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Diss Factsheets

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japan MAFF 8147
Version / remarks:
2000
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Bioassay - Labor für biologische Analytik GmbH, Im Neuenheimer Feld 515-519; 69120 Heidelberg
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Crl:WI (Han) SPF
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Young adult animals (female animals approx. 10-11 weeks)
- Weight at study initiation: 183-188 g
- Fasting period before study: at least 16 hours before administration
- Housing: Single housing, in Makrolon cages, type III with wooden gnawing blocks
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days before administration
- Microbiological status: SPF

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3
- Humidity (%): 30-70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.27 mL/kg bw

CLASS METHOD:
- Rationale for the selection of the starting dose:
1st experiment: 2000 mg/kg bw as the limit dose
2nd experiment: Because no mortality occurred in the first experiment, a further dose of 2000 mg/kg bw was administered to another group of 3 female animals in the second step.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 females in the 1st experiment and 3 females in the 2nd experiment
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body weights: Shortly before administration (day 0), weekly thereafter and on the last day of observation.
Clinical observations: Several times on the day of administration and at least once during each workday thereafter.
A check for any dead or moribund animals was made at least once each workday.
- Necropsy of survivors performed: Yes
Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations.
Statistics:
not performed

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occurred.
Clinical signs:
Clinical signs in the first 2000 mg/kg bw test group revealed in all animals impaired general state and piloerection from hour 2 until hour 3 or 5 after administration.
Clinical signs in the second 2000 mg/kg bw test group revealed in all animals salivation at hour 0 after administration only.
Body weight:
All animals gained weight in a normal range throughout the study period.
Gross pathology:
There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met