Registration Dossier

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:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Basazol Gelb 8511
- Physical state: powder
- Analytical purity: 96%
- Lot/batch No.: 6123,V. 6781

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: R. K. THOMAE GMBH, D-7950 BIBERACH, FRG
- Weight at study initiation: male: 186g; female: 176g
- Fasting period before study: the animals were given no feed about 16 hours before administration, but water was available ad libitum.
- Housing: stainless steel wird mesh cages
- Diet: KLIBA-Labordieat 343
- Water: tap water ad libitum
- Acclimation period: for at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Doses:
464, 1000, 2000 and 2200 mg/kg
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: several times on the day of administration; at least once each workday
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 200 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 200 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 2 000 mg/kg bw
Mortality:
all doses: no male animal died
2000 mg/kg: 3 females died on day 1
2200 mg/kg: 2 females died after day 1 and 1 female on the second day
Clinical signs:
dyspnoea, apathy, staggering, piloerection, spastic gait, sheared fur, diarrhea, discoloured redbrown feces, discoloured orange urine
Gross pathology:
Animals that died: 2.000 mg/kg + 2.200 mg/kg, 3 females: General congestion.
2.000 mg/kg, 3 females: Gastrointestinal tract: filled with test substance; 2.200 mg/kg, 1 female: Stomach/small intestines: mucosa discoloured due to test substance. Contents discoloured. 2.200 mg/kg, 2 females: Glandular stomach: discoloured due to test substance. Intestines: contents discoloured, liquid; further diagnosis not possible (autolysis)
Sacrificed animals:
464 + 1.000mg/kg (5 males and 5 females), 2.000 + 2.200mg/kg (5 males and 2 females):
No pathologic findings noted.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU