6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental work was carried out between 10.11.1997 and 18.11.1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Performed according to GLP, OECD guidelines followed and no deviations reported

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ukanol DOP

IUPAC Name:

Ukanol DOP

Constituent 2

Reference substance name:

6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide

EC Number:

252-813-7

EC Name:

6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide

Cas Number:

35948-25-5

Molecular formula:

C12H9O2P

IUPAC Name:

6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Ukanol DOP
- Substance type: white powder
- Lot/batch No.: not supplied
- Storage condition of test material: Room temperature, darkness
- Other:
- Test article name for report: Ukanol DOP
- Test concentration: undiluted
- Arrival of test article: 06.11.1997
- Test article characterization (purity, solubility and stability etc.) was the responsibility of Sponsor according to available statement of 05.11.1997. The test article was labelled with the laboratory number of this study (Lab. No. 01438). The test result relates to the above mentioned test article supplied by Sponsor.

Test animals / tissue source

Species:

rabbit

Strain:

other: SPF albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Stock: Mol:Russian
- Source: Møllegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved
- Weight at study initiation: 2.1 - 2.4 kg
- Housing: The study took place in animal room No. 2. During a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 cm2) with perforated floor.
- Diet (e.g. ad libitum): A pelleted complete rabbit diet ''Altromin 2123'' from Altromin, D-32791 Lage, Lippe, was available ad libitum. Analyses for major nutritive components and relevant possible contaminants are performed regularly on the diet. Certificates of analysis are retained.
- Water (e.g. ad libitum): The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth. Analyses for relevant possible contaminants are performed regularly. Certificates of analysis are retained.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15 (relative humidity)
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 (Light was on from 06 to 18 h)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml of the test article

Duration of treatment / exposure:

Single application

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

Three females

Details on study design:

Testing procedure:

The day before testing both eyes of the animals were examined with a hand held inspection lamp fitted with white and UV-light and magnifying glass with 2 x magnification to ensure there were no defects or irritation. The examination was performed before and after instillation of Fluorescein. Only the left eye was treated. The right eye remained untreated and served as control.

0.1 ml of the test article was placed in the left eye of the rabbits by gently pulling the lower lid away from the eyeball to form a cup into which the article was dropped. The lids were then gently held together for 1 second. The eyes were examined and the grade of ocular reaction was recorded 1 and 24 hours later. After the first 24 hour reading Fluorescein was instilled. After rinsing with 20 ml 0.9% sodium chloride solution the eyes were examined again using UV-light to detect possible corneal damage. The eyes were also examined 48 and 72 hours as well as 7 days after the treatment. The reactions were scored according to the grades for ocular lesions outlined in the attached report.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72h

Score:

0.8

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 72h

Score:

1.1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Any other information on results incl. tables

The individual results are shown in Table 1 of attached report.

 

- One hour after application of the test article all three rabbits showed diffuse redness of conjunctivae and discharge with moistening of lids and hairs and considerable area around the eye.

- After 24 hours animal No. 1002 showed slight opacity of cornea on less than the half of the area. With Fluorescein all animals showed slight opacity of cornea on less than the half of the area. Diffuse redness of conjunctivae and discharge with moistening of lids and hairs and considerable area around the eye were observed in all animals. Slight swelling of conjunctivae was observed in animal Nos. 1000 and 1002, whereas animal No. 1004 showed obvious swelling of conjunctivae.

- After 48 hours all animals showed slight opacity of cornea on less than the half of the area. With Fluorescein all animals showed slight opacity of cornea on less than a quarter of the area. Diffuse redness and slight swelling of conjunctivae were observed in all animals. Animal Nos. 1000 and 1002 showed discharge with moistening of lids and hairs and considerable area around the eye, animal No. 1004 showed discharge of lids and hairs just adjacent to lids.

- After 72 hours animal No. 1000 showed slight opacity of cornea on less than the half of the area. With Fluorescein all animals showed no comeal reactions. Furthermore all animals showed diffuse redness and slight swelling of conjunctivae as well as discharge of lids and hairs just adjacent to lids.

- After 7 days no eye reactions due to the application of the test article were seen.

The following mean values were obtained from the data presented in Table 1 of attached report:

cornea opacity                                  0.8

iris lesion                                          0.0

redness of conjunctiva                    2.0

oedema of conjunctiva (chemosis) 1.1

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: According to the directive of the EEC commission 93/21/EEC of April 27, 1993

Conclusions:

According to the directive of the EEC commission 93/21/EEC of April 27, 1993 no classification is required for eye irritation for Ukanol DOP.

Executive summary:

The eye irritant effect of Ukanol DOP was investigated according to the method recommended in the OECD Guideline No. 405, “Acute Eye Irritation/Corrosion”, Feb. 1987, and EEC Guideline B.5 “Acute Toxicity (Eye Irritation)”, 29.12.1992.

Three female albino rabbits were exposed to 0.1 ml of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours as well as 7 days after dosing.

 

Moderate signs of eye irritation were observed among the rabbits.

The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated:

 

                                                 Ukanol DOP

cornea opacity                                  0.8

iris lesion                                          0.0

redness of conjunctiva                     2.0

oedema of conjunctiva (chemosis) 1.1

 

According to the directive of the EEC commission 93/21 /EEC of April 27, 1993 no classification is required for eye irritation of Ukanol DOP.