Hydroxylamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

; 50 mm3 (one sharp-edged spoon) of test material applied (OECD0.1 ml,< 100 mg); 2 animals were used (OECD: 1-3); the eyes were not washed out after 24 h (OECD: washing after 24 h); observation period was 3 days (OECD: 21); exam. using fluorescein

Principles of method if other than guideline:

BASF-Test:
Before OECD guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. Usually approximately 50 µl or one sharp-edged spoon in case of solids of the test substance were applied to the conjunctival sac of one eye of 2 animals. The non- or saline- treated eye served as control. In studies with solids, talcum powder was alternatively used as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days.
The eyes were not washed out after 24 h as specified in OECD Guideline 405, which could be critical for solids which thus remained on the cornea for several days, causing mechanical damage. Probably, this would have been less severe if it had been washed out after 1 day.

GLP compliance:

no

Remarks:

; GLP was not compulsory at the time the study was conducted.

Test material

Test material information

Constituent 1

Reference substance name:

Bis(hydroxylammonium) sulphate

EC Number:

233-118-8

EC Name:

Bis(hydroxylammonium) sulphate

Cas Number:

10039-54-0

IUPAC Name:

bis(hydroxyammonium) sulfate

Details on test material:

- Name of test material (as cited in study report): Hydroxylammoniumsulfat
- Analytical purity: pure grade

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: animal 1: 2.22 kg; animal 2: 2.12 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the second eye of the same rabbit was treated with 50 mg talcum powder.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: one sharp-edged spoon of the test substance, undiluted; ca. 50 mg

Duration of treatment / exposure:

24 h; the substance was not washed out.

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2 males

Details on study design:

One sharp-edged spoon of the undiluted, solid test substance was applied to the right conjuntival sac of one male and one female Vienna White rabbit. The left eye, treated with talcum powder, served as a control. The substance was not washed out.
Ocular reactions were recorded after 10 min, 1, 3 and 24 hours, as well as 48 and 72 h after instillation using a BASF-scoring system, which is convertible into the current OECD Draize scheme. For the evaluation the BASF scores given in the raw data were converted to Draize scores. The reading time points used for assessment were 24, 48 and 72 hours after application.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Any other information on results incl. tables

Table 1: Scores for eye irritation effects in the treated eyes as well as in the control eyes

Reading time point	Animal 1, treated eye (right)
	Cornea	Iris	Conjunctivae redness	Conjunctivae chemosis	Additional findings
10 min	0	0	1	0
1 h	0	0	1	1
3 h	1	0	2	2
24 h	1	0	1	2
48 h	0	0	1	0
72 h	0	0	0	0
Reading time point	Animal 1, control eye (left)
	Cornea	Iris	Conjunctivae redness	Conjunctivae chemosis	Additional findings
10 min	0	0	1	0
1 h	0	0	1	0
3 h	0	0	1	0
24 h	0	0	1	0
48 h	0	0	0	0
72 h	0	0	0	0
Reading time point	Animal 2, treated eye (right)
	Cornea	Iris	Conjunctivae redness	Conjunctivae chemosis	Additional findings
10 min	0	0	1	0
1 h	0	0	1	1
3 h	0	0	1	2
24 h	1	0	1	1
48 h	0	0	1	0
72 h	0	0	0	0
6 d	0	0	0	0
8 d	0	0	0	0
Reading time point	Animal 2, control eye (left)
	Cornea	Iris	Conjunctivae redness	Conjunctivae chemosis	Additional findings
10 min	0	0	1	0	substance residues
1 h	0	0	1	0	substance residues
3 h	0	0	1	0	substance residues
24 h	0	0	1	0
48 h	0	0	0	0
72 h	0	0	0	0
6 d	0	0	0	0
8 d	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS