Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
other:

Data source

Referenceopen allclose all

Title:
No information
Bibliographic source:
ATSDR (1999) U.S. Department of Health and Human Services Toxicological profile for formaldehyde Public Health Service. Agency for Toxic Substances and Disease Registry Division of Toxicology/Toxicology Information Branch 1600 Clifton Road NE, E-29
Title:
No information
Bibliographic source:
Haneke K (2002) Methylolurea [1000-82-4] Review of Toxicological Literature Integrated Laboratory Systems P.O. Box 13501 Research Triangle Park, North Carolina 27709 http://ntp-server.niehs.nih.gov/ntp/htdocs/Chem_Background/ExSumPdf/ Methylolurea2.pdf
Title:
No information
Bibliographic source:
OECD (1996) Urea, CAS No.: 57-13-6 OECD SIDS (Screening Information Data Set) UNEP Publications
Title:
No information
Bibliographic source:
OECD (2002) Formaldehyde, CAS 50-00-0 SIDS Initial Assessment Report for SIAM 14 UNEP Publication
Title:
No information
Bibliographic source:
Tyl RW, Ballantyne B, Fisher L, Fait D, Dodd D, Klonne D, Pritts I, Losco P (1995a) Evaluation of the developmental toxicity of ethylene glycol aerosol in CD-1 mice by nose-only exposure. Tox Sci 27: 49-62
Title:
No information
Bibliographic source:
Tyl RW, Ballantyne B, Fisher L, Fait D, Savine T, Dodd D, Klonne D, Pritts I (1995b) Evaluation of the developmental toxicity of ethylene glycol aerosol in the CD rat and CD-1 mouse by whole body exposure. Tox Sci 24: 57-75
Title:
No information
Bibliographic source:
US EPA (2002) Urea TRED, Federal Register: April 15, 2002 (Vol. 67, No. 72 http://epa.gov/oppsrrd1/REDs/urea_tred.htm
Title:
No information
Bibliographic source:
WHO (2002) IPCS (International Programme on Chemical Safety) Ethylene Glycol: Human Health Aspects: Concise International Chemical Assessment Document 45 http://www.inchem.org/documents/cicads/cicads/cicad45.htm#7.5

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion