Registration Dossier
Registration Dossier
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EC number: 231-982-0 | CAS number: 7783-18-8
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:
One reliable animal study, according to OECD guideline429 (Skin Sensitisation: Local Lymph Node Assay, modified according to Ehlings et al. 2005)and according to GLP has been performed for ammonium thiosulfate which shows that the test item has no sensitising properties.
The positive control group caused the expected increases in lymph node cell count (S.I.: 1.986) and lymph node weight (statistically significant at p ≤ 0.01). Therefore, the study is regarded as valid. The stimulation index for lymph node weight was 1.844 and for ear weight 1.198.
Migrated from Short description of key information:
Ammonium thiosulphate did not reveal any sensitising properties in the local lymph node assay (modified OECD 429, method according to Ehlings et al. 2005). Thus, ammonium thiosulphate does not require classification as sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Migrated from Short description of key information:
There is no evidence on specific respiratory hypersensitivity in test animals following acute inhalation exposure with ammonium thiosulphate.
Justification for classification or non-classification
Skin Sensitisation:
The reference Haferkorn (2010) is considered as the key study on skin sensitisation and will be used for classification. The overall sensitisation results are as follows:
Local lymph node assay (LLNA) in mice
SIs of less than 1.4 (0.546 - 0.940) were observed for lymph node cell count at all test concentrations of ammonium thiosulphate (10, 25, 50 %) and no dose response could be observed..
In addition, SIs of less than 1.1 (0.977 - 1.038) were observed for ear weight at all concentrations of ammonium thiosulphate (10, 25, 50 %).
Thus, the classification criteria acc. to Directive 67/548/EEC and Regulation (EC) 1272/2008 as skin sensitizer are not met.
Respiratory sensitisation
There is no evidence on specific respiratory hypersensitivity in humans following repeated inhalation exposure to ammonium thiosulphate. Furthermore, none of the repeated dose toxicity studies via inhalation reports respiratory hypersensitivity in the test animals. Thus, the classification criteria acc. to Directive 67/548/EEC and Regulation (EC) 1272/2008 as respiratory sensitiser are not met.
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