Registration Dossier

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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
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.