CGL 210

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

- weight of animals not mentioned

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

439-020-3

EC Name:

-

Cas Number:

446824-06-2

Molecular formula:

C43H55N3O10 - C65H95N3O14

IUPAC Name:

1-isoctyloxycarbonyl ethylated 2,4,6 tris (2,4- hydroxyphenyl) -1,3,5 triazine derivatives

Details on test material:

- Substance type: Organic
- Physical state: Viscous liquid
- Storage condition of test material: Room temperature (approx. 20°C), away from direct sunlight

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 CH-4414 Fullinsdorf / Switzerland
- Age at study initiation: 8-10 weeks
- Weight at study initiation: not mentioned
- fastened for 16-20h, access to water
- Housing: In groups of three per sex in Makrolon type-4 cages with wire mesh tops and standardized softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
- Diet (e.g. ad libitum): maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst/ Switzerland) ad libitum. The females received from the 24-OCT-2001 until the 30-OCT-2001 batch no. 73/01, then to the end of the study batch no. 74/01. The male rats received batch no. 74/01. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum): Community tap-water, from Itingen ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- 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 (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES:
Delivery of Animals 24-OCT-2001 (females), 26-OCT-2001 (males)
Acclimatization 24-OCT to 30-OCT-2001 (females), 26-OCTto 1-NOV-2001 (males)
Treatment (first dose) 31-OCT-2001 (females, 2000 mg/kg), 2-NOV-2001 (males, 2000 mg/kg)
Observation 31-OCTto14-NOV-2001 (females), 2-NOVto16-NOV-2001 (males)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial performed before experimental starting date.
- Lot/batch no. (if required): 424718/113701

DOSAGE PREPARATION (if unusual):
The preparations were made shortly before each dosing.
The test item was weighed into a tared glass beaker on a suitable precision balance and the
vehicle added (weight:volume). The mixtures were prepared using a ultra sound bath then a
magnetic stirrer.
Homogeneity of the test item in the vehicle was maintained during administration using a
magnetic stirrer.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 males
3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation for mortality/viability daily during acclimatization, then twice daily during days 1-15, for clinical signs daily during acclimatization and then 5 times on day 1, daily during days 2-15, body weighing days 1, 8,15
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

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:

Slightly ruffled fur was evident in two females at 2000 mg/kg on the fist test day.

Body weight:

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

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose of the test item after single oral administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat) >2000 mg/kg bodyweight

Executive summary:

One group of three male or three female HanBrl: WIST (SPF) rats was treated by oral gavage with the test substance at 2000 mg/kg body weight. The test item was suspended in vehicle (PEG 300) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. The animals were examined for clinical signs daily during the acclimatization period, four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded daily during the acclimatization period and together with clinical signs at the same time intervals on test day 1 and twice daily on test days 2-15. Body weights were recorded on 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. Slightly ruffled fur was evident in two females at 2000 mg/kg on the fist test day. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.