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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
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to OECD guideline with acceptable restrictions (analytical purity of the test substance not reported, only 8 days observation period, application of solid test substance without rinsing)

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:
analytical purity of the test substance not reported, only 8 days observation period, application of solid test substance without rinsing
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: 4,4'-dichlorodiphenyl sulfone (DCDPS)
- Analytical purity: not reported

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Fa. Gaukler, Offenbach, Germany
- Mean weight at study initiation: 3.56 kg (males)
- Housing: individual, in stainless steel cages
- Diet: SSNIFF G/K standard diet for rabbits, 4 mm; Fa. SSNIFF-Versuchsdiäten GmbH, Soest, Germany; approx. 130 g/animal/day
- Water: 250 mL/animal/day
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-26 °C
- Humidity: 50-80 %
- Photoperiod: 12 hours dark / 12 hours light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 78 mg of pure, grained, solid test substance.
Duration of treatment / exposure:
Single application in the conjunctival sac, the eyes were kept unwashed.
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM: Draize


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Slight corneal opacity, slight iritis and moderate to strong conjunctivitis were observed until 72 hours (3/3 animals), slight corneal opacity (1/3 animals) and slight conjunctival redness (3/3 animals) was still persistent on day 8.
Other effects:
Scars, miosis (3/3 animals at 48 h) and suppuration (max. 2/3 animals at 48 h) were noted during the observation period. On day 8, only scars were noted (3/3 animals).

Any other information on results incl. tables

Observation

period

Animal number

Draize score

Symptoms

Cornea

Iris

Conjunctivae

Chemosis

24 h

1

1

1

2

2

scar

2

1

1

2

2

3

1

1

2

2

48 h

1

1

1

2

2

scar/pc

2

1

1

2

2

scar/pc

3

1

1

2

2

scar/pc/s

72 h

1

1

1

2

2

scar/pc

2

1

1

2

2

scar

3

1

1

2

2

scar/pc/s

8 days

1

1

0

1

0

scar

2

0

0

1

0

scar

3

0

0

1

0

scar

Mean

(24-48-72 h)

1

1

1

2

2

2

1

1

2

2

3

1

1

2

2

pc: pupil constriction; s: suppuration

Applicant's summary and conclusion

Conclusions:
DCDPS is irritating to the eye.
Executive summary:

In an eye irritation study (BASF AG, 1981), 0.78 mg of solid, grained DCDPS was instilled into the conjunctival sac of one eye of young adult Vienna White rabbits (3 males). No washing of the eye was performed. Animals then were observed for 8 days and effects of the single treatment were scored by the method of Draize at 24, 48 and 72 hours and on day 8. In all tested animals, the mean cornea score and the mean iris score were each 1, while the mean conjunctivae score and the mean chemosis score were each 2. At the end of the observation period, chemosis and iris effects had resolved. Cornea and conjunctivae effects were not fully reversible, but showed a clear tendency towards reversibility. Although, slight scar formation was noted in all test animals at the 48 -hour and subsequent readings. This effect together with the reddening of the conjunctivae are indicative for mechanical distress caused by the solid nearly unsoluble test sustance in the unwashed eyes. Therefore these observations can not be considered as relelevant for classification and the result of the assay can be identified as irritant at the most.