Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 1994
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): RA 3643 BXA
- Substance type: white powder
- Physical state: solid
- Expiration date of the lot/batch: January 4, 1995
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
5 males + 5 females/group
- Source: Charles River Italia SpA Calco (COMO) Italy
- Age at study initiation: 7-9 weeks
- Weight at study initiation: Males: 225-250g Famales: 200-225g
- Diet (e.g. ad libitum): GLP 4 RF 21 top certificate pelletted diet; the content were crude protein (18.5%), crude fat (3%), crude fiber (6%), crude ash (7%). The diet was supplemented with vitamins and trace elements. The diet was available ad libitum.
- Water (e.g. ad libitum): from the municipal water main system. Ad libitum.
- Acclimation period: five days before the start of the test

ENVIRONMENTAL CONDITIONS
5 animals/sex/cage in T11C air conditioned room
- Temperature (°C): 22°C +/- 2
- Humidity (%): 55+/- 10
- Air changes (per hr): about 20/hour filtered on HEPA 99.97%
- Photoperiod (hrs dark / hrs light): 12 hour cycle (7am-7pm)
-Cage size: grill cages 40.5x38.5x18h cm with stainless steel feeder.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% methylcellulose water solution
Doses:
2000 mg/Kg
No. of animals per sex per dose:
5 male and 5 female 2000 mg/kg
Control animals:
yes
Details on study design:
- Observation period: 14 days after the administration
- Observation of clinical signs and mortality: at 30 minutes, 2, 4 and 6 hours on the first day after the administration and the twice a day up to termination of the observation period

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No animals died during the observation period.
Clinical signs:
No clinical signs during the 14 day observation period.
Body weight:
Body weight gain was considered within normal limits for animals of this strain and age.
Gross pathology:
On all surviving animals killed by excision of the femoral arteries, after i.p. overdosage anesthesia with 5% sodium pentobarbital, at the end of the observation period. No appreciable macroscopic findings were evident in any treated rat.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test article, when administered to rats as a single dose by oral route, was higher than 2000 mg/kg. The substance is to be considered not toxic.