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Diss Factsheets

Toxicological information

Toxicity to reproduction: other studies

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Administrative data

toxicity to reproduction: other studies
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was not conducted to standardised guidelines, however it was well reported.

Data source

Reference Type:
Developmental toxicity of hydroxylamine: an example of a maternally mediated effect
DeSesso J.M., Goeringer G.C.
Bibliographic source:
Teratology and Industrial Health. 6(1):109-21

Materials and methods

Principles of method if other than guideline:
Rabbits were injected subcutaneously or intravenously with hydroxylamine hydrochloride at doses between 50 - 650 mg/kg on day 12 of gestation. Animals that were still alive after 30 hours were sacrificed.
In a secondary experiment, hydroxylamine hydrochloride (25 - 200 µg in 5 - 40 µl of saline) was administered via intracoelomic injections into the chorionic cavity of developing rabbit embryos. Surviving embryos were allowed to develop to full gestation. A secondary group of animals (and embryos) were co-administered an antioxidant propyl gallate and again allowed to develop to full gestation.
GLP compliance:
not specified
Type of method:
in vivo

Test material

Constituent 1
Reference substance name:
Hydroxylamine hydrochloride
Hydroxylamine hydrochloride
Test material form:
not specified
Details on test material:
No data.

Test animals

not specified
Details on test animals or test system and environmental conditions:
No data.

Administration / exposure

Route of administration:
other: Subcutaneous or intracoelomic injections into embryos
not specified
Details on exposure:
No data
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data.
Duration of treatment / exposure:
A single treatment followed by sacrifice between 5 - 8 hours.
Frequency of treatment:
A single treatment by either subcutaneous or intravenous injection to pregnant dams
Duration of test:
5 - 8 hours
Doses / concentrations
Doses / Concentrations:
50 - 650
nominal conc.
No. of animals per sex per dose:
No data.
Details on study design:
No data.
No data.

Results and discussion

Observed effects

All rabbits injected subcutanously exhibited sever cyanosis and at higher doses mortality occured (effect level not stated).

Applicant's summary and conclusion

Pregnant rabbits administered hydroylamine hydrochloride via subcutaneous or intravenous injection caused maternal toxicity from methemoglobinemia which resulted in embryolethality. A maternal LOAEL of 50 mg/kg can be derived.
Hydroxylamine hydrochloride administered directly to embryos caused malformations, lethality and reabsorptions. A fetal LOAEL of 25 µg can be derived based on embryo reabsorption.
Executive summary:

In a non-standardised developmental toxicity test pregnant rabbits administered hydroxylamine hydrochloride via subcutaneous or intravenous injection (50 - 650 mg/kg) on gestational day 12 displayed severe cyanosis from methemoglobinemia resulting in embryolethality. Hydroxylamine hydrochloride injected into the chorionic cavity of embryos caused malformations, lethality and reabsorptions. A maternal LOAEL of 50 mg/kg based on methemoglobinemia and fetal LOAEL of 25 mg/kg based on reabsorptions can be derived. This study is considered reliable with restrictions and therefore by this study design hydroxylamine hydrochloride is considered a developmental toxicant.