Registration Dossier
Registration Dossier
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EC number: 914-103-1 | CAS number: -
Endpoint summary
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:
- Based
on the available information on absorption, distribution, metabolism and
excretion properties as well as the available toxicological data of all
three components of the reaction mass, it can be concluded, that ammonium
sulphate is the most critical substance within the reaction mass. There
is, however, no information available on the skin sensitising potential of
ammonium sulphate. Thus, read-across is conducted from the structurally
related substance ammonium chloride (CAS 12125-02-9) based on an analogue
approach (a detailed justification for the analogue approach is provided
as attachment in IUCLID Section 13).
The
skin sensitisation potential of ammonium chloride was evaluated in a study
performed according to GLP and guideline EPA 540/9-82-025 (Hoechst, 1987).
Twenty Pirbright-White guinea pigs received an intracutaneous induction
with 5% ammonium sulphate. 8 days later, a second induction with a
concentration of 25% by an occlusive epicutaneous application which was
held in place for 48 h was performed. Eleven days after the second
induction, the animals were challenged by an application of 0.5 mL of an
aqueous solution containing 10% ammonium sulphate under occlusive
conditions for 24 h. The readings 24 and 48 h after removal of the
occlusive dressing revealed that 2 of 20 animals showed very slight,
hardly perceptible erythema. Thus, the criterion for a positive test
result (positive reactions in 30% of animals) is not fulfilled. Therefore,
ammonium chloride can be regarded as not sensitising to skin.
Migrated from Short description of key information:
Based on the read-across data from ammonium chloride (CAS 12125-02-9), the reaction mass of ammonium sulphate and potassium sulfate and sodium sulphate is expected to be not skin sensitising.
Justification for classification or non-classification
Based on read-across, the available data on the skin sensitising potential of the reaction mass of ammonium sulphate and potassium sulfate and sodium sulphate are conclusive but not sufficient for classification according to the criteria of Directive 67/548/EEC (DSD) and Regulation 1272/2008/EC (CLP).
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