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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 - 25 Apr 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 2001
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Slovenská národná akreditačná služba, Bratislava, Slovenska Republika
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Slovak Academy of Sciences Dobrá Voda, Slovak Republic
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 184 - 191 g
- Fasting period before study: animals were fasted prior to dosing
- Housing: 3 animals per cage were housed in plastic cages suspended on stainless steel racks
- Diet: ssniff (Spezialdiäten GmbH, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.85 ± 0.59
- Humidity (%): 54.53 ± 3.30
- Air changes: central air conditioning
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 06 Apr 2018 To: 25 Apr 2018

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
DOSAGE PREPARATION: The required amount of the test item (according to the body weight and dose) was administered undiluted considering the composition (i.e., the dose was adjusted to the concentration of the main constituents by applying a correction factor). The administration volume was 0.127 mL x correction factor / 100 g of body weight.

CLASS METHOD
- Rationale for the selection of the starting dose: A limit dose of 2000 mg/kg body weight was used as a starting dose.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 each step
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually immediately after administration of the test item and 0.5, 1, 2 and 4 hours later. Each animal was inspected daily for the next 14 days. Individual weights of animals were measured immediately prior to administration of the test item and weekly thereafter.
- Necropsy of survivors performed: Yes, all test animals were subjected to gross necropsy.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Gross pathology:
Necropsy revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008