Registration Dossier

Administrative data

Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Extrapolation from results of animal studies to humans for the endpoint male fertility.
Author:
BAuA
Year:
2003
Bibliographic source:
Forschungsbericht Fb 984
Reference Type:
publication
Title:
A retrospective analysis of the added value of the rat two-generation reproductive toxicity study versus the rat subchronic toxicity study.
Author:
Janer G, Hakkert BC, Piersma, AH, Vermeire T, Slob W
Year:
2007
Bibliographic source:
Reproductive Toxicol 24: 103-113
Reference Type:
publication
Title:
Some aspects relating to the evaluation of the effects of chemicals on male fertility.
Author:
Mangelsdorf I, Buschmann J, Orthen B
Year:
2003
Bibliographic source:
Reg Toxicol Pharmacol 37: 356-369
Reference Type:
other: US EPA TSCA 8(e) submission
Title:
Unnamed
Year:
1990
Report Date:
1967
Reference Type:
publication
Title:
2-DIETHYLAMINOETHANOL CAS N°:100-37-8, SIDS Initial Assessment Report For SIAM 15
Author:
OECD SIDS
Year:
2004
Bibliographic source:
UNEP Publications
Reference Type:
other: US EPA TSCA 8(e) submission
Title:
Unnamed
Year:
1966
Report Date:
1966
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990
Reference Type:
other: US EPA TSCA 8(e) submission
Title:
Unnamed
Year:
1990
Reference Type:
publication
Title:
Evaluation of the inhalation toxicity of diethylethanolamine (DEEA) in rats.
Author:
Hinz, JP et al.
Year:
1992
Bibliographic source:
Fundam. Appl. Toxicol. 18: 418-424

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion