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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Remarks:
in vivo
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
Qualifier:
according to guideline
Guideline:
other:
Deviations:
not specified
Principles of method if other than guideline:
The test Guinea-pigs were each given 7 mg/kg (corresponding to about 1/10 of the absolute lethal dose) subcutaneously 3 times at intervals of 12 days. A second group of 6 guinea-pigs was given subcutaneous injections of 13.5 mg/kg (equivalent to 1/4 of the absolute lethal dose) 5 times at intervals of 6 days.
GLP compliance:
not specified
Type of study:
not specified
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data
Route:
other: subcutaneous
Vehicle:
no data
Concentration / amount:
7 mg/kg, 13.5 mg/kg(subcutaneous);
3.5 mg/kg (intracardially);
Route:
other: intracardial
Vehicle:
no data
Concentration / amount:
7 mg/kg, 13.5 mg/kg(subcutaneous);
3.5 mg/kg (intracardially);
No. of animals per dose:
6 guinea-pigs per dose
Details on study design:
No data
Challenge controls:
No data
Positive control substance(s):
not specified
Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The authors concluded from this that hydroxylamine hydrochloride had a sensitizing effect.
Executive summary:

The possible sensitizing effect of hydroxylamine hydrochloride on guinea-pigs after subcutaneous pre-treatment and intracardial challenge was studied. 6-Guinea-pigs were each given 7 mg/kg (corresponding to about 1/10 of the absolute lethal dose) subcutaneously 3 times at intervals of 12 days. A second group of 6 guinea-pigs was given subcutaneous injections of 13.5 mg/kg (equivalent to 1/4 of the absolute lethal dose) 5 times at intervals of 6 days. The treatment was tolerated without signs of toxicity. 12 days after the last subcutaneous injection the animals in the first group were given an intracardial injection of 3.5 mg hydroxylamine hydrochloride (1/20 of the absolute lethal dose). Similarly, those in the second group were injected with 3.5 mg/kg intracardially 6 days after the last subcutaneous injection. 4 of the 12 guinea-pigs died 15 to 20 minutes after the intracardial injection. The remaining animals were restless, shook their heads, scratched themselves, were breathless and suffered convulsions. 4 Guinea pigs had urinary and faecal discharges 1 to 2 minutes after the injection. The same intracardial dose of 3.5 mg hydroxylamine hydrochloride/kg was tolerated without signs of toxicity by 2 control animals. The authors concluded from this that hydroxylamine hydrochloride had a sensitizing effect.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Only one study was available. In this publication, there is only summary without details described.The possible sensitizing effect of hydroxylamine hydrochloride on guinea-pigs after subcutaneous pre-treatment and intracardial challenge was studied.However, only clinic sign was described, while skin effects were not provided. Based on the results given in this report, it is insufficient to conclude whether test substance is a sensitizer.


Migrated from Short description of key information:
Available data is insufficient to conclude the sensitisation of hydroxylamine hydrochloride.

Justification for selection of skin sensitisation endpoint:
only one study was available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the availalbe data, it is inconclusive to make the classification for the sensitization of hydroxylamine hydrochloride.