Registration Dossier
Registration Dossier
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EC number: 290-844-8 | CAS number: 90268-43-2
Carcinogenicity
Administrative data
Description of key information
Non carcinogen
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance Sulfosuccinate of lanolin alcohol is not classified as a carcinogen because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008:
- Category 1 (1A, 1B): known or presumed human carcinogen;
- Category 2: suspected human carcinogen
Based on available studies there is no evidence of a carcinogenic potential for the Sulfosuccinate of Lanoline Alcohol.
Additional information
This study is not required for the substance registration dossier with the tonnage band between 100-1000 tonnes.
It was added to complement the Genetic toxicity studies related to the sulfosuccinate portion of the Sulfosuccinate of Lanolin Alcohol substance.
Sulfosuccinate of Lanoline Alcohol is chemically a complex substance, and genetic toxicity in vitro studies available were performed on the Lanolin Alcohol part of the molecule.
For the Sulfosuccinic part no genetic toxicity studies are available, however the evidence of non-carcinogenicity property was assessed on
Dioctyl Sodium Sulfosuccinate (DSS) and reported in this section.
DSS was given to rats on diet in different concentration for 2 years. Surviving animals were sacrificed and subjected to necropsy after two years. Lung, heart, liver, spleen, pancreas, stomach, small intestine, kidney, adrenal and testes were sectioned in all instances and colon, thyroid, parathyroid, lymph nodes, leg bones, leg muscles, and bone marrow were sectioned in some (number not noted). There was no effect of DSS on food intake (despite a significantly less weight gain than controls).
Another test available would investigate the potential anticarcinogenic action on mice of Lanolin on three point, using various carcinogens (MC Methylcholantracene, DMBA 9,10- dimethyil-1,2- benzanthracene) emulsified in benzene, lanolin and liquid paraffin solvents:
a) dilution effect,
b) higher concentration of the carcinogen in lanolin the neoplastic response;
c )other non-volatile solvents would behave similarly to lanolin;
d) the effect should also be demonstrable with other carcinogens;
Diminution in carcinogenic potency was obtained by substituting liquid paraffin for lanolin as diluent, however, results are incompatible with the idea that the inhibitory effect of lanolin constitutes a specific anticarcinogenic action.
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