Registration Dossier
Registration Dossier
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EC number: 226-798-2 | CAS number: 5470-11-1
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well-conducted, detailed information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Guideline:
- other:
- Deviations:
- not specified
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- hydroxylamine hydrochloride
- IUPAC Name:
- hydroxylamine hydrochloride
- Test material form:
- not specified
- Details on test material:
- -source: purchased from either Sigma Chemical Co. (St. Louis, MO) or Aldrich Chemical Co. (Milwaukee, WI)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hr light/dark cycle
-Feed: pelleted food and tap waterad libitum
-Acclimation period: at least 2 weeks
Administration / exposure
- Route of administration:
- other: Intracoelomic
- Details on mating procedure:
- After an acclimation period of at least 2weeks, each female was mated randomly to one of two virile bucks of the same strain. The time of mating was observed by an investigator and designated as hour 0, day 0 of gestation.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2.66 mmol/embryo
Basis:
nominal conc.
Intracoelomic
- Control animals:
- yes, concurrent no treatment
Results and discussion
Results (fetuses)
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The test substance did not produce an early episode of embryonic cell death.
- Executive summary:
To investigate whether the hydroxylamine moiety is responsible for early cell death and, therefore, is likely to be associated with teratogenesis, five structurally related hydroxylamine-bearing chemicals(hydroxylamine hydrochloride, N-methylhydroxylamine
hydrochloride, hydroxyurea, acetohydroxamic acid, and hydroxyurethane) were administered at equimolar doses to rabbits either by subcutaneous (8.55 mmol/kg) or intracoelomic (2.66 mmol/embryo) injection on gestational day 12.
Cellular debris was obvious in forelimb buds from embryos treated with the hydroxylamine-bearing compounds; however, none of the amino compounds produced an early episode of embryonic cell death.
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