Manganese carbonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 December 2009 to 6 December 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Manganese carbonate

EC Number:

209-942-9

EC Name:

Manganese carbonate

Cas Number:

598-62-9

Molecular formula:

CH2O3.Mn

IUPAC Name:

manganese(2+) carbonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material : MnCO3
- Substance type: light brown powder
- Physical state: solid
- Analytical purity: Mn 44.8 %
- Impurities (identity and concentrations): MnO2 0.18 %, Insol HCl 20 ppm S total 0.144 %, H2O at 105 °C 1.31 %.
- Purity test date: 24/09/08
- Lot/batch No.: 08793
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Hillcrest, Belton, Loughborough, UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.05 to 2.74 kg
- Housing: Individually housed in suspended cages
- Diet: 2030 Teklad Global Rabbit diet (Harlan Teklad, Blackthorn, Bicester, Oxon, UK) avilable ad libitum
- Water : Mains drinking water available ad libitum
- Acclimation period: Minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): A minimum of 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hour cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST SUBSTANCE
- Amount(s) applied : 0.5 g of test substance sufficiently moistened with 0.5 mL of distilled water to acheive a paste

Duration of treatment / exposure:

Animals were exposed for 4 hours.

Observation period:

Animals were observed for 72 hours for skin reactions

Number of animals:

3 animals in total (1 animal used in the initial test, with a further 2 animals in the main test.)

Details on study design:

TEST SITE
- Area of exposure: The test substance was introduced under a 2.5 cm x 2.5 cm cotton gauze patch
- Type of wrap if used: The trunk of each rabbit was wrapped in an elasticated corset


REMOVAL OF TEST SUBSTANCE
- Washing : Any residual test substance was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours post administration of test substance


SCORING SYSTEM: Draize JH (1959) “Dermal Toxicity” In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Associations of Food and Drug Officials of the United States, Austin, Texas p.46-59

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24 and 72 hours post dosing

Score:

0

Max. score:

8

Reversibility:

other: Not applicable, no effects were noted during the study.

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The scores for erythema and oedema at the 24 and 72-hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test substance.

The test material produced a primary irritation index of 0.0.

Other effects:

Not reported

Any other information on results incl. tables

Measurement of pH

The pH of the test substance was determined prior to commencement of the study and found to be as follows:

 

Preparation	pH Measurement
	immediately	after 10 minutes
10 % w/w aqueous preparation of test substance	7.9	7.9

Table 1: Individual Skin Reactions

Skin Reaction	Observation Time (Following Patch Removal)	Individual Scores – Rabbit Number and Sex			Total
		68706 Male	68707 Male	68708 Male
Erythema/Eschar Formation	Immediately	0	0	0	(0)
	1 Hour	0	0	0	(0)
	24 Hours	0	0	0	0
	48 Hours	0	0	0	(0)
	72 Hours	0	0*	0*	0
Oedema Formation	Immediately	0	0	0	(0)
	1 Hour	0	0	0	(0)
	24 Hours	0	0	0	0
	48 Hours	0	0	0	(0)
	72 Hours	0	0*	0*	0
Sum of 24 and 72-hour Readings (S): 0
Primary Irritation Index (S/6): 0/6 = 0.0
Classification: Non-Irritant

() = total values not included in calculating the primary irritation index

 

Table 2: Individual Bodyweights and Bodyweight Changes

 

Rabbit Number and Sex	Individual Bodyweight (kg)		Bodyweight Change (kg)
	Day 0	Day 3
68706 Male	2.05	2.08	0.03
68707 Male	2.74	2.78	0.04
68708 Male	2.26	2.31	0.05

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin. No corrosive effects were noted.

Executive summary:

The skin irritation potential of the test substance was investigated in vivo in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 404 and EU Method B.4.

During the study no signs of skin irritation were noted at any of the observation points. The test substance was therefore concluded to be a non-irritant.