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Toxicological information

Eye irritation

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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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
, see "Rationale for reliability" above
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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.