2,2'-[6-(4-methoxyphenyl)-1,3,5-triazine-2,4-diyl]bis{5-[(2-ethylhexyl)oxy]phenol}

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 05, 1997 through March 26, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

RCC Holding Company Ltd.; 4414 Füllinsdorf, Switzerland

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): CFG-C-1607
- Physical state: yellow solid
- Analytical purity: >98%
- Lot/batch No.: 002
- Expiration date of the lot/batch: 31 Aug 1998
- Stability under test conditions: stable in PEG 400 for at least 48 hours
- Storage condition of test material: in the original container at room temperature away from direct sunlight

Test animals

Species:

rat

Strain:

other: HanIbm: WIST

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, 4414 Füllinsdorf / Switzerland
- Age at study initiation: Males: 8 weeks; Females: 10 weeks
- Fasting period before study: 16 hours- Weight at study initiation: Males: 184 - 195 g; Females: 171 - 187 g
- Housing: Groups of five in Makrolon type -4 cages with standard softwood bedding.
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, Batch nos 81/96 and 84/97 rat maintenance diet available ad libitum.
- Water (e.g. ad libitum): Community tap water from Itengen, available ad libitum
- Acclimation period: One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 degrees centigrade
- Humidity (%): 40 - 70%
- Air changes (per hr):10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/kg bw
- Amount of vehicle (if gavage): 10 ml

Doses:

2000 mg/kg administered via gavage as 10 ml/kg in PEG 400

No. of animals per sex per dose:

5 males, 5 females

Control animals:

other: not applicable

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and viablity observations were four times during test day 1 and once during days 2 - 15. Body weights were recorded on test day 1 (pre-administration), 8 and 15. Each animal was examined for changes in appearance and behaviour four times during day 1, and once daily during days 2 - 15.
- Necropsy of survivors performed: yes

Statistics:

The LOGIT-Model could not be used as no deaths occurred.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs of toxicity were observed during the study period

Gross pathology:

No macroscopic organ findings were observed at necropsy.

Any other information on results incl. tables

Table 2. Body weights (g) of all test animals during the test period.

Group/Sex	Animal	Day 1	Day 8	Day 15
Group 1/ males (2000 mg/kg)	1	187.1	249.2	272.5
	2	194.8	250.5	284.9
	3	188.9	254.3	296.7
	4	183.6	248.2	280.8
	5	192.9	255.1	284.7
	Mean	189.4	251.5	283.9
	St. Dev.	4.5	3.1	8.7
	N	5	5	5
Group 2/females (2000 mg/kg)	6	186.0	211.0	219.8
	7	170.5	189.2	207.1
	8	182.0	201.2	212.5
	9	186.8	206.3	224.7
	10	179.4	199.8	217.7
	Mean	180.9	201.5	216.4
	St. Dev.	6.6	8.2	6.8
	N	5	5	5

Applicant's summary and conclusion

Conclusions:

The mean lethal dose of CGF-C-1607 after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated, because no death occurred: LD50 > 2000 mg/kg

Executive summary:

A group of five male and five female Hanlbm:WIST (SPF) rats was treated with CGF-C-1607 at 2000 mg/kg body weight by oral gavage. The test article was suspended in vehicle (PEG 400) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg body weight. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs. Mortality/ viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 before administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. No clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the range of physiological variability known for rats of this strain and age. No macroscopic organ findings were observed at necropsy.