Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 June - 03 July 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Electrode binder [CAS No. 65996-93-2]
- Name of test material (as cited in study report): 101.110
- Substance type: organic
- Physical state: solid, black powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld/Germany
- Age at study initiation: no data
- Weight at study initiation: 180.0 - 200.0 g (m); 151.9 - 181.9 g (f)
- Fasting period before study: 16 h
- Housing: max. 5/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 7 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-2 °C
- Humidity (%): 50 - 85
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50 % (w/v)
- Amount of vehicle (if gavage): The TS was applied in a constant volume of 5-% carboxymethylcellulose. 
- Justification for choice of vehicle: inert carrier material for suspending insoluble solids


MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw



CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
The  dose was derived from a range-finding test and corresponded to the  maximally applicable volume.

Doses:
15000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 0 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic organpathology
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Mortality:
none
Clinical signs:
none
Body weight:
normal
Gross pathology:
no particular findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU