Registration Dossier

Administrative data

Description of key information

No studies were located concerning the potential skin irritation or corrosion of hydroxylammonium nitrate. Hydroxylammonium sulphate, an analogue of the test chemical, was considered to be moderately irritating to the eyes of a rabbit.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no study available

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Insufficient details about the study design and results reported. Only one animal was used for testing purposes.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data.
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.1ml of hydroxylammonium sulphate.
Duration of treatment / exposure:
No data.
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
1
Details on study design:
No data.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: No effect
Irritant / corrosive response data:
Conjunctival redness of 3, conjunctival edema mean score of 1.3. Mean scores was determined from appearance at 24, 48 and 72 hours). Iritis (grade 1) was detected on day 1 only, no corneal response was observed. No conjunctival irritation was observed after 8 days.
Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Hydroxylammonium sulphate (0.1ml) is considered to be cause moderate eye irritation in rabbits resulting in conjunctival redness, conjunctival edema and iritis. Effects were resolved after 8 days.
Executive summary:

In a Draize eye irritation study, hydroxlammonium sulphate caused moderate eye irritation in rabbits after a single dose of 0.1 ml. Conjunctival redness, conjunctival edema and iritis were observed but had completly resolved after 8 days.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No specific studies were located regarding the potential for hydroxylammonium nitrate to cause irritation or corrosion. However studies located for the sensitization and repeated dose (dermal) toxicity indicate that the chemical may cause dermatitis. Hydroxylammonium sulphate, an analogue of hydroxylammonium nitrate, was found to cause moderate irritation to the eyes of a rabbit in a Draize test. However, although the study was conducted to a recognised protocol, only one rabbit was used in the study.


Justification for selection of eye irritation endpoint:
Only one study was located concerning the potential eye irritation of hydroxylammonium sulphate, an analogue of hydroxylammonium nitrate.

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

No studies were located to confirm the potential irritancy of the substance to skin, although studies located for the sensitisation study and repeated dose toxicity (dermal application) indicate that it can cause chronic and ulcerative dermatitis. Hydroxylammonium nitrate is classified as Skin Irrit 2 and Eye Irrit 2.