Registration Dossier

Administrative data

Description of key information

Oral: LD50= LD50 cut-off > 5000mg/kg bw, female rat, OECD TG 420, 2016

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:
2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Guideline study performed under GLP. All relevant validity criteria were met.
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
inspected June 2015; signature: September 2015
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Recognised supplier- Age at study initiation: 8 - 12 weeks.- Weight at study initiation: 195 g (sighting test; sentinel); 176 - 198 g (main study); The weight variation did not exceed ±20% of the mean weight.- Fasting period before study: Overnight before dosing and three to four hours after dosing.- Housing: Group housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.- Diet (e.g. ad libitum): Certified diet from recognised supplier, provided ad libitum (except for fasting period).- Water (e.g. ad libitum): ad libitum (except for fasting period)- Acclimation period: At least 5 days.ENVIRONMENTAL CONDITIONS- Temperature (°C): 19 - 25- Humidity (%): 30 - 70%- Air changes (per hr): > 15 air changes per hour - Photoperiod: 12 h light / 12 h darkIN-LIFE DATES: From: To: 2015-10-21 to 2015-11-11
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.The initial starting dose was chosen using available information on toxicity. For the purpose of the 2000 mg/kg dose level, the test item was used as supplied. The 2000 mg/kg bw dose level was treated stepwise. Singuarly and in the absence of mortality or evident toxicity a further group of 4 was tested.
Doses:
2000 mg/kg bw (initial sighting test and main study)
No. of animals per sex per dose:
1 (sighting study) and 4 (main study); total 5 per dose.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days- Frequency of observations and weighing: Clinical observations were made 0.5, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.- Necropsy of survivors performed: yes
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
2000 mg/kg bw: No mortality.
Clinical signs:
2000 mg/kg bw: No signs of systemic toxicity were noted.
Body weight:
2000 mg/kg bw: All animals showed expected bodyweight gains over the study period.
Gross pathology:
2000 mg/kg bw: No abnormalities were noted at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the oral LD50 was established to exceed 2000 mg/kg bw in female Wistar rats. Under the conditions of this study, and according to the OECD TG 420 criteria, the LD50 cut-off value was considered to be greater than 5000 mg/kg body weight.
Executive summary:

The study was performed according to OECD TG 420 and EU Method B.1 bis Acute Toxicity (Oral) and in accordance with GLP to assess the acute oral toxicity of the test material following a single oral administration in the female Wistar strain rat by the fixed dose method. The test substance was administered by oral gavage in an initial sighting study at 2000 mg/kg. Subsequently a further group of four fasted females was given a single oral dose of test item, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study and gross necropsy performed. There was no mortality during the course of the study. No signs of systemic toxicity were noted in the remaining animals. Animals showed expected gains in bodyweight over the study period and there were no abnormalities noted at necropsy. Under the conditions of this study the oral LD50 was established to exceed 2000 mg/kg bw in female Wistar rat. Under the conditions of this study, and according to the OECD TG 420 criteria, the LD50 cut-off value was considered to be greater than 5000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
5 000 mg/kg bw
Quality of whole database:
The available information as a whole meets the tonnage driven information requirements of REACH..

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

OECD TG 420, 2016 - The study was performed according to OECD TG 420 and EU Method B.1 bis Acute Toxicity (Oral) and in accordance with GLP to assess the acute oral toxicity of the test material following a single oral administration in the female Wistar strain rat by the fixed dose method. The test substance was administered by oral gavage in an initial sighting study at 2000 mg/kg. Subsequently a further group of four fasted females was given a single oral dose of test item, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study and gross necropsy performed. There was no mortality during the course of the study. No signs of systemic toxicity were noted in the remaining animals. Animals showed expected gains in bodyweight over the study period and there were no abnormalities were noted at necropsy. Under the conditions of this study the oral LD50 was established to exceed 2000 mg/kg bw in female Wistar rat. Under the conditions of this study, and according to the OECD TG 420 criteria, the LD50 cut-off value was considered to be greater than 5000 mg/kg body weight.


Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for classification or non-classification

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for acute toxicity.