2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(3-((2-ethylhexyl)oxy)-2-hydroxypropoxy)phenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-04-26 until 1995-07-25 (from acclimatization until report)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

24 Feb 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

31 Jul 1992

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(3-((2-ethylhexyl)oxy)-2-hydroxypropoxy)phenol

EC Number:

419-740-4

EC Name:

2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(3-((2-ethylhexyl)oxy)-2-hydroxypropoxy)phenol

Cas Number:

137658-79-8

Molecular formula:

C36 H45 N3 O4

IUPAC Name:

2-[4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5-{3-[(2-ethylhexyl)oxy]-2-hydroxypropoxy}phenol

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: Z 2651-01
- Expiration date of the lot/batch: Feb 1997
- Purity: ˃ 95%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the original container at room temperature away from direct sunlight
- Stability under test conditions: stable under storage condition
- Solubility and stability of the test substance in the solvent/vehicle: unknown in corn oil, therefore is excluded from the statement of compliance

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article, drumbled into fine powder with a mortar, was placed into a glass beaker on a tared Mettler PM480 balance, and the vehicle (corn oil) was added. A weight by volume dilution was prepared using a homogenizer (Ultra-Turrax, Janke & Kunkel, D-79219 Staufen)
- Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer (Janke & Kunkel, D-799219 Staufen)
- The preparation was made shortly before dosing

OTHER SPECIFICS:
- Description: Yellowish solid

Test animals

Species:

rat

Strain:

other: Hanlbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4 4414 Fullinsdorf / Switzerland
- Age at study initiation: males: 8 weeks, females: 10 weeks
- Weight at study initiation: males: 195.9 - 207.1 g, females: 176.7 - 192.7 g
- Housing: Groups of five in Makrolon type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, Batch no. 85/94 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period [16h] prior to application). Results of analyses for contaminants are included in the report.
- Water (e.g. ad libitum): Community tap water from Fullinsdorf, available ad libitum. Results of bacteriological, chemical and contaminant analyses are included in the report.
- Acclimation period: 7d, 26 april until 2 may 1995

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 °C
- Humidity (%): humidity between 40-67%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark (light period between 6.00 a.m. to 6.00 p.m.), music during the light period.

IN-LIFE DATES:
Treatment 03-MAY-1995
Observation 03-MAY-1995 to 17-MAY-1995
Termination 17-MAY-1995

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

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

- Rationale: Oral administration was used as this is one possible route of human exposure during manufacture, handling and use of the test article.

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: On test day 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality / Viability: Four times during test day 1 and daily during days 2-15, Clinical Signs: Each animal was examined for changes in appearance and behaviour four times during day 1, and once daily during days 2-15.

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 unscheduled deaths occurred during the study.

Clinical signs:

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

Gross pathology:

No organ abnormalities were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The mean lethal dose of the test substance after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated, because LD50 : greater than 2000 mg/kg

Executive summary:

The test article was administered to a group of 5 male and 5 female rats by oral gavage, at a single dose of 2000 mg test article/kg body weight. There were no deaths as a result of treatment with the test article. No clinical signs of toxicity were observed during the observation period. There was no effect on body weight gain during the observation period. No organ abnormalities were observed at necropsy.