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Toxicological information

Carcinogenicity

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Administrative data

Description of key information

rats, oral in diet: negative; rats, subcutaneous: negative (Umeda 1956 / cited in WHO report 1974) 
rats, oral in diet: negative (Nothdurft 1961)

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Study duration:
chronic
Species:
rat
Quality of whole database:
All available studies pre-date GLP and OECD testing guidelines. Insufficient details are available.

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Species:
rat
Quality of whole database:
All available studies pre-date GLP and OECD testing guidelines. Insufficient details are available.

Additional information

There are three tests which examined the carcinogenic potential of the test substance, but data is either only available from a secondary source or it is not reported in the detail currently demanded by OECD testing guidelines (Nothdurft 1961).

In the first study 21 rats were fed with 0.1% of the test substance (no data on purity) in the diet for 184 days. The animals were checked for tumours and no increased tumour incidence was observed. 8 rats which survived for more than 400 days (432-683) showed no abnormalities (Umeda 1956, cited in WHO report 1974).

Additionally, 12 rats received monthly subcutaneous injections of an aqueous suspension of the test substance (2 mL of 2.5% suspension; no data on purity) for their whole lives. No tumours were seen at the site of injection (Umeda 1956, cited in WHO report 1974).

In the third test by Nothdurft (1961) which was cited in the WHO report of 1974 rats received the test substance (no data on purity) at 0.1% and 1% in their diet. The increase in tumour incidence was observed over their life-span. 11 animals died before the end of the experiment in the 1% group. No increase of the tumour incidence occurred compared to historical controls. No data of the 0.1% group was available.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC):

The available data does not give rise of concern for carcinogenicity.

As a result the substance is not considered to be classified for carcinogenicity under Directive 67/548/EEC.

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

The available data does not give rise of concern for carcinogenicity.

As a result the substance is not considered to be classified for carcinogenicity under Regulation (EC) No. 1272/2008.