5-butoxy-2-[4-(4-butoxy-2-hydroxyphenyl)-6-(2,4-dibutoxyphenyl)-1,3,5-triazin-2-yl]phenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Wistar

Remarks:

HanIbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd
- Age at study initiation: females: 10 weeks, males: 8 weeks
- Weight at study initiation: females: 169.8 - 181.5g, males: 199.6 - 208.3g
- Fasting period before study: approximately 16.5 hours
- Housing: Groups of three
- Diet (e.g. ad libitum): Pelleted standard Kliba 3433, batch no. 40/99, rat maintenance diet (Provimi Kliba AG, Kaiseraugst) available ad libitum (except for the ovemight fasting period prior to intubation).
- Water (e.g. ad libitum): Community tap water from Itingen, available ad libitum.
- Acclimation period: 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
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hour/12 hour

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 300

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml / kg body weight

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each animal was examined for changes in appearance and behavior four times during day 1, and once daily during days 2-15. A description of all abnormalities was recorded. Bodies were weighted on test day 1 (pre-administration), 8 and 15. Mortality was monitored four times during test day 1 and once daily during days 2-15.
- Necropsy of survivors performed: yes, at the end of the observation period all animals were sacrificed by intraperitoneal injection of NARCOREN (Rhone Merieux GmbH) at a dose of at least 2.0 ml/kg body weight (equivalent to at least 320 mg sodium pentobarbitone/kg body weight). The animals were examined macroscopically and all abnormalities recorded.

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 signs of toxicity

Mortality:

No death occurred during the study.

Clinical signs:

other: No clinical signs were noted during the observation period.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No signs of toxicity were observed up to a dose of 2000 mg/kg bw.