Registration Dossier

Administrative data

Endpoint:
respiratory sensitisation
Remarks:
other: reviewed data
Type of information:
other: Summary evaluation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: summarized by SCOEL

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
SCOEL/REC/164 - Hydrazine - Recommentation from the Scientific Committee on occupational exposure limits
Author:
SCOEL (Scientific Committee on Occupational Exposure Levels)
Year:
2016
Bibliographic source:
SCOEL (Scientific Committee on Occupational Exposure Levels)
Report date:
2016
Reference Type:
publication
Title:
Reactive airways dysfunction syndrone (RADS): Persistent asthma syndrome after high level irritant exposure
Author:
Brooks SM, Weiss MA, Bernstein IL,
Year:
1985
Bibliographic source:
Chest 88, 376-384 cited in SCOEL 2009
Reference Type:
publication
Title:
Toxicity assessment of hydrazine fuels
Author:
Keller WC
Year:
1988
Bibliographic source:
Aviat Spyce Environm Med 59, 100-106 cited in SCOEL 2009
Reference Type:
review article or handbook
Title:
Other chemical substances causing occupational asthma in : Bernstein IL, Chan-yeung M. Malo JL, Bernstein DI (eds) Asthma in the workplace
Author:
Malo JL, Bernstein IL
Year:
1993
Bibliographic source:
marcel Dekker , New York, Basel, Hong Kong, 481-502 cited in SCOEL 2009
Reference Type:
publication
Title:
Long-term inhalation toxicity of hydrazine
Author:
Vernot EH, MacEwan JD, Brunner RH, Haun CC, Kinkead ER, Prentice DE, Hall A, Schmidt RE, Eason RL, Hubbard GB, Young JT
Year:
1985
Bibliographic source:
Fundam Appl Toxicol 5, 1050-1064 cited in SCOEL 2009

Materials and methods

Principles of method if other than guideline:
Reviewed data
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrazine
EC Number:
206-114-9
EC Name:
Hydrazine
Cas Number:
302-01-2
Molecular formula:
H4N2
IUPAC Name:
hydrazine
Details on test material:
reviewed data

Test animals

Species:
other: reviewed data
Strain:
other: reviewed data
Details on test animals or test system and environmental conditions:
reviewed data

Test system

Route of induction exposure:
other: reviewed data
Route of challenge exposure:
other: reviewed data
Vehicle:
other: reviewed data
Concentration:
reviewed data
No. of animals per dose:
reviewed data

Results and discussion

Results:
Despite numerous descriptions of irritative reactions of the respiratory passages to hydrazine in the literature, there is no evidence that hydrazine causes allergic reactions in the respiratory tract. Specific animal experiments are not available.

Any other information on results incl. tables

Despite numerous descriptions of irritative reactions of the respiratory passages to hydrazine in the literature, there is no evidence that hydrazine causes allergic reactions in the respiratory tract. Specific animal experiments are not available.

Applicant's summary and conclusion