Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: see attached file
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
test sample reference: NBW 8809/52
Form : red powder
Moisture content : < 0.2% water
CTL sample reference number : Y04203/002/00l

Test animals

Species:
rat
Strain:
other: Wistar-derived albino rats (Alpk:APfSD strain)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Animal Breeding Unit, ICI Pharmaceuticals, Alderley Park, Macclesfield, Cheshire, UK.
- Age at study initiation: young adults
- Weight at study initiation: 211-260g for males and 171-194g for females
- Housing: suspended cages (37cm length x 32cm width x 20cm height)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
Doses:
single oral dose of 2 000 mg/kg
No. of animals per sex per dose:
Five male and five female
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: once within 2 hours of dosing and again between 4 and 7 hours after dosing. Observations were then made once daily, or twice daily whenever there were signs of toxicity, up to Day 15.
- Frequency of weighing: on the day before dosing (Day -1), the day of dosing (Day 1) and on Day 3, Day 6 , Day 8 and Day 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None of the animals died.
Clinical signs:
No significant signs of toxicity were seen in any of the animals.
Body weight:
Initially all animals decreased in bodyweight (caused by fasting prior to dosing). All had gained weight by Day 3 compared to their original bodyweight (Day -1) and continued to do so until the end of the study (Day 15).

Any other information on results incl. tables

No significant signs of toxicity were seen in any of the animals. On Day 2 all the male rats were totally stained red. From Day 3 to the end of the study (Day 15) red staining was seen on the tail area only, although one animal remained totally stained up to Day 4. These observations wereattributed to the dye properties of the test sample. One female showed slight signs of urinary incontinence on Day 1.

No macroscopic abnormalities were detected at necropsy.

Applicant's summary and conclusion

Conclusions:
Five male and five female rats each received a single oral dose of 2000mg/kg of the Substance in corn oil. The animals were observed and
weighed during the following fourteen days.
There were no deaths and no significant signs of toxicity were seen in any of the animals. The estimated oral median lethal dose was in excess of
2000 mg/kg to both male and female rats
Executive summary:

LD 50: >2000mg/kg