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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 February - 28 February 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Calcium dihydroxide precipitated with carbon dioxide during sugar juice purification
EC Number:
932-124-4
IUPAC Name:
Calcium dihydroxide precipitated with carbon dioxide during sugar juice purification
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Sugar Factory Lime (Wet)
- Analytical purity: 100 % (UVCB)
- Composition of test material, percentage of components: 31% water
- Lot/batch No.: SFL-OC-2013-W1
- Expiration date of the lot/batch: 31 December 2013
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature in the dark

Test animals

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: 8-12 weeks
- Weight at study initiation: 159-169 g
- Fasting period before study: overnight fast
- Housing: housed in groupd of up to four in suspended solid floor polypropylene cages furnished with woodflakes.
- Diet: ad libitum apart from fast period before dosing and 3-4 hours after dosing. Fed 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK
- Water: Mains drinkin gwater ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr):15 minimum
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:7/02/2013-28/02/2013

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 286.3 mg test substance/mL (animal #1) 289.9 mg test substance/mL (animals #2-5)
- Justification for choice of vehicle: Substance already contains around 30 % w/w water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on available toxicity information
Doses:
Animal #1: 2863 mg/kg (equivalent to 1976 mg a.i./kg bw)
Animals # 2-5: 2899 mg/kg bw (equivalent to 2000 mg a.i./kg bw)
No. of animals per sex per dose:
5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations 0.5, 1, 2, 4 hours after dosing then daily for 14 days. Body weights day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: no
Statistics:
Not required

Results and discussion

Preliminary study:
No effects seen at 1976 mg ai/kg bw.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity were noted during the observation period.
Body weight:
All animals showed expected gains in body weight over the observation period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
Not applicable

Any other information on results incl. tables

Individual Body Weights and Body Weight Changes

 

Dose Level

mg/kg

 

Animal Number

and Sex

 

Body Weight (g) at Day

Body Weight Gain (g) During Week

0

7

14

1

2

2000*

1-0 Female

162

180

204

18

24

2-0 Female

159

172

183

13

11

2-1 Female

165

180

192

15

12

2-2 Female

168

183

196

15

13

2-3 Female

169

202

215

33

13

*1976 mg a.i./kg bw for animal 1-0.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 (rat) > 2000 mg a.i./kg bw.
Executive summary:

Five female rats were dosed by gavage with 2000 mg a.i./kg bw SFL in a GLP study performed according to OECD 420. There were no deaths and no signs of systemic toxicity were noted during the 14 day observation period. No abnormalities were noted at necropsy. The LD50 (rat) was estimated to be > 2000 mg a.i./kg bw.