4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl-12H-dibenzo[d,g][1,3,2]dioxaphosphocin

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-07-26 - 1988-08-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well-documented study conducted under GLP according to OECD guideline 404 on the registered substance itself without deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl-12H-dibenzo[d,g][1,3,2]dioxaphosphocin

EC Number:

277-633-6

EC Name:

4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl-12H-dibenzo[d,g][1,3,2]dioxaphosphocin

Cas Number:

73912-21-7

Molecular formula:

C27H35O3P

IUPAC Name:

7,13-dicyclohexyl-5,15-dimethyl-9,11-dioxa-10-phosphatricyclo[10.4.0.0³,⁸]hexadeca-1(12),3(8),4,6,13,15-hexaen-10-ol

Test material form:

other: solid

Details on test material:

- Name of test material (as cited in study report): 4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl-12Hdibenzo[d,g][1,3,2]dioxaphosphocin

Test animals / tissue source

Species:

rabbit

Strain:

other: HC:NZW Albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd.
- Age at study initiation: adult
- Weight at study initiation: 3.0 - 3.5 kg
- Housing: individually in wire cages Type III-high with bedding of dust-free wood granulates Type S 8/15 (Ssniff, Hoechst)
- Diet (e.g. ad libitum): Standard diet ssniff K 4 (Ssniff Spezialdiäten GmbH, Soest/Westfalen), ca. 100-120 g per animal and day, feeding once daily in the morning
- Water (e.g. ad libitum): tap water ad libitum from 7 am to 7 pm
- Acclimation period: min. 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2°C
- Humidity (%): ca. 50%
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12 / 12, from 6 am tp 6 pm, artificial light of ca. 27 Watt/m²

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: concurrent no treatment in the alternate eye of the same animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl (bulk volume) = ca. 40 mg

Duration of treatment / exposure:

24h

Observation period (in vivo):

21d

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 24h

SCORING SYSTEM: Draize / McDonald, Shadduck (aqueous humour)

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: 1h - 7d

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: 1h - 7d

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: 1h - 7d

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24h

Remarks on result:

other: 1h - 7d

Irritant / corrosive response data:

The test item is not an eye irritant.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Conclusions:

The study was conducted under GLP according to OECD guideline 405 on the registered substance itself without deviations. The method is to be considered scientifically reasonable. Hence, the results can be considered as reliable to assess the eye irritating properties of 12H-Dibenzo(d,g)(1,3,2)dioxaphosphocin, 4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl in rabbits. The substance did not provoke any relevant or persistent reactions in the eye. The cornea, iris and conjunctivae score were determined to be 0.0 (mean of all animals). In consequence, the substance does not need to be regarded as eye irritant according to Regulation (EC) 1272/2008.

Executive summary:

In a primary eye irritation study (OECD guideline 405), 100 µl ≙ ca. 40 mg 12H-Dibenzo(d,g)(1,3,2)dioxaphosphocin, 4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl (no vehicle) was instilled into the conjunctival sac of adult albino HC:NZW rabbits (3 males) for 24 hours. Eyes were washed with phys. saline. Animals then were observed for 7 days. Irritation was scored by the method of Draize.

The substance did not provoke any relevant or persistent reactions in the eye. The cornea, iris and conjunctivae score were determined to be 0.0 (mean of all animals).

In this study, 12H-Dibenzo(d,g)(1,3,2)dioxaphosphocin, 4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl is not an eye irritant.