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Toxicological information

Toxicity to reproduction: other studies

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Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted by Industrial Bio-Test Laboratories in 1977. This lab was investigated by the US EPA in 1978 and found to deliver study reports with questionable results. Mammalian toxicology studies conducted during the 1960's and until 1978 by Industrial Bio-Test Laboratories should therefore be used with great care. The OECD HPV programme has produced guidance on how to treat these studies. A study by Industrial Bio-Test Laboratories which has not been audited by EPA/FDA nor by Industry, should be rejected unless findings are consistent with a study conducted at a later date, in which case the study by Industrial Bio-Test Laboratories represents weak evidence. The present study was not audited, and no comparable study performed by another lab at a later date is available. Therefore the study is rejected as unreliable (reliability 3).

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Administration / exposure

Doses / concentrations
Remarks:
Doses / Concentrations:

Basis:

Results and discussion

Applicant's summary and conclusion