2,2'-oxybis[5,5-dimethyl-1,3,2-dioxaphosphorinane] 2,2'-disulphide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-04-21 to 1989-04-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-oxybis[5,5-dimethyl-1,3,2-dioxaphosphorinane] 2,2'-disulphide

EC Number:

223-829-1

EC Name:

2,2'-oxybis[5,5-dimethyl-1,3,2-dioxaphosphorinane] 2,2'-disulphide

Cas Number:

4090-51-1

Molecular formula:

C10H20O5P2S2

IUPAC Name:

2,2'-oxybis(5,5-dimethyl-1,3,2-dioxaphosphinane) 2,2'-disulfide

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 2.4-2.7 kg
- Housing: individually in stainless steel cages
- Diet (ad libitum): Kliba 341, Batch 44/89 rabbit maintenance diet, Klingentalmühle, Kaiseraugst, Switzerland
- Water (ad libitum): tap water
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as internal control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

up to 72 h

Observation period (in vivo):

up to 72 h

Number of animals or in vitro replicates:

3 (1 male, 2 females)

Details on study design:

SCORING SYSTEM:
according to OECD 405 and EU B.5

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect observed at any time point

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects observed at any time point in any eye

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

3

Reversibility:

other: no effects observed

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed at any time point

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study the test substance was not irritating to the eyes of rabbits.

Executive summary:

The test substance was subject to an eye irritation test according to guidelines OECD 405 and EU B.5. 0,1 mL of the test item were instilled into the eyes of 3 rabbits and irritating effects were evaluated up to 72 h after application. The untreated eyes served as internal controls. No effects were observed. Under the conditions of the study the test substance was not irritating to the eyes of rabbits.