Calcium dihydroxide precipitated with carbon dioxide during sugar juice purification

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 February - 07 March 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

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:

male/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: males 246-289 g; females 206-228 g
- Fasting period before study:
- Housing: The animals were housed individually during the 24-Hour exposure period and in groups of five, by sex, for the remainder of the study.
- Diet: ad libitum 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK
- Water: ad libitum mains drinking water
- Acclimation period: 5 days minimum

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

IN-LIFE DATES: From: To: 13/02/2013 - 07/03/2013

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks
- % coverage: approximately 10%
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi occluded with a piece of self adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with damp cotton wool
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Equivalent to 2000 mg a.i./kg
- For solids, paste formed: test material was moistened with water

Duration of exposure:

24 h

Doses:

2899 mg/kg (equivalent to 2000 mg a.i./kg body weight)

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual body weights were recorded prior to application of the test item on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: Dermal irritation (on removal of the patch and once daily thereafter)

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

male/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:

Dermal irritation:
Brown coloured staining, not preventing evaluation of skin responses, was noted at the test sites of all animals one day after dosing.
There were no signs of dermal irritation.

Any other information on results incl. tables

Individual Body Weights and Body Weight Changes

 

Dose Level mg a.i./kg	Animal Number and Sex	Body Weight (g) at Day			Body Weight Gain (g) During Week
		0	7	14	1	2
2000	1-0 Male	263	279	300	16	21
	1-1 Male	289	309	342	20	33
	1-2 Male	247	255	272	8	17
	1-3 Male	265	285	309	20	24
	1-4 Male	246	255	276	9	21
	2-0 Female	224	223	232	-1	9
	2-1 Female	211	211	215	0	4
	2-2 Female	215	216	221	1	5
	2-3 Female	206	210	217	4	7
	2-4 Female	228	223	239	-5	16

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2899 mg/kg body weight (equivalent to 2000 mg active ingredient/kg body weight).

Executive summary:

In a GLP study performed according to OECD TG 402 a group of ten animals (five males and five females) was given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2899 mg/kg body weight (equivalent to 2000 mg active ingredient/kg body weight). Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths, signs of systemic toxicity or dermal irritation. Animals showed expected gains in body weight except for three females which showed bodyweight loss or no gain in body weight during the first week with expected gain in bodyweight during the second week. No abnormalities were noted at necropsy. The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2899 mg/kg body weight (equivalent to 2000 mg active ingredient/kg body weight).