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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Hydroxylammonium sulphate
IUPAC Name:
Hydroxylammonium sulphate
Test material form:
not specified
Details on test material:
No data

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data.

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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.

Applicant's summary and conclusion

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.