Hydroxylammonium chloride

Endpoint summary

Description of key information

Available data is insufficient to conclude whether hydroxylamine hydrochloride is a skin/eye irritant. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: 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

Species:

rabbit

Strain:

Vienna White

Type of coverage:

other: semi-occlusive and occlusive

Duration of treatment / exposure:

15 minutes (semi-occlusive);
20 hours (occlusive);

Observation period:

1 week

Number of animals:

2 rabbits

Conclusions:

No irritation was seen after exposure for 1 or 5 minutes, but after 15 minutes a slight mottled redness occurred which was reversible after 1 week. After a 20-hour exposure, similar findings were recorded which were again reversible after 1 week.

Executive summary:

An 80% aqueous preparation of hydroxylamine hydrochloride was applied to the clipped dorsal skin of 2 rabbits (White Viennese) for1，5 or 15 minutes (semi-occlusive) or 20 hours (occlusive). No irritation was seen after exposure for 1 or 5 minutes, but after 15 minutes a slight mottled redness occurred which was reversible after 1 week. After a 20-hour exposure, similar findings were recorded which were again reversible after 1 week.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The report published by Springer-Verlag,1994 gave the related information on skin/eye irritation.

Skin irritation:

No irritation was seen after exposure for 1 or 5 minutes, but after 15 minutes a slight mottled redness occurred which was reversible after 1 week. After a 20-hour exposure, similar findings were recorded which were again reversible after 1 week.

However, for the purpose of classification, effects should be produced following the application of a test substance for up to 4 hours. Thus, the available data is insufficient to conclude whether hydroxylamine hydrochloride is a skin irritant.

Eye irritation:

Marked oedema and severe clouding of the cornea with a greasy surface layer were evident 1 hour after the instillation of 50 mg into the conjunctival sac of the rabbit eye (2 animals). After 24 hours, oedema, marked clouding, ciliary injection and discharge were seen, and after 8 days marked oedema, marked clouding, iritis, ingrowing vessels and a staphyloma. For the entire period, a grey white discolouration of the conjunctiva and the nictitating membrane was present.

However, when an 8% solution of hydroxylamine hydrochloride was continually dropped into the conjunctival sac of the rabbit eye for 5 minutes, no damage to the cornea occurred. However after the same solution was dropped in for 30 minutes, extreme swelling of the conjunctiva was observed with mydriasis. The cornea was not clouded, but the next day it was cyanotic and severely oedematous.

In the case of evaluation on eyes irritation, only 2 animals were exposed to test substance and recovery period of 8 days was applied, rather than 21 days required in the classification criteria of eye irritation. Thus, available data is insufficient to determine whether eye damage will reverse within 21 days.

Based on the description above, available data is insufficient to determine whether hydroxylamine hydrochloride is a skin/eye irritant.

Justification for selection of skin irritation / corrosion endpoint:
only one study was available

Justification for classification or non-classification

Based on the available data, it is inconclusive to implement the classification for the skin/eye irritation.