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Administrative data

Description of key information

GLP compliant OECD 423: LD50 (oral) > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 14, 2017 - March 28, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at start of study: 9 weeks
- Weight at study initiation: 169 g (range from 159 to 181 g).
- Fasting period before study: approx. 17 - 20 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.0 – 22.8°C
- Humidity (%):39.3 – 58.8%
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regime

IN-LIFE DATES: From: day 1 To: day 15
Route of administration:
oral: gavage
Vehicle:
methylcellulose
Remarks:
Methocel K4M Premium solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: well tolerated and established standard vehicle

MAXIMUM DOSE VOLUME APPLIED: 1 mL/100 g
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg bw: 6 (f)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: day 1, 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
Standard statistical methods have been applied for data processing.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was seen in rats treated with 2000 mg/kg bw.
Clinical signs:
No clinical signs of toxicity were seen.
Body weight:
The body weight development was inconspicuous throughout the study.
Gross pathology:
The gross pathological examination revealed no organ alterations.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, it is concluded that the test item has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw after single oral administration in female rats.
Executive summary:

The objective of the present study was to identify potential toxic effects of the test item after single oral administration to rats in a stepwise procedure.

The study was started with 2000 mg/kg bw in 3 female rats and continued with further 3 females at 2000 mg/kg bw.

Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.

No mortality occurred in the 6 female rats treated with 2000 mg/kg bw.

The body weight development was inconspicuous throughout the study. No clinical signs of toxicity were observed. The gross pathological examination revealed no organ alterations.

Conclusion

Under the conditions of the present study, it is concluded that the test item has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw after single oral administration in female rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
Guideline study under GLP conditions

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the provided information the test item is not classified for acute oral toxicity according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.