Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted on 24th February 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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