Calcium dihydroxide precipitated with carbon dioxide during sugar juice purification

Acute Toxicity: oral

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

Test material information

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:

other: No signs of systemic toxicity were noted during 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.