Ammonium sulphite

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Comparable to guideline study reliable with restrictions - Draize scoring system slightly modified, but with no effect on the results. - Test procedure, housing conditions, purity and stability were missing in the report. - Overall, the study is still good enough documented in order to use the study for RA.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

, see "Rationale for reliability" above

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium sulphite

EC Number:

231-821-4

EC Name:

Sodium sulphite

Cas Number:

7757-83-7

IUPAC Name:

disodium sulfite

Details on test material:

- Name of test material (as cited in study report): Natriumsulfit aktiviert wasserfrei
- Chemical description: Sodium sulfit + 0.5% cobalt sulfate
- Molecular formula: Na2SO3 + 0.5% CoSO4 * 7H2O
- Physical state: Solid
No further information on the test material was stated.

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: Mean body weight of male rabbits: 2.78 kg; mean body weight of female rabbits = 3.36 kg
- Diet (e.g. ad libitum): SSNIFF of the company Intermast
no furthre information on the test animals was stated.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 162 mg of test item (equivalent to 0.1 ml bulk volume)
No further information on the amount/concentration applied was stated.

Duration of treatment / exposure:

No data

Observation period (in vivo):

Readings: 1 h, 24 h, 48 h, 72 h, 8 d after application

Number of animals or in vitro replicates:

Total: 6 rabbits (2 males/ 4 females)

Details on study design:

SCORING SYSTEM:
-Assessment: Modified Draize scoring system
Cornea/chemosis:
0 = not observed
1 = slight
2 = clear
3 = heavy
4 = very heavy
Conjunctival redness:
0 = normal
1 = slight intensified
2 = clear
3 = heavy
Iris:
1 = ciliar injection
2 = iritis
Area of opacity:
1 = > 0; < 1/4
2 = ≥ 1/4; < 1/2
3 = ≥ 1/2; < 3/4
4 = ≥ 3/4

Secretion:
0 = normal
1 = slightly increased
2 = clearly increased
3 = heavily increased

TOOL USED TO ASSESS SCORE: Fluorescein was used at the reading on Day 8 after application
No further information on the study design was stated.

Results and discussion

In vivo

Irritant / corrosive response data:

The follwoing observations wer made during the 1-hour observation:
Animal #1: Clear conjunctival redness and chemosis (Score 2); slight secretion; blood was seen
Animal #2: Clear conjunctival redness and chemosis (Score 2); clearly secretion; blood was seen
Animal #3: Clear conjunctival redness and chemosis (Score 2); slight secretion
Animal #4: Clear conjunctival redness and chemosis (Score 2); clearly secretion; blood was seen
Animal #5: Clear conjunctival redness (Score 2) and heavy chemosis; clearly secretion; blood was seen
Animal #6: Slight conjunctival redness (Score 1) and chemosis (Score 2); clearly secretion

Any other information on results incl. tables

Overall irritation/corrosion results:

Irritation parameter	Basis	Time point	Score	Max. score	Reversibility	Remarks
Cornea score	Mean animal #1	24, 48, and 72 hours	0	4
Iris score	Mean animal #1	24, 48, and 72 hours	0	2
Conjunctivae score	Mean animal #1	24, 48, and 72 hours	1.67	3	fully reversible within: 8 days
Chemosis score	Mean animal #1	24, 48, and 72 hours	0.33	4	fully reversible within: 48 hours
Cornea score	Mean animal #2	24, 48, and 72 hours	0	4		At 24 hours blood was observed.
Iris score	Mean animal #2	24, 48, and 72 hours	0	2
Conjunctivae score	Mean animal #2	24, 48, and 72 hours	0.67	3	fully reversible within: 48 hours
Chemosis score	Mean animal #2	24, 48, and 72 hours	0.67	4	fully reversible within: 48 hours
Cornea score	Mean animal #3	24, 48, and 72 hours	0	4
Iris score	Mean animal #3	24, 48, and 72 hours	0	2
Conjunctivae score	Mean animal #3	24, 48, and 72 hours	0.33	3	fully reversible within: 48 hours	Slight conjunctival redness was again observed on Day 8.
Chemosis score	Mean animal #3	24, 48, and 72 hours	0	4
Cornea score	Mean animal #4	24, 48, and 72 hours	0	4		At 24 hours blood was observed.
Iris score	Mean animal #4	24, 48, and 72 hours	0	2
Conjunctivae score	Mean animal #4	24, 48, and 72 hours	1.33	3	fully reversible within: 72 hours	Slight conjunctival redness was again observed on Day 8.
Chemosis score	Mean animal #4	24, 48, and 72 hours	0.33	4	fully reversible within: 48 hours
Cornea score	Mean animal #5	24, 48, and 72 hours	0	4
Iris score	Mean animal #5	24, 48, and 72 hours	0	2
Conjunctivae score	Mean animal #5	24, 48, and 72 hours	1.33	3
Chemosis score	Mean animal #5	24, 48, and 72 hours	1	4
Cornea score	Mean animal #6	24, 48, and 72 hours	0	4
Iris score	Mean animal #6	24, 48, and 72 hours	0	2
Conjunctivae score	Mean animal #6	24, 48, and 72 hours	0.33	3	fully reversible within: 48 hours
Chemosis score	Mean animal #6	24, 48, and 72 hours	0.67	4	fully reversible within: 48 hours

Animal	1	2	3	4	5	6
Animal No.	0163	0162	0185	0159	0841	014
Animal weight (kg)	3.44	3.47	3.49	3.02	3.16	2.40
Sex	female	female	female	female	male	male

Readings	Animal	Cornea		Iris	Conjunctivae			Signs
		Opacity	Area		Redness	Swelling	Discharge
24 hours	1	0	0	0	2	1	2
	2	0	0	0	2	2	2
	3	0	0	0	1	0	0
	4	0	0	0	2	1	1	Scar
	5	0	0	0	1	2	1
	6	0	0	0	1	2	2
48 hours	1	0	0	0	2	0	0
	2	0	0	0	0	0	0
	3	0	0	0	0	0	0
	4	0	0	0	2	0	0	Scar
	5	0	0	0	2	1	1
	6	0	0	0	0	0	0
72 hours	1	0	0	0	1	0	0
	2	0	0	0	0	0	0
	3	0	0	0	0	0	0
	4	0	0	0	0	0	0	Scar
	5	0	0	0	1	0	0
	6	0	0	0	0	0	0
8 days	1	0	0	0	0	0	0
	2	0	0	0	0	0	0
	3	0	0	0	1	0	0
	4	0	0	0	1	0	0	Scar
	5	0	0	0	0	0	0
	6	0	0	0	0	0	0
mean 24 - 72 h	1	0.0	0.0	0.0	1.7	0.3	0.7
	2	0.0	0.0	0.0	0.7	0.7	0.7
	3	0.0	0.0	0.0	0.3	0.0	0.0
	4	0.0	0.0	0.0	1.3	0.3	0.3
	5	0.0	0.0	0.0	1.3	1.0	0.7
	6	0.0	0.0	0.0	0.3	0.7	0.7
mean		0.0	0.0	0.0	0.9	0.5	0.5

Conjunctivae

Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris) - Vessels normal 0 - Vessels definitely injected above normal 1 - More diffuse, deeper crimson red, individual vessels not easily discernible 2

Chemosis - No swelling 0 - Any swelling above normal (includes nictitating memnbrane) 1 - Obvious swelling with partial eversion of lids 2

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Sodium sulphite is not an eye irritant.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as eye irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.