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: Study carried out according to OECD Guideline 423, by an accredited laboratory (AFSSAPS, GIPC & COFRAC)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Remarks:
testing laboratory accredited by AFSSAPS, GIPC & COFRAC
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
batch 29

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
study carried out following ethic rules stated in Council Directive 86/609/EEC

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Single administration using a suited volume syringe provided with an appropriate cannula
Doses:
1.5 ml / kg of body weight (= 2000 mg/kg of body weight)
Note: density = 1.339
No. of animals per sex per dose:
2000 mg/kg of body weight : 6 females
Control animals:
no
Details on study design:
According to OECD Guideline 423, study began with 3 animals. Then, as no mortality was observed during the 14 following days, 3 others animals were used (same dose, same conditions) : here again, no mortality observed during the 14 following days --> end of the study
Statistics:
_

Results and discussion

Preliminary study:
According to OECD Guideline 423, study began with 3 animals. Then, as no mortality was observed during the 14 following days, 3 others animals were used (same dose, same conditions) : here again, no mortality observed during the 14 following days --> end of the study
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
0% mortality at the dose of 2000 mg /kg of body weight
Clinical signs:
Pilo-erection from the administration to Day 2
Motor activity reduced on Day 2 (only for 2 animals)
Day 3 to Day 15: nothing to report
Body weight:
See Table below
Gross pathology:
_
Other findings:
_

Any other information on results incl. tables

Body weight:

Animal Nr Weight (g)
Day 1 Day 4 Day 8 Day 15 Day 15 -Day 1
Step 1 0316 216.1 238.7 265.6 286.6 70.5
0317 230.5 253.7 266.4 278.1 47.6
0318 218.9 233.5 236.4 257.0 38.1
Step 2 0319 215.0 229.2 248.9 253.3 38.3
0320 230.9 251.1 263.8 279.3 48.4
0321 222.1 236.7 240.8 270.0 47.9
Average 222.3 240.5 253.7 270.7 48.5
Standard deviation 7.0 9.8 13.4 13.2 11.8

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information LD50 > 2000 mg/kg Criteria used for interpretation of results: EU
Conclusions:
This substance is not classified regarding oral acute toxicity, according to the criteria of Directive 67/548/ EEC