Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2013-9-25 to 2014-01-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Report of study in accordance with OECD guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Batch: 110801
Purity: 99.8%
Test substance storage: At room temperature in the dark under nitrogen
Stable under storage conditions until 26 August 2018 (expiry date)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Approx. 8-9 weeks old
- Weight at study initiation: 159 to 172 (mean=165)g
- Fasting period before study: overnight prior to dosing
- Housing: Group housing of 3 animals per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18 to 24 °C
- Humidity (%): 40 to 70%
- Air changes (per hr): 15 times
- Photoperiod (hrs dark / hrs light): 12-hour light /12-hour dark

IN-LIFE DATES: From: 2013-10-10 To: 2013-10-30

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
Oral gavage, using plastic feeding tubes.
Vehicle: Propylene glycol (Merck, Darmstadt, Germany) (specific gravity 1.036)
Preparation: The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle. No correction was made for purity of the test substance.
Doses:
2000mg/kg (10mg/kg) body weight
No. of animals per sex per dose:
3
Control animals:
yes
Details on study design:
Observations
-Mortality/Viability: Twice daily.
-Body weights Days 1 (pre-administration), 8 and 15.
-Clinical signs At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded.
-Necropsy: At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy.
Descriptions of all internal macroscopic abnormalities were recorded.

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:
Hunched posture and piloerection were noted for most animals between Days 1 and 4.
Body weight:
The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The oral LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.