Manganese dichloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-12-03 to 2009-12-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to current guidelines.

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 dichloride

EC Number:

231-869-6

EC Name:

Manganese dichloride

Cas Number:

7773-01-5

Molecular formula:

Cl2Mn

IUPAC Name:

manganese(2+) dichloride

Test material form:

solid: flakes

Details on test material:

- Name of test material (as cited in study report): MnCl2 (Eramet)
- Substance type: light pink solid flakes
- Physical state: solid
- Analytical purity: not provided
- Lot/batch No.: 104896-05
- Expiration date of the lot/batch: not provided
- Date received: 2008-09-08
- Stability under test conditions: not provided
- 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 Ltd. Hillcrest, Belton, Loughborough, UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.32 to 2.72 kg
- Housing: housed individually in suspended cages
- Diet: 2030 Teklad Global Rabbit diet (supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK), available ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23°C
- Humidity: 30-70%
- Air changes: at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): lighting controlled by a time switch to give 12 h of continuous light (06:00 to 18:00) and 12 h of darkness

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g of test material moistened sufficiently with 0.5 mL of distilled water to achieve a paste

Duration of treatment / exposure:

Animals were exposed to the test material for 4 hours.

Observation period:

Observations were made immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later.

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: the test material 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 (if done): any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: four hours after application

SCORING SYSTEM: The test material was classified according to the Draize JH (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association 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:

on 3 animals

Time point:

other: 24 and 72 h

Score:

4

Max. score:

6

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

68699

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

68700

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

68701

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

68699

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

68700

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

The individual scores for erythema/eschar and oedema are given in Table 1.
Well-defined erythema and very slight oedema were noted at one treated skin site at the 24-hour observation with very slight erythema noted at the 48 and 72-hour observations. Slight desquamation was noted at this treated skin site at the 7-day observation.
No evidence of skin irritation was noted at two treated sites during the study.

Other effects:

not reported

Any other information on results incl. tables

Measurement of pH

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

 

Preparation
	immediately	after 10 minutes
10 % w/w aqueous preparation of the test material	7.1	7.2

Table 1: Individual Skin Reactions

 

Skin Reaction	Observation Time (Following Patch Removal)	Individual Scores – Rabbit Number and Sex			Total
		68699 Male	68700 Male	68701 Male
Erythema/Eschar Formation	Immediately	0	0	0	(0)
	1 Hour	0	0	0	(0)
	24 Hours	0	0	2	2
	48 Hours	0	0	1	(1)
	72 Hours	0	0	1	1
	7 Days	0	0	0D	(0)
Oedema Formation	Immediately	0	0	0	(0)
	1 Hour	0	0	0	(0)
	24 Hours	0	0	1	1
	48 Hours	0	0	0D	(0)
	72 Hours	0	0	0	0
	7 Days	0	0	0	(0)
Sum of 24 and 72-hour Readings (S): 4
Primary Irritation Index (S/6): 4/6 = 0.7
Classification: Mild Irritant

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

D = Slight desquamation

 

Table 2: Individual Bodyweights and Bodyweight Changes

 

Rabbit Number and Sex	Individual Bodyweight (kg)		Bodyweight Change (kg)
	Day 0	Day 7
68699 Male	2.40	2.53	0.13
68700 Male	2.72	2.85	0.13
68701 Male	2.32	2.51	0.18

Applicant's summary and conclusion

Interpretation of results:

not irritating

Conclusions:

MnCl2 is not a dermal irritant.

Executive summary:

Introduction:

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

- OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002)

- Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008

Results:

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced well-defined erythema, very slight oedema and slight desquamation at one treated skin site. No evidence of skin irritation was noted at two treated skin sites.

Conclusion:

The test material produced a primary irritation index of 0.7 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.