Registration Dossier

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: see 'Remark'
Remarks:
Comparable to guideline study reliable with restrictions Minor deviations with no effect on the results: - Purity and stability of the test substance were no 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:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
,see "rational for reliability"
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dipotassium disulphite
- Test substance No.: 84/201
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; D-6050 OFFENBACH / MAIN, FRG
- Weight at study initiation: 2.46 kg (male), mean 2.57 kg (females; one female 2.62 kg and the other female 2.51 kg)
- Housing: Individually in cages made of stainless steel with wire mesh walk floors, floor area: 40 x 51 cm; No bedding in the cages; Sawdust in the waste trays.
- Diet: OVATOR SOLIKANIN 4 MM; MUSKATOR-WERKE D-4000 DUESSELDORF-1, FRG (ABOUT 130 G/ANIMAL/DAY )
- Water: About 250 ml tap water/animal/day
- Acclimation period: At least 8 d

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 (about 114 mg of the comminuted test substance) was administered into the conjucntival sac of the right eyelid. The untreated eye served as control.
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:
1 male / 2 females
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):
O= 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 = NORMA L
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:
other: 24, 48, and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
not reversible
Remarks:
in 8 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks:
in 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
in 8 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
not reversible
Remarks:
in 8 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24,48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24,48, and 72 hours
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks:
in 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
in 8 days
Irritant / corrosive response data:
During the 1-hour reading slight corneal opacity was seen in one animal. Also, at the 1-hour reading well-defined conjunctival redness and severe chemosis were observed in all animals. Detachment of the cornea and discharge of blood were observed in one male at the 1-hour reading.
At the 24-hour reading suppuration in two animals was observed.
At the 48 hour reading suppuration was observed in all animals.
At the 72 hour reading suppuration was observed in one male and suppuration, small retractions in the eyelids, and pupil contration were observed in one female.
On day 8, the corneal opacitiy worsened in all animals. The conjunctival redness (well-defined) remained the same throughout the observation period, except for one animal in which slight conjunctival redness was observed on day 8.
The chemosis was not fully reversed in any of the animals on day 8, but became better.
On day 8 marginal vascularization of the cornea and small retractions in the eyelids were observed in one female. In addition, marginal vascularization of the cornea was observed in the male rabbit. Furthermore, marginal vascularization of the cornea, small retractions in the eyelids, suppuration, and pupil contration were observed in the remaining female
For raw data see "Any other information on the results incl. tables" below.

Any other information on results incl. tables

Results:

Readings Animal cornea Iris conjunctiva Symptons
opacity area redness swelling discharge
1 h 1 0 0 0 2 3 2  
2 1 2 0 2 3 2 DC/DB
3 0 0 0 2 3 2  
24 h 1 0 0 0 2 3 2 S
2 1 2 0 2 2 2 S
3 0 0 0 2 2 2  
48 h 1 1 3 0 2 2 1 S
2 1 3 0 2 2 2 S
3 1 2 0 1 1 1 S
72 h 1 1 2 0 2 1 0  
2 1 3 1 2 2 1 S
3 1 3 0 2 2 1 S/RE/PC
8 h 1 2 2 0 2 1 0 MV/RE
2 1 2 0 1 1 0 MV
3 2 3 0 2 2 1 S/RE/PC/MV
mean 24 - 72 h 1 0.7 1.7 0.0 2.0 2.0 1.0  
2 1.0 2.7 0.3 2.0 2.0 1.7  
3 0.7 1.7 0.0 1.7 1.7 1.3  
mean   0.8 2.0 0.1 1.9 1.9 1.3  

DC - DETACHMENT OF THE CORNEA

DB - DISCHARGE OF BLOOD

MV - MARGINAL VASCULARIZATION OF THE CORNEA

PC - PUPIL CONTRACTED

RE - SMALL RETRACTIONS IN THE EYELIDS

S - SUPPURATION

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is classified as irritating (Classification: risk of serious damage to eyes).
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is as Category 1.
Classification: risk of serious damage to eyes