Biphenyl-4,4'-diyl tetrakis(2,6-dimethylphenyl) bis(phosphate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7-10 December 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Data have been generated according to current internationally recognised study guidelines and in accordance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Biphenyl-4,4'-diyl tetrakis(2,6-dimethylphenyl) bis(phosphate)

EC Number:

807-250-7

Cas Number:

147263-99-8

Molecular formula:

C44H44O8P2

IUPAC Name:

Biphenyl-4,4'-diyl tetrakis(2,6-dimethylphenyl) bis(phosphate)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species and strain: New Zealand White rabbits
Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, HUNGARY Justification of strain: The New Zealand White albino rabbit is one of the standard strains used for acute irritation toxicity studies.
Animal health: Only animals in acceptable health condition were used for the test.
Number of animals: 3
Age of animals at treatment: ~11 weeks old
Sex: Male Body weight range at the beginning of the life phase: 2770-2799 g at the end of the life phase: 2934-2961 g
Date of receipt: 01 December 2010
Acclimation time: 6 days
Animal identification: The animals were identified by engraved ear tags. The cages were marked with individual identity cards with information about study code, sex, cage number, dose group and individual animal number.

Lighting periods: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20±3°C
Relative humidity: 30-70 %
Housing/Enrichment: Rabbits were individually housed in AAALC approved metal wire rabbit cages (65x65 cm with height of 45 cm). Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
Ventilation: 15-20 air exchanges/hour

Animals received PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi út, Hungary, ad libitum.
The animals received municipal tap water, as for human consumption, ad libitum, from an automatic system.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

A single dose of 0.5 g was applied to the test area. Sufficient water to damp the material were used to ensure good contact with the skin

Duration of treatment / exposure:

4 hrs

Observation period:

24, 48 and 72 hours after patch removal

Number of animals:

3, male

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 4

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

other: 72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Any other information on results incl. tables

At observation 1 hour after patch removal, very slight oedema (score 1) was observed in one animal.

At observation 24 hours after patch removal, very slight erythema (score 1) was observed in one animal.

At observation 48 and 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals.

As no clinical signs were observed up to 72 hours after patch removal, the study was terminated after the 72 hour observation.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.33, 0.00 and 0.00 respectively.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.00, 0.00 and 0.00 respectively

The Primary Irritation Index (considering readings at 24, 48 and 72 hours after patch removal) was calculated as 0.11.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance caused minor skin responses up to 24 hours after exposure. The substance is not irritating to skin.

Executive summary:

The acute skin irritation of the substance was measured following exposure to the intact skin of shaved New Zealand white rabbits as prescribed in the OECD 404 test method in accordance with GLP. The substance caused minor skin responses up to 24 hours after exposure. The substance is not irritating to skin.