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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Studies in animals

Three separate animal tests have been conducted for the read-across substance, sodium hypochlorite (reviewed by EU, 2007b). Based on the behaviour and the composition of the target substance, the read-across data from the analogue inorganic bleaching agent were used to evaluate sensitisation potential of the Halo Salt (see read-across justification in IUCLID section 13).

In the first study a solution of sodium hypochlorite (8.0%) was administered undiluted at induction and as 3.2% solution at challenge in guinea pigs. There was no observed test substance related contact hypersensitivity in the test group.

Two separate guinea pig sensitisation studies were conducted to mixtures of sodium hypochlorite and different surfactants. A 50:50 (v/v) mixture of a sodium hypochlorite solution and surfactant was tested in one study and a mixture (50:50 v/v) of sodium hypochlorite and another surfactant was tested in the other study. The concentration of sodium hypochlorite in the test substance was in both cases 4.5 %. During induction, 4.5%, 3.35%, 2.25%, and 1.1% hypochlorite were patched. 2.25% hypochlorite was used during challenge. There were no differences in skin alteration between test and control groups upon challenge, therefore both studies did not show any potential to cause delayed contact hypersensitivity for hypochlorite.

Studies in humans

Two sensitisation tests (Patch tests) have been conducted on human volunteers with hypochlorite (reviewed by EU, 2000b). A first test was performed on 86 and the other test on 90 volunteers. Sodium hypochlorite solutions (0.034% and 0.076%) caused acceptable level of irritation during both screening and main tests. In the first test there was no evidence of sensitisation observed on 86 volunteers upon challenge. In the second test, at challenge, one individual gave some evidence of sensitisation. This subject also reacted to another product patched in an adjacent site and a challenge on the same above mentioned other test article would be necessary to confirm the nature of this reaction.

Reports from dermatological case studies indicate that there have been a few isolated cases of allergic contact sensitization (EU, 2007b). However, these isolated cases are poorly reported and not fully conclusive. Rare cases of hypersensitivity are usually preceded by either long-term or exaggerated skin exposure to hypochlorite. Given the widespread use of sodium hypochlorite, the likelihood of allergic contact sensitization due to sodium hypochlorite in practice is negligible.

In conclusion, based on the information on skin sensitisation potential of the read-across substance (sodium hypochlorite) it is concluded that Halo Salt is not expected to cause any sensitisation by skin contact.


Migrated from Short description of key information:
Due to corrosivity of the Halo Salt a skin sensitisation test is not required. Three earlier conducted animal studies for read-across substance, sodium hypochlorite, do not show potential for sensitisation. Also standard sensitisation studies in human volunteers do not indicate a potential for hypochlorite to induce contact sensitisation. In dermatological case studies there have been reports indicating a few cases of allergic contact sensitisation. However, these reports are of poor quality and the documentation is not sufficient for assessment. Based on the results of these studies from read-across substance it is concluded that Halo Salt does not pose a skin sensitisation hazard.

Justification for selection of skin sensitisation endpoint:
No single study was selected. The conclusion is based on the literature review of the studies conducted for the read-across substance, sodium hypochlorite.

Justification for classification or non-classification

Halo Salt is not considered to be skin sensitising and therefore, has not to be classified according to the CLP Regulation No. 1272/2008 and according to EU Directive 67/548/EEC.