Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted according to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1987)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide

EC Number:

423-340-5

EC Name:

Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide

Cas Number:

162881-26-7

Molecular formula:

C26 H27 O3 P

IUPAC Name:

[phenyl(2,4,6-trimethylbenzoyl)phosphoryl](2,4,6-trimethylphenyl)methanone

Details on test material:

- Name of test material (as cited in study report): TKA 40135 (CGI 819)
- Physical state: Pale yellow powder
- Lot/batch No.: 1031/2A
- Purity: 98.4 % (analytical certificate No. 960604/01)
- Expiration date of the lot/batch: November 1997
- Storage of test material: at 4°C in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan U.K. Ltd., Bicester, Oxon, England
- Age at study initiation: approximately four to seven weeks
- Weight at study initiation: approximately 103 to 121 g
- Fasting period before study: access to food only was prevented overnight prior to and approximately 4 hours after dosing.
- Housing: in groups of up to five rats of the same sex in metal cages
- Diet (e.g. ad libitum): standard laboratory rodent diet (SDS LAD 1), ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12hrs/12 hrs

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test substance was formulated at a concentration of 20% w/v in distilled water and administered at a volume of 10 mL/kg bw.
The test substance was prepared on the day of dosing. As the test material was advised by the sponsor to be light sensitive, the test formulation was prepared under safelight and the formulation container kept wrapped with tin foil.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Five animals per sex and group were used.

Control animals:

no

Details on study design:

MORTALITY AND CLINICAL SIGNS OF TOXICITY
The animals were checked at least twice daily for any mortalities. They were observed for clinical signs soon after dosing and at frequent
intervals for the remainder of day 1; on subsequent days animals were observed twice a day until ending of the observation period. The animals were observed for 14 days after dosing.

BODYWEIGHT
The bodyweight of each rat was recorded on days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes and group mean bodyweights were calculated.

PATHOLOGY
The animals were sacrificed for the purpose of necropsy on day 15 by cervical dislocation. They were subjected to gross pathological examination.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortalities were observed at the tested dose level of 2000 mg/kg bw.

Mortality:

All animals survived the single oral dosage with 2000 mg/kg bw of the test material.

Clinical signs:

other: Piloerection was observed in all rats within two minutes of dosing, persisting in all animals throughout day 2 of observation. There were no other clinical signs of toxicity. No more signs were seen from day 3 until the end of the observation period.

Gross pathology:

Necropsy was inconspicuous in all animals sacrificed on day 15.

Any other information on results incl. tables

Bodyweight changes:

Sex	Dose	Animal Number	Body weight (g) at
			Day 1	Day 8	Day 15
Males	2000 mg/kg bw	1	121	203	258
		2	108	171	208
		3	119	183	228
		4	118	193	252
		5	117	189	236
		mean	117	188	236
Females	2000 mg/kg bw	6	104	142	162
		7	118	170	200
		8	104	148	176
		9	103	146	168
		10	118	172	195
		mean	109	156	180

 

Body weight gains during the observation period:

Sex	Dose	Animal Number	Body weight gain (g) for
			Week 1	Week 2
Males	2000 mg/kg bw	1	82	55
		2	63	37
		3	64	45
		4	74	59
		5	71	47
Females	2000 mg/kg bw	6	38	20
		7	52	30
		8	44	28
		9	43	22
		10	54	23