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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Only 7 days observation period, higher doses than limit dose tested
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid

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 176 g (male), 167 g (female)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% CMC in water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30%
- Amount of vehicle (if gavage): 21.4, 10.66 ml/kg


MAXIMUM DOSE VOLUME APPLIED: 21.4 ml/kg
Doses:
3200, 6400 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 400 mg/kg bw
Mortality:
no mortalities
Clinical signs:
no clinical signs observed
Body weight:
Slight decrease in weight towards the end of observation period
Gross pathology:
no abnormalities observed

Any other information on results incl. tables

Body weights (in g):

6400 mg/kg bw 1 h 72 h 7 d
male     187 222 210
176 208 200
167 200 200
182 216 212
166 204 197
176 210 204
female          164 174 164
161 172 161
173 180 170
157 164 154
168 182 168
165 174 163
3200 mg/kg bw 1 h 72 h 7 d
male   180 206 196
176 206 200
176 200 194
174 202 196
178 219 210
177 207 199
female        170 179 168
168 185 176
158 174 168
174 188 180
179 192 188
170 184 176

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met