Phenol, 2-[4,6-bis([1,1'-biphenyl]-4-yl)-1,3,5-triazin-2-yl]-5-[(2-ethylhexyl)oxy]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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:

other: HanBrl: Wist (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: RCC Ltd, Biotechnology and Animal Breeding Division, Fuellinsdorf / Switzerland- Age at study initiation: males = 8 weeks, females = 10 weeks- Weight at study initiation: males = 187.7 - 210.4 g, females = 181.5 - 184.9 g- Fasting period before study: 16 to 20 hours- Housing: three per sex in Makrolon type-4 cages with wire mesh tops and standardized softwood bedding- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 77/01 (Provimi Kliba AG, Kaiseraugst/ Switzerland) ad libitum.- Water (e.g. ad libitum): Community tap-water, from Itingen ad libitum- Acclimation period: one weekENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 3- Humidity (%): 30-70- Air changes (per hr): 10-15- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light/12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Remarks:

PEG 300

Details on oral exposure:

VEHICLE- Lot/batch no. (if required): 430424/1 54701 (animal nos. 1-3), 430424/1 25001 (animal nos. 4-6)MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

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: Clinical signs were noticed daily during acclimatization and at least four times on test day 1 after the test item administration. Once daily during days 2-15. All abnormalities were recorded. Weighing was done on test days 1 (pre-administration), 8 and 15.- Necropsy of survivors performed: yes

Statistics:

Not necessary

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred during the study.

Clinical signs:

other: No clinical signs were noted during the course of the study.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met