Hydroxylammonium chloride

Carcinogenicity

Description of key information

There is no evidence of increasing the incidence of cancer that induced by Hydroxylamine hydrochloride.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records

Reference

Endpoint:

carcinogenicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: abstracted from the summary published in the well-known publication

Qualifier:

no guideline followed

GLP compliance:

no

Species:

mouse

Strain:

other: 78 male AKR mice, 60 female C3H mice and 85 male Swiss mice

Sex:

male/female

Details on test animals or test system and environmental conditions:

78 male AKR mice, 60 female C3H mice and 85 male Swiss mice

Route of administration:

oral: feed

Vehicle:

not specified

Details on exposure:

given pelleted feed to which 1 or 2% by weight of hydroxylamine hydrochloride

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

entire lifetime

Remarks:

Doses / Concentrations:
1 or 2% by weight of hydroxylamine hydrochloride
Basis:
nominal in diet

Control animals:

yes, plain diet

Details on study design:

In a long-term study, a total of 78 male AKR mice, 60 female C3H mice and 85 male Swiss mice were given pelleted feed to which 1 or 2% by weight of hydroxylamine hydrochloride had been added. Treatment continued for their entire lifetime.

Clinical signs:

effects observed, treatment-related

Mortality:

mortality observed, treatment-related

Details on results:

While tumours developed in most C3H controls (no further details), there was a considerable reduction in the spontaneous tumour incidence in the group treated with 2% of the hydrochloride (0% after 15 months compared with 20% in the controls). In the AKR mice the treatment led to a dose-dependent increase in survival time. A positive influence on the survival time was also established in the C3H mice given 1% by weight. In the male Swiss mice no relevant effects were found in either dose group.

Relevance of carcinogenic effects / potential:

No substance-induced tumours were observed in any of the mouse strains.

Dose descriptor:

NOAEL

Remarks on result:

not determinable

Remarks:

no NOAEL identified

Conclusions:

No substance-induced tumours were observed in any of the mouse strains during the test period.

Executive summary:

In a long-term study, a total of 78 male AKR mice, 60 female C3H mice and 85 male Swiss mice were given pelleted feed to which 1 or 2% by weight of hydroxylamine hydrochloride had been added. Treatment continued for their entire lifetime. While tumours developed in most C3H controls (no further details), there was a considerable reduction in the spontaneous tumour incidence in the group treated with 2% of the hydrochloride (0% after 15 months compared with 20% in the controls). In the AKR mice the treatment led to a dose-dependent increase in survival time. A positive influ­ence on the survival time was also established in the C3H mice given 1% by weight. In the male Swiss mice no relevant effects were found in either dose group. No substance-induced tumours were observed in any of the mouse strains

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Carcinogenicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Carcinogenicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available data, Hydroxylamine hydrochloride cannot cause the increase of cancer incidence. Thus, it cannot be classified according to CLP (EC No. 1272/2008).

Additional information

In vivo study was reported by Springer-verlag, 1994. In this long-term study, no substance-induced tumours were observed in any of the mouse strains during the test period.

In vitro carcinogenesis assays utilizing an attachment indepencence endpoint was conducted by Karl A. Traul and K. Takayama; 1980, which showed that Hydroxylamine hydrochloride clearly gave a positive response.

In generally, data in vivo should be given more weight as it gave high relevance to human exposure and more reliability was presented. Therefore, it is reasonable to conclude that Hydroxylamine hydrochloride has no positive potential of increasing the cancer incidence.

Justification for selection of carcinogenicity via oral route endpoint:
Available data in vivo should be given more weight as its high relevance and reliability.