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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The experimental work was carried out between 10.11.1997 and 14.11.1997.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Performed to GLP, OECD Guideline 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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ukanol DOP (HCA)

IUPAC Name:

Ukanol DOP (HCA)

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
- Physical state: White powder
- Lot/batch No.: Not supplied
- Storage condition of test material: Room temperature, darkness
- Other:
-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. 01437). The test result relates to the above mentioned test article supplied by Sponsor.

Test animals

Species:

rabbit

Strain:

other: SPF albino rabbits

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Stock Mol:Russian from Møllegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved. The animals were earmarked on arrival.
- Weight at study initiation: 2.3 - 2.6 kg
- Housing: The study took place in animal room No. 2 provided with filtered air at a temperature of 20°C ± 3°C, relative humidity of 55% ± 15% and air changes 10 times/hour. The room was illuminated to give a cycle of 12 hours light and 12 hours darkness. Light was on from 06 to 18 h. 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
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): The room was illuminated to give a cycle of 12 hours light and 12 hours darkness. Light was on from 06 to 18 h.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL undiluted

Duration of treatment / exposure:

Exposure time: 4 hours

Observation period:

1 hour, 24, 48 and 72 hours after the termination of the exposure

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: To each of two 16-layer gauze patches (2.5 x 2.5 cm) 0.5 ml of the test article was applied
- % coverage: No details provided in report
- Type of wrap if used: To each of two 16-layer gauze patches (2.5 x 2.5 cm) 0.5 ml of the test article was applied, and the patches were placed on the appropriate test site on the back of each rabbit. The gauze patches were secured with 2.5 cm wide adhesive Gothaplast tape and fixed with Gothaplast tape, 5 cm width, loosely wound round the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After an exposure time of 4 hours the tape and patches were removed, the test fields were marked and the treated skin was cleaned with mild soap and lukewarm water.
- Time after start of exposure: Patches and tape were removed 4 hours after start of exposure

SCORING SYSTEM: Skin reactions were read 1 hour after removal of patches and washing of treated skin using the scale outlined in the attached report. Reading was also made 24, 48 and 72 hours after termination of exposure. The respective scores for erythema and oedema formation for the 3 readings 24, 48 and 72 hours of each rabbit were summed up separately and divided by 6. The results are the mean scores for erythema and oedema formation of the individual rabbit. The mean scores for erythema and oedema formation in 3 rabbits used were subsequently calculated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

No skin reactions were observed among the rabbits at any of the readings.

Any other information on results incl. tables

The scores are shown in Table 1 of the attached report.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: 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 for skin irritation is required for Ukanol DOP.

Executive summary:

The primary skin irritant effect of Ukanol DOP was investigated according to the method recommended in the OECD Guideline No. 404, “Acute Dermal Irritation/Corrosion”, 1992, and EEC Guideline B.4 “Acute Toxicity (Skin Irritation)”, 29.12.1992.                      Three female albino rabbits were exposed to the test article at two skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours after termination of exposure.   No skin reactions were observed among the rabbits at any of the readings.   Under the experimental conditions described in this report, the mean score for erythema was 0.0 and for oedema 0.0.   According to the directive of the EEC commission 93/21/EEC of April 27, 1993 no classification for skin irritation is required for Ukanol DOP.