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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 175.7 - 181.0 g
- Fasting period before study: at least 16 hours
- Housing: single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
deionized
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20g/100ml (2000 mg/kg bw group), 3g/100ml (300 mg/kg bw group)
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: Aqueous preparation corresponds to the physiological medium.
Doses:
2000 mg/kg bw, 300 mg/kg bw
No. of animals per sex per dose:
3 (2 x 3 animals for 300 mg/kg bw group)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter. Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: 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. Necropsy of all animals that died as early as possible after death.
- Other examinations performed: no histological examinations were performed.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD100
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD0
Effect level:
300 mg/kg bw
Based on:
test mat.
Mortality:
All animals of the 2000 mg/kg bw test group died within 5 hours after administration. No mortality occurred in both 300 mg/kg bw test groups.
Clinical signs:
In two animals of the 2000 mg/kg bw test group impaired general state was observed at hour 0, while poor general state was noticed in all animals from hour 0 or 1 until hour 4 after administration. In all animals apathy was observed from hour 0 or 1 until hour 4. Piloerection was noted in all animals from hour 0 until hour 4. One animal showed abdominal position from hour 0 until hour 1, followed by cowering position from hour 2 until hour 4. Another animal showed also cowering position from hour 2 until hour 4 after administration.
In both 300 mg/kg bw test groups no clinical signs were observed during clinical examination.
Body weight:
The body weights of the surviving animals increased within the normal range throughout the study period.
Gross pathology:
The following macroscopic pathologic findings were observed in all animals that died in the 2000 mg/kg bw test group: Red discoloration of the glandular stomach and small intestine, gaseous stomach which was filled with liquid contents and marginal dark discoloration of the liver. There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period (300 mg/kg bw: 6 females).

Any other information on results incl. tables

Mortality

Dose (mg/kg bw):

2000

Sex:

female

Administration:

1

No. of animals:

3

Mortality (animals):

3

 

Mortality

Dose (mg/kg bw):

300

300

Sex:

female

female

Administration:

1

2

No. of animals:

3

3

Mortality (animals):

No mortality

No mortality

 

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under the conditions of this study the median lethal dose of Lithium Perchlorate after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.