Hydroxylammonium chloride

Skin sensitisation

Administrative data

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

Data source

Reference

Reference Type:

publication

Title:

Toxicological Evaluations 6-Potential Health Hazards of Existing Chemicals-Hydroxylamine and its salts

Author:

Springer-Verlag, Berlin Heidelberg New York, London Paris Tokyo, Hong Kong Barcelona, Budapest

Year:

1994

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Hydroxylamine hydrochloride

IUPAC Name:

Hydroxylamine hydrochloride

Test material form:

not specified

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

No data

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

other: subcutaneous

Vehicle:

no data

Induction 2

Concentration / amount:

7 mg/kg, 13.5 mg/kg(subcutaneous);
3.5 mg/kg (intracardially);

Challenge

Challenge 1

Route:

other: intracardial

Vehicle:

no data

Challenge 2

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

Applicant's summary and conclusion

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.