2-Aminoethanol reaction products with cyclohexane and peroxidized N-butyl-2,2,6,6-tetramethyl-4-piperidinamine-2,4,6-trichloro-1,3,5-triazine reaction products

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-02-03 - 1998-04-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted on 24th February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

426-650-9

EC Name:

-

Cas Number:

191743-75-6

Molecular formula:

Unspecified

IUPAC Name:

2-Aminoethanol reaction products with cyclohexane and peroxidized N-butyl-2,2,6,6-tetramethyl-4-piperidinamine-2,4,6-trichloro-1,3,5-triazine reaction products

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Boyertown, PA (on 12/02/97 and 1/20/98)
- Age at study initiation: Animals were born the weeks of 9/30 through 12/11/97, Experimental Start Date: 02/05/98
- Weight at study initiation: 286-300 g (males), 236 - 288 g (females)
- Housing: 5 animals/sex/cage in suspended wire cage, bedding was changed three times/week
- Diet: Fresh Purina Rat Chow, ad libitum, except for 16-20 hours prior to dosing
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: temperature-controlled animal room
- Photoperiod: 12 hours dark / 12 hours light
- Animal room was kept clean and vermin free

IN-LIFE DATES: From: 1998-02-05 To: 1998-02-19

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE:
- Concentration in vehicle: see dosage preparation
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: to make dosing by gavage possible
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED:
A single dose was administered orally by syringe and dosing needle at a dose level of 5000 mg/kg bw. All animals received the same concentration of dosing solution.

DOSAGE PREPARATION:
15 g of test item was mixed with corn oil to a total volume of 30 mL

Doses:

5000 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: 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects
- Animals were observed twice daily for mortality
- Body weights were recorded immediately pretest, on days 3 and 7, at death or at termination in the survivors
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Nine of ten animals survived the 5000 mg/kg bw oral dose.

Clinical signs:

Red staining of the nose/mouth area was noted in the animal which died on day 1. Physical signs noted in the survivors included emaciation, chromorhinorrhea, diarrhea and red staining of the nose/mouth area.

Body weight:

Body weight changes of male survivors were normal. Weight loss, associated with an obstructed water sipper, was noted in females but all returned to normal by day 14.

Gross pathology:

Necropsy results of the animal which died on day 1 revealed that the death was due to a dosing error which resulted in the test item being deposited into the lungs rather than to a toxic effect of the test item. Necropsy results of the survivors were normal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met