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Administrative data

Description of key information

In 2 valid studies  tetraethylammonium heptadecafluorooctanesulphonate  was tested for skin irritation/corrosion and eye irritation. The test substance was not irritating in both studies.

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

2 white New-Zealand rabbits were treated onto the inside of the ear with ca. 500 mg of the test substance. The test item remained under semiocclusion for 24 hours. Treated animals were inspected for skin effects (erythma, oedema) after removal of plaster and after 1, 4, 5 and 7 days. Total observation time was 7 days. The test substance was not irritating.

In a further study with the forunning (purity not specifed) of the test substance, tetraethylammonium heptadecafluorooctanesulphonate was also not irritating.

1 male and 1 female New Zealand white rabbit, 50 mg tetraethylammonium heptadecafluorooctanesulphonat was applied into the

conjunctival sac of one eye of each rabbit. The animals were observed for 7 days.

The test substance was not irritating (a slight reddening for a short term was caused by the test substance due to mechanical irritation).

Read-across justification

- Group: The perfluorooctane sulfonate anion (PFOS) does not have a specific CAS number. The acid and salts have the following CAS numbers: acid (1763-23-1), ammonium (NH4 +) salt (29081-56-9), potassium (K+) salt (2795-39-3), tetraethylammonium (C2H5)4N+) salt (56773-42-3).

For the registration of tetraethylammonium perfluorooctanesulfonate (CAS 56773-42-3) the data on perfluorooctane sulfonate anion (PFOS) as well as the respective salts were taken into consideration and a read across approach was used due to the following reasons:

- Justification: REACH regulation EC 1907/2006 and ECHA guidance document R.6 state that substances whose physico-chemical, toxicological and ecotoxicological properties are likely to be similar, or follow a regular pattern as a result of structural similarity, may be considered as a group / category of substances. Properties of PFOS are mainly determined by the length of the fluorinated tail and not by the nature of the functional group. PFOS and its salts are dissociated in aqueous media, substituted amines and the corresponding sulfonyl fluorid are hydrolysed in aqueous media to PFOS. Therefore these compounds are members of a large family of perfluoroalkyl sulfonate substances. According to OECD, 2002, (ENV/JM/RD(2002)17/FINAL) “perfluorinated compounds represent a very unique chemistry”, at least substances with equal numbers of perfluorinated carbon atoms and functional groups.

Thus, in accordance with OECD, 2002, grouping and read-across based on the length of the perfluorinated carbon structure with a sulfonate moiety is in principle possible. The criterion of structural similarity is fulfilled and all substances may be regarded as group with respect to chemical behaviour. This judgement is in line with and confirmed by the existing classification of perfluoroalkyl sulfonates in Europe: according Annex VI to Regulation (EC) No 1272/2008 for classification and labeling several perfluoroalkyl sulfonates are considered as a group/category and therefore identical hazard class/category codes, and hazard statement codes applies. The following substances/CAS number are mentioned explicitly in the regulation: perfluorooctane sulfonic acid/1763-23-1, potassium perfluorooctanesulfonate/ 2795-39-3, diethanolamine perfluorooctane sulfonate/70225-14-8, ammonium perfluorooctane sulfonate/29081-56-9, lithium perfluoroocane sulfonate/29457-72-5.

This approach also apply to tetraethylammonium perfluorooctanesulfonate, as the evaluation of the toxicological data of tetraethylammonium perfluorooctanesulfonate substantiate the membership of the substance to the group and the same hazard class and statement codes are valid.

Therefore based on the available data as well as on earlier judgements by e.g. OECD and within the EU classification a read across approach is justified.

Justification for classification or non-classification

skin irritation:

mean value for erythema = 0, mean value for oedema = 0

On the basis of this data a classification is not justified

eye irritation:

mean values for cornea opacity (0); mean values for iris inflammation 0);

mean values for conjunctivae reddening (1), mean values for conjunctivae swelling (0)

On the basis of this data a classification is not justified