Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Internal BASF-method was used, which was in large part equivalent to method described in OECD guideline 401
GLP compliance:
no
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): IBTB.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gassner
- Weight at study initiation: mean 190 g (males), 180 g (females)
- Diet (e.g. ad libitum): HERILAN-MRH Haltung, Heinrich Eggersmann KG

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: emulsions in 0.5% aqueous CMC with 2-3 drops of Cremophor EL
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 20, 13.62 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 3.8 ml
Doses:
10000, 6810 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: daily obervations
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Mortality:
No mortalities occured.
Clinical signs:
excitement, spastic gait
Body weight:
10000 mg/kg bw:
- males (mean): 190 g (d0), 211 g (d4), 231 g (d7), 269 g (d 13)
- females (mean): 180 g (d0), 195 g (d4), 208 g (d7), 223 g (d 13)
6810 mg/kg bw:
- males (mean): 190 g (d0), 216 g (d4), 238 g (d7), 265 g (d 13)
- females (mean): 180 g (d0), 174 g (d4), 206 g (d7), 215 g (d 13)
Gross pathology:
no abnormalities

Applicant's summary and conclusion

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