Bis(4-chlorophenyl) sulphone

Eye irritation

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

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

Test material information

Constituent 1

Reference substance name:

Bis(4-chlorophenyl) sulphone

EC Number:

201-247-9

EC Name:

Bis(4-chlorophenyl) sulphone

Cas Number:

80-07-9

Molecular formula:

C12H8Cl2O2S

IUPAC Name:

1-chloro-4-(4-chlorobenzenesulfonyl)benzene

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 8 days

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 8 days

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 8 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

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.