tetrakis(2,6-dimethylphenyl)-m-phenylene biphosphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 27 September and 30 september 1995.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

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 (incl. QA statement)

Remarks:

Date of inspection: 31/01/1994 Date of signature: 16/03/1994

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

432-770-2

EC Name:

-

Cas Number:

139189-30-3

Molecular formula:

C38 H40 O8 P2

IUPAC Name:

3-{[bis(2,6-dimethylphenoxy)phosphoryl]oxy}phenyl bis(2,6-dimethylphenyl) phosphate

Constituent 2

Reference substance name:

Tetrakis (2,6-dimethylphenyl)-m-phenylene biphosphate

IUPAC Name:

Tetrakis (2,6-dimethylphenyl)-m-phenylene biphosphate

Details on test material:

- Name of test material (as cited in study report): PX-200- Molecular formula (if other than submission substance): same as submission substance- Molecular weight (if other than submission substance): same as submission substance- Smiles notation (if other than submission substance): same as submission substance- InChl (if other than submission substance): same as submission substance- Structural formula attached as image file (if other than submission substance): same as submission substance- Substance type: white powder- Physical state: solid- Analytical purity: not stated- Impurities (identity and concentrations): not stated- Composition of test material, percentage of components: not stated- Isomers composition: not stated- Purity test date: not stated- Lot/batch No.: P-3- Expiration date of the lot/batch: not stated- Radiochemical purity (if radiolabelling): not stated- Specific activity (if radiolabelling): not stated- Locations of the label (if radiolabelling): not stated- Expiration date of radiochemical substance (if radiolabelling): not stated- Stability under test conditions: not stated- Storage condition of test material: room temperature- Other: not stated

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: David Percival Ltd., Moston, Sandbach, Chesire, UK- Age at study initiation: 12 to 16 weeks old- Weight at study initiation: 2.41 to 2.67 kg- Housing: The animals were housed individually in suspended metal cages.- Diet: Free acess allowed throughout the study to STANRAB SQC Rabbit Diet.- Water: Free acess allowed throughout the study to mains drinking water.- Acclimation period: minimum of 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 17 to 21°C- Humidity (%): 56 to 65%- Air changes (per hr): approximately 15 changes per hour- Photoperiod (hrs dark / hrs light): 12 hours light followed by 12 hours darknessIN-LIFE DATES: From: Day 0 To: End of study

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped free of fur

Vehicle:

other: moistened with distilled water

Controls:

no

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 g was moistened with 0.5 ml of distilled water- Concentration (if solution): not applicableVEHICLEnot applicable

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE- Area of exposure: 2.5 cm x 2.5 cm- % coverage: not stated- Type of wrap if used: surgical adhesive tape (BLENDERM: approximate sixe 2.5 cm x 4 cm)REMOVAL OF TEST SUBSTANCE- Washing (if done): removed by gentle swabbing with cotton wool soaked in distilled water.- Time after start of exposure: 4 hoursSCORING SYSTEM:The score for erythema and oedema at the 24 and 72 hour readings were totalled for the 3 test rabbits (12 values) and this total was divided by 6 to give the primary irritation index of the test material.The EU classification system was used

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: calculated at 24, 48 and 72 hours.

Score:

0

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Remarks:

108 Female

Basis:

mean

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Remarks:

114 Female

Basis:

mean

Time point:

other: mean score for 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 4

Irritation parameter:

erythema score

Remarks:

91 Female

Basis:

mean

Time point:

other: mean score for 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Remarks:

108 Female

Basis:

mean

Time point:

other: mean score for 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Remarks:

114 Female

Basis:

mean

Time point:

other: mean score for 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 7

Irritation parameter:

edema score

Remarks:

91 Female

Basis:

mean

Time point:

other: mean score for 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Any other information on results incl. tables

The individual score for erythema/eschar and oedema are given in Table 1. Mean values required for EU labelling regulations are given in Table 2. (Please see Attachment 1).

Very slight erythema was noted at 2 treated skin sites one hour after patch removal.

All treated skin sites appeared normal at the 24 hour observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material, PX-200, produced a primary irritation index of 0.0 and was classified as a non irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute dermal irritation/corrosion" (adopted 17 July 1992) and Method B4 of Commission directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.