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

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8-23 February 2011

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

other: RjHan:WI rats

Sex:

female

Details on test animals or test system and environmental conditions:

Species and strain: RjHan:WI rats
Source: Laboratoire Elevage Janvier, B.P. 4105, Route des Chênes Secs, 53940 Le Genest-St-Isle CEDEX FRANCE
Hygienic level at supplier: SPF
Hygienic level during the study: Standard housing conditions
Number of animals: 6 animals, 3 animals/group
Sex: Female, nulliparous and non-pregnant.
Age of animals at dosing: Young healthy adult rats, 9 weeks old
Date of receipt: 03 February 2011
Body weight at treatment: 195 – 212 g
Acclimation period: At least 5 days

Housing: 3 animals / cage
Cage type: Type III polypropylene/polycarbonate
Bedding: Lignocel Bedding for Laboratory Animals was available to animals during the study. A copy of the Certificate of Analysis is retained in the archive at LAB Research Ltd.
Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: 15-20 air exchanges/hour
Enrichment: Animals were housed by group to allow social interaction and with deep wood sawdust bedding to allow digging and other normal rodent activities.

Animals received ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany ad libitum, and tap water from the municipal supply, as for human consumption from 500 ml bottle ad libitum.

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

A single oral gavage administration was followed by a fourteen-day observation period. On the day before treatment, the animals were fasted. The food but not water was withheld during an overnight period. Animals were weighed just before treatment. The test item was administered by oral gavage in the morning. The food was returned 3 hours after the treatment.

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

None

Body weight:

No effects

Gross pathology:

Dark/red discoloration of the lungs in 1/6 animals was regarded as incidental. There was no evidence of the test item-related macroscopic observations at a dose level of 2000 mg/kg bw.
A single oral gavage of PX-202 to the RjHan:WI rat at a dose level of 2000 mg/kg bw followed by a 14 day of observation period, was not associated with any test item-related gross findings.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is non toxic with a LD50 >2000mg/kg bw.

Executive summary:

The acute oral toxicity of the substance was measured using the acute toxic class method prescribed in the OECD 423 test method in accordance with GLP. No toxicity was observed in the study. The substance is non toxic with a LD50 >2000mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

K1

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of acute toxicity – oral endpoint
An absence of toxicity was observed following exposure at 2000mg/kg bw.

Justification for classification or non-classification

The acute oral toxicity of the substance was measured using the acute toxic class method prescribed in the OECD 423 test method in accordance with GLP. No toxicity was observed in the study. The substance is non toxic with a LD50 >2000mg/kg bw.