) is not classified as skin or eye irritant.