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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch no.: ZH 291 A1 Fr.2-4
- Expiration date of the lot/batch: 2018-08

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature





Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: young adults, ~10 weeks
- Weight at study initiation:
Group 1: 175.0 ±3.00 g
Group 2: 177.3 ±3.06 g
- Fasting period before study: Feed ~16 h before administration
- Housing: single housing in Makrolon cage, type III
- Diet: ad libitum, VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: ad libitum, tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): ~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: 2.08 mg/kgbw

CLASS METHOD:
- Rationale for the selection of the starting dose: request of the sponsor
Doses:
2000 mg/kg bw
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 and weighing: Individual body weights shortly before administration (day 0), weekly thereafter (d7) and on the last day of observation (d14).
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, body weight

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 was observed.
Clinical signs:
No clinical signs were observed.
Body weight:
All animals of group 1 showed a normal growth rate. In group 2, a decreased growth rate was observed in 2 out of 3 animals in the second week after administration. This effect was observed at times when the female rats have already reached slow growth age.
Gross pathology:
There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met