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Diss Factsheets

Toxicological information

Eye irritation

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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:
guideline study with acceptable restrictions
Remarks:
Deviations with no effect on the results: - Purity and stability were not stated. - A slightly modified scoring system was used. The naming of the scale of scoring was different, but otherwise the scoring of chemosis/cornea was from 0-4; conjunctivae redness from 0-3 and iris was from 0-2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
, see "rational for reliability"
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium disulphite
EC Number:
231-673-0
EC Name:
Disodium disulphite
Cas Number:
7681-57-4
Molecular formula:
Na2S2O5
IUPAC Name:
disodium disulphite
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): disodium disulphite
-Test substance No.: 84/200

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: GAUKLER; D-6050 OFFENBACH / MAIN, FRG
- Weight at study initiation: Mean weight 2.48 kg (males; one male 2.51 kg and the other male 2.44 kg), 2.40 kg (female)
- Housing: Individually in cages made of stainless steel with wire mesh walk floors; floor area: 40x51 cm; No bedding in the cages; Sawdust in the waste trays
- Diet: Ovator Solikanin 4mm, Muskator-Werke, D-4000 Duesseldorf-1, Germany; about 130 g/animal/day
- Water (e.g. ad libitum): Tap water; about 250 ml/animal/day
- Acclimation period: At least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 -24 °C
- Relative humidity: 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 / 12
No further information on the test animals was stated.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (ca. 107 mg of the comminuted test substance) to the conjunctival sac of the right eyelid.
No further information on the amount/concentration applied was stated.
Duration of treatment / exposure:
one application
Observation period (in vivo):
8 days; Readings at 1, 24, 48, 72 hours and on day 8 after application
Number of animals or in vitro replicates:
2 males / 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
The test substance was not washed out.

SCORING SYSTEM:
SCALE FOR SCORING OCULAR LESIONS:
CHEMOSIS (SW) AND CORNEA (OP)
(OPACITY-DEGREE OF DENSITY) :
0 = NONE
1 = SLIGHT
2 = WELL-DEFINED
3 = SEVERE
4 = VERY SEVERE

CONJUNCTIVAE REDNESS (RED) :
0 = NORMAL
1 = SLIGHT
2 = WELL-DEFINED
3 = SEVERE

IRIS :
0 = NORMAL
1 = CIRCUM-CORNEAL INJECTION
2 = IRITIS
No further information on the study design was stated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
not reversible
Remarks:
in 8 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks:
in 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
aniaml #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
not reversible
Remarks:
in 8 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks:
in 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
During the 1-hour reading slight corneal opacity was seen in one animal. Also, at the 1-hour observation well-defined conjunctivae redness and severe chemosis were observed in all animals. At the 1-hour reading detachment of the cornea was seen in one male.
At the 24-hour and 48-hour readings suppuration was seen in all rabbits.
At the 72-hour reading suppuration and contracted pupils were observed in the female and one male.
On day 8 contracted pupils, detachment of the cornea, small retractions in the eyelids and marginal vascularization of the cornea were observed in the female rabbit.
On day 8 detachment of the cornea, small retractions in the eyelids, marginal vascularization of the cornea and pannus were observed in one male rabbit. The other male rabbit was free of ocular effects on day 8.
It was observed that the cornal opacitiy worsened in two animals by day 8. It changed from slight opacity to well-defined opacitiy. Also, it was observed that the well-defined conjunctival redness in two animals, which was seen at the 1, 24, 48, and 72 hours- readdings, was still seen on the last day of observations. The chemosis disappeared in one animal completely by day 8. In the two remaining animals the chemosis became better, but was still seen on day 8.
For the raw data please refer to "Any other information on results incl. tables" below.

Any other information on results incl. tables

Results:

Readings Animal Cornea Iris Conjunctival Symptoms
Erythema  Chemosis
1h 1 0 0 2 3  
2 0 0 2 3  
3 1 0 2 3 DC
24 h 1 0 0 2 3 S
2 0 1 2 2 S
3 0 0 2 3 S
48 h 1 1 0 2 2 S
2 1 1 2 2 S
3 1 0 2 2 S
72 h 1 1 0 2 2 S/PC
2 0 0 2 1  
3 1 0 2 2 S/PC
8 d 1 2 0 2 1 PC/DC/RE/MV
2 0 0 0 0  
3 2 0 2 1 DC/RE/MV/PA
mean 24 - 72 h 1 0.7 0 2 2.3  
2 0.3 0.7 2 1.7  
3 0.7 0 2 2.3  
mean 1 0.6 0.2 2 2.1  

DC - Detachment of the cornea

MV - Marginal vascularization of the cornea

PC - Pupil contracted

PA - Pannus

RE - Small retraction in the eyelid

S - Suppuration

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is as Category 1 (H319).