Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013-01-28 to 2013-02-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
(1998)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Purity: >99%
Density of the test item was 1.13 g/mL.

Test animals

Species:
rat
Strain:
other: Rattus norvegicus CD / Crl: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ORGANISMS: 
- Source: Charles River Deutschland, Sulzfeld
- Strain: Rattus norvegicus CD / Crl: CD(SD)
- approx. 8 weeks
- body weight: 164 - 190 g
- Fasting period before study: 16 hours
- Diet: ad libitum, ssniff R/M-H V 1534
- Water: ad libitum
- Acclimatisation period: at least 5 days
- Temperature (°C): 22 °C +/- 3° C
- Humidity (%): 55% +/- 15 %
- Illumination: 12 hours artifical fluorescent light and 12 hours dark
- Air change: 12 to 18-fold/per hour

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
ADMINISTRATION: 
- Frequency: single dosage on day 1
- Dose volume: 1.77 ml/kg b.w.
- Dose: 2000 mg/kg/bw
- DOSAGE PREPARATION: the substance was used as supplied
The administration volume was 1.77 mL/kg b.w.
- CLASS METHOD: acute-toxic-class methode
first step 3 female rats are treated with 2000 mg/kg b.w., no signs of toxicity were observed
second step (after 24 h) 3 female rats are treated with 2000 mg/kg b.w.
Doses:
2000 mg/kg
No. of animals per sex per dose:
6 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: before administration, immediatly, 5, 10, 30 and 60 min, 3, 6 and 24 h after administration and at least once daily
thereafter, until day 14
- Body weight: days 0 (pre-administration) 7 and 14
- Necropsy: All survived animals were necropsied at the end of the observation period
Statistics:
not required

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No signs of toxicity.
Body weight:
No apparent changes were found in body weight.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Other findings:
no other findings

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Conclusions:
Under the present test conditions, the test item requires no labelling, as LD50 > 2000 mg/kg b.w., p.o.

Executive summary:

The test item is given to female rats by oral administration to obtain information on the toxicity, in particular, lethality of a test item

Under the present test conditions, a single oral administration of 2000 mg test substance to female rats did not reveal any signs of toxicity. No animal died prematurely. All animals gained the expected body weight. No pathological changes were observed at necropsy

Therefore, the test substance is n o n - t o x i c if swallowed, as LD50 > 2000 mg/kg b.w., p.o.