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 according to OECD guideline under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
5 male and 5 female rats in one step with two doses
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- SPF-Wistar rats, strain Winkelmann, Paderborn
- Mean body weight male: 210 - 230 g
- Mean body weight female: 190 - 210 g
- Fasting period before study: 16 hours
- Housing: animals were kept in groups of 5 male and 5 female "at random" divided in single cages
- Diet: laboratory standard diet (Altromin, Lage), ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22.5 ± 2.5 °C
- Humidity: 40 - 60 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
Administration by oral gavage, using a non-flexible stomach tube, as 10% suspension in 1% CMC.

VEHICLE
- Concentration in vehicle: 10 %


MAXIMUM DOSE VOLUME APPLIED:
- Dosage level 2000 mg/kg bw: 2.0 ml/100 g bw
- Dosage level 5000 mg/kg bw: 5.0 ml/100 g bw
Doses:
2000 and 5000 mg/kg bodyweight
No. of animals per sex per dose:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
Not applicable. No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
During the study, no mortality could be observed.
Clinical signs:
No clinical signs of toxicity were observed during the study.
Body weight:
The body weight of the surviving animals was within the range commonly recorded for animals of this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value of the test item in Wistar rats was established to exceed 5000 mg/kg body weight. Based on these results and according to the EC criteria for classification and labelling according to DSD (Directive 67/548/EEC) or GHS/CLP (Regulation (EC) No. 1272/2008), the test item does not have to be classified and has no obligatory labelling requirement for oral toxicity.
Executive summary:

The test item did not show any mortality in rats up to 5000 mg/kg bodyweight and is therefore considered practically non-toxic.