3,9-bis(2,4-di-tert-butylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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)

Version / remarks:

adopted 1981

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3,9-bis(2,4-di-tert-butylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

EC Number:

247-952-5

EC Name:

3,9-bis(2,4-di-tert-butylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Cas Number:

26741-53-7

Molecular formula:

C33H50O6P2

IUPAC Name:

3,9-bis(2,4-di-tert-butylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

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 - 2.5 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration (if solution): undiluted

Duration of treatment / exposure:

Eyes not washed out

Observation period (in vivo):

1-, 24-, 48- and 72 hours

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to OECD Guideline 405

TOOL USED TO ASSESS SCORE: hand-slit lamp and diagnostic-lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animals

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animals

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

3 animals

Time point:

other: 24, 48, 72 hours

Score:

0.53

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animals

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

After 1 hour of treatment a redness and chemosis score of 2 was found in all animals. After 24 hours the chemosis was fully reversible and a mean conjunctival redness score of 1.3 (2/1/1) was found. After 48 hours only one animal showed a conjunctival redness score of 1 which was reversed after 72 hours. In the area of application no discoloration of the cornea and conjunctivae was observed which could be related to effects of the test article. No corrosion was observed at each of the measuring intervals.

Other effects:

No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. The body weight gain of all rabbits was similar.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met