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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

LD50 (mice, 24h): 408 mg/kg for male and 419 mg/kg for female mice

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: abstracted from the summary published in the well-known publication
GLP compliance:
not specified
Species:
rat
Strain:
other: Sprague-Dawley
Sex:
not specified
Route of administration:
oral: unspecified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
600 mg/kg bw
Based on:
act. ingr.
Clinical signs:
other: Strong convulsions were observed before death. All of the rats had damage to the spleen
Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
an oral LD50 value of ca. 600 mg/kg was reported for Sprague-Dawley rats. Strong convulsions were observed before death. All of the rats had damage to the spleen.
Executive summary:

An oral LD50 value of ca. 600 mg/kg was reported for Sprague-Dawley rats. Strong convulsions were observed before death. All of the rats had damage to the spleen.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The key study was reported by Hans Riemann, 1950, where 200, 300, 400, 500 and 600 mg hydroxylamine hydrochloride /kg was administered to the male and female mice. Oral LD50 values reported for mice include 408 mg/kg for male and 419 mg/kg for female mice. In this study, adequate design and detailed information can fulfill the scientific principles, so the study should be given more weight for the determination of acute toxicity of test substance.

As the supportive study (Springer-Verlag, 1994), there are two summaries without detailed documented. After oral administration to rats, the LD50(rat) was 192 (± 52) mg/kg. And another oral LD50 value of ca. 600 mg/kg was reported for Sprague-Dawley rats. Strong convulsions were observed before death. All of the rats had damage to the spleen.

Another LD50of ≥127 mg/kg body weight was foundafter theintraperitoneal injectionroutein female CD1 mice, which is used to be a supportive information for acute toxicity ofhydroxylamine hydrochloride.

Justification for classification or non-classification

Based on the available data, Hydroxylamine hydrochloride can be classified as category 4 for the acute oral toxicity according to CLP (Regulation EC No. 1272/2008).