4,6-diphenyl-1,3,5-triazin-2(1H)-one

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: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(adopted 1987)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

FAT 92376/A

IUPAC Name:

FAT 92376/A

Details on test material:

- Name of test material (as cited in study report): FAT 92376/A
- Physical state: solid, white crystals
- Analytical purity: 98%
- Lot/batch No.: 10.26
- Storage condition of test material: room temperature
- Other:
Date of reanalysis: Dec 1996
Test material received: 11 Feb 1993

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Age at study initiation: "young", no further data available
- Weight at study initiation: 174 - 211 g
- Fasting period before study: Before administration of dose animals were fasted overnight
- Housing: 5 per cage in Makrolon Type 4 cages
- Diet: NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55+/-10
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5 % (w/v) hydroxypropyl-methylcellulose in 0.1 % (w/v) aqueous polysorbate 80

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: twice daily (am and pm) at week days; once (am) at weekends
Weighing: immediately before administration and on day 7 and 14
Signs and symptoms: daily
- Necropsy of survivors performed: yes
The animals were submitted to a gross necropsy at the end of the observation period.

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 mortality was observed.

Mortality:

No mortalities occured in this study.

Clinical signs:

2000 mg/kg bw, males: piloerection was observed directly after administration until 5 days after administration (moderate at 3 and 5 h, slight at other time points). Hunched posture was observed in all animals until day 2 and dyspnea was observed until 1 day after administration.

2000 mg/kg bw, females: piloerection was observed directly after administration until 3 days after administration (moderate at 3 and 5 h, slight at other time points). Hunched posture was observed in all animals until day 2 and dyspnea was observed until 1 day after administration.

Body weight:

see table 1 ("Any other information on results incl. tables")

Gross pathology:

At necropsy, no deviations from normal morphology were found in all animals.

Any other information on results incl. tables

Table 1: Individual body weights of male and female rats at day 0, 7, and 14:

Animal number	Body weights (g)
	Day 0	Day 7	Day 14
Males
1	201	271	303
2	211	269	320
3	202	271	296
4	210	260	286
5	209	265	301
Mean	207	267	301
SD	4.7	7.9	12.4
Females
1	174	206	218
2	176	210	223
3	198	216	218
4	191	227	251
5	192	209	238
Mean	186	214	230
SD	10.6	8.3	14.5