Phosphoric acid, mixed esters with biphenyl-4,4'-diol and phenol

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

of 2002

Deviations:

no

Remarks:

Inadvertently 14 h artificial light per 24 h, instead of 12 h per 24 h did not compromise the study results

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

of 2008

Deviations:

no

Remarks:

Inadvertently 14 h artificial light per 24 h, instead of 12 h per 24 h did not compromise the study results

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

of 1998

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese MAFF Test Data for Registration of Agricultural Chemicals, Skin Irritation (2-1-4), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

biphenyl-4,4'-diyl tetraphenyl bis(phosphate)

EC Number:

700-627-6

Cas Number:

17270-01-8

Molecular formula:

C36H28O8P2

IUPAC Name:

biphenyl-4,4'-diyl tetraphenyl bis(phosphate)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Stock supply of healthy adult rabbits
- Number and Sex: 3 females
- Age on day of dosing (Day 1): 40 - 45 weeks
- Weight prior to dosing (Day 1): Minimum 3.83 kg, maximum 4.25 kg
- Housing: Individual housing in plastic cages with peforated floor
- Environmental enrichment: Small soft white untreated wood blocks
- Diet : Standard laboratory rabbit diet (125 g/animal/day). In addition, dietary supplement of hay.
- Water: Drinking water, ad libitum
- Acclimation period: 22 to 26 weeks prior to study start under laboratory conditions.

Routine analysis of the batch of diet used for nutrients, possible contaminants and microorganisms and of the drinking water were conducted or available at the testing facility.


ENVIRONMENTAL CONDITIONS

Air conditioned animal room set at:
- Temperature (°C): 18 ± 2°C
- Relative Humidity (%): 40 to 70%
- Photoperiod: 14 hrs artificial light per 24 hrs

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Remarks:

Treatment site was moistened with 0.5 mL reverse osmosis water

Controls:

not required

Amount / concentration applied:

ca. 0.5 g of the test material per 2.5 cm x 2.5 cm clipped intact skin per animal.

Duration of treatment / exposure:

Animal # 3 (sentinel animal): Three exposures of 3 minutes, 1 hour or 4 hours in sequential order to act as a preliminary screen.
Animals # 1 & 2: 4 hours

Observation period:

72 hours post patch removal

Number of animals:

3 females

Details on study design:

TEST SITE PREPARATION:
On the day before treatment, hair was removed with clippers from the dorsolumbar region of each animal. The neat test substance was administered under a 2-ply 25 mm x 25 mm porous gauze pad secured with 'blenderm' surgical tape to intact skin sites moistened with 0.5 mL reverse osmosis water. For exposures of one hour or more each treatment site was covered additionally with cotton wool and "Tubigrip" elasticated bandage dressing for the duration of the exposure period.

On each animal an additional site was similarly treated with the exception of test substance and acted as a control.

TREATMENT PERIOD AND REMOVAL OF TEST SUBSTANCE
At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with lukewarm water (30-40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.

SKIN EVALUATION:
The treated skin patches were evaluated immediately after patch removal (for 3 minute and 1 hour exposures) and at 1, 24, 48 and 72 h afterwards, whereby only the data for the 4 hour exposures were reported. The scoring system for the grading of skin reactions is listed in Table 1 (next field below).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

In each animal, erythema, eschar or edema formation or any other skin reactions were not evident at any observation time point of the study, i.e. not evident at 1, 24, 48 or 72 hours after the end of administration.

Other effects:

Signs of systemic toxicity or ill health were not evident.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating