Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
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

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:
No signs of systemic toxicity were noted during the observation period.
Body weight:
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.
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).