2,2`-[6-(phenylamino)-heteromonocycle-2,4-diyl]diphenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 17th December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Directive 2004/73/EC, B.1tris "Acute Oral Toxicity-Acute Toxic Class Method"

Version / remarks:

April 29, 2004

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2`-[6-(phenylamino)-1,3,5-triazine-2,4-diyl]diphenol

Cas Number:

1248-66-4

Molecular formula:

C21H16N4O2

IUPAC Name:

2,2`-[6-(phenylamino)-1,3,5-triazine-2,4-diyl]diphenol

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services CH-4414 Füllinsdorf/Switzerland
- Age at study initiation: 11 weeks
- Housing: groups of 3 in Makrolon type-4 cages with wire mashes tops and standard softwood bedding.
- Diet: ad libitum. Pelelted standard. Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 89/06)
- Water: ad libitum. Community tap water from Füllinsdorf

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70% (values above 70% during cleaning process possible)
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod: automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

The animals received a single dose of the test item by oral gavage administration at 2000 mg/kg bw after being fasted for approximately 18 to 19 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing.
The dosing volume was 10 mL/kg bw.
Oral administration was considered to be an appropriate application method as it is a possible route of human exposure during manufacture, handling and use of the test item.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

OBSERVATION
Mortality/Viability: daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
Body weights: On test days 1 (prior to administration), 8 and 15.
Clinical signs: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15.

PATHOLOGY
Necropsies were performed. All animals were killed at the end of the observation period by Carbon dioxide asphyxiation.

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All animals survived until the end of the study period.

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

The body weight of the animals was within the range commonly recorded for this strain and age.

Gross pathology:

No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: not classified as harmful/toxic according to the CLP Regulation (EC) No.1272/2008

Conclusions:

LD50 (female rat) > 2000 mg/kg bw

Executive summary:

The test item was evaluated for acute oral toxicity in Wistar rats as per OECD Guideline No. 423 and Directive 2004/73/EC, B.1tris "Acute Oral Toxicity-Acute Toxic Class Method", April 29,2004.

Two groups, each of three female HanRcc:Wist (SPF) rats, were treated with test item by oral gavage administration at a dosage of 2000 mg/kg bw. The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg.
The animals were examined daily during the acclimatization period and mortality, viability, and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. 
All animals survived until the end of the study period. No clinical signs were observed. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. 

The median lethal dose of test item after single oral administration to female rats observed over a period of 14 days is greater than 2000 mg/kg bw.