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Description of key information

In a GLP compliant acute oral toxicity study, performed according to OECD guideline 423, the test item was administered to two groups of 3 female Wister rats at a single dose level of 2000 mg/kg bw. No mortalities or clinical signs were noted. In conclusion, the LD50 of the test item is determined to be> 2000 mg/kg body weight by oral route in the rat.


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:
from 2012-07-23 to 2012-12-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study conducted in compliance with international standard guidelines under GLP conditions. The study report was well documented with all mandatory information included.
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: 12 NohSan N° 8147, JMAFF 2002
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
2012-09-07
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: The bodyweights fell within an interval of ±20% of the mean initial bodyweight of the first treated group (from 159 g to 173 g)
- Fasting period before study: Yes
- Housing: in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK
- Water (e.g. ad libitum): free access to mains drinking
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): fifteen changes per hour
- Photoperiod (hrs dark / hrs light): the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

IN-LIFE DATES: From: 20 September 2012 To: 18 October 2012
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
For the 2000 mg/kg dose level:
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): No data
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on results of available data
Doses:
2000 mg/kg
No. of animals per sex per dose:
6 per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
+ Observations: The first day: 0.5h, 1h, 2h, 4h and then once daily
+ Weighing: day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy
Statistics:
No statistics were performed
Preliminary study:
not applicable
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
other: No signs of systemic toxicity were noted.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
No data

Table 1 Individual Bodyweights and Weekly Bodyweight Changes

 

Dose Level

mg/kg

Animal Number

and Sex

Bodyweight (g) at Day

Bodyweight Gain (g) During Week

0

7

14

1

2

2000

1-0

Female

163

179

187

16

8

1-1

Female

161

176

193

15

17

1-2

Female

173

190

205

17

15

2-0

Female

167

189

220

22

31

2-1

Female

159

191

202

32

11

2-2

Female

169

193

216

24

23

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
Executive summary:

In a GLP compliant acute oral toxicity study, performed according to OECD guideline 423, the test item was administered to two groups of 3 female Wister rats at a single dose level of 2000 mg/kg bw. No mortalities or clinical signs were noted.

In conclusion, the LD50 of the test item is determined to be> 2000 mg/kg body weight by oral route in the rat.


Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw
Quality of whole database:
Only one study available with a good reliability (K1) performed in 2012 following GLP.

Additional information

In a GLP compliant acute oral toxicity study, performed according to OECD guideline 423, the test item was administered to two groups of 3 female Wister rats at a single dose level of 2000 mg/kg bw. No mortalities or clinical signs were noted. In conclusion, the LD50 of the test item is determined to be> 2000 mg/kg body weight by oral route in the rat.


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

Justification for classification or non-classification

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