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: Limit test, predating OECD protocols and GLP. Yet study outcome sufficient for decision on classification

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: IRLG (1981)
Deviations:
no
Principles of method if other than guideline:
range-finding study in the rat. 250, 500, 2500 and 5000 mg/kg bw on 2 males and 2 females per group, oral, gavage.
in the absence of any mortality, 5000 mg/kg bw on 5 male, 5 female animals
GLP compliance:
no
Test type:
other: Limit test "avant la lettre"
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: suspension
Remarks:
migrated information: dispersion

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton laboratories
- Age at study initiation: not given
- Weight at study initiation: 190-210 gr (males; 185-195 gr (females)
- Fasting period before study: overnight
- Housing: caged singly in Makrolon cages
- Diet (e.g. ad libitum): at lib
- Water (e.g. ad libitum): at lib
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 40-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: September To: October (dates not specified)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
range-finding: 250, 500, 2500 and 5000mg/kg bw . Limit test: 5000 mg/kg bw
No. of animals per sex per dose:
range finding: 2/2, final study 5/5
Control animals:
no
Statistics:
not applicable

Results and discussion

Preliminary study:
range-finding study in the rat. 250, 500, 2500 and 5000 mg/kg bw on 2 males and 2 females per group, oral, gavage.
No mortality, no clinical effects
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD0
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD0
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
lethargy from 30 minutes to one and and a half hour after dosing in 2 males and 2 females
Body weight:
Mormal increase during recovery period (see table)
Gross pathology:
none
Other findings:
none

Any other information on results incl. tables

body weights during recovery

Dose

(mg/kg)

animal nr Nr. , gender

Tag-1

Tag1

Tag8

Tag 1 5

5000

1, m

225

200

280

350

 

2, m

210

190

260

300

 

3,m

225

210

290

345

/

 

4,m

220

' 205

275

325

 

5, m

210

190

275

310 -

 

6 ,f

200

1 85

215

225

7,f

210

190

225

240

 

8,f

205

'1 95

280

330

 

9,f

190

1 85

230

260

-

10, f

205

1 95

2 30

230

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
non toxic
Executive summary:

Based on the results of the range-finding study, 10 sprague=dawley rats (5m, 5f) were given 5000 mg/kg bw, suspended in water by gavag of sodium mehtally sulphonate.

in 4/10 animals, a brief period of lethargy shorty after dosing was observed

Since all animals survived the 14 -day recovery period, the LD0 can be set at =5000 mg/kg bw.

No gross pathology was observed at obduction