Reaction mass of copper oxide and manganese dioxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 October 2009 to 13 November 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 dioxide

EC Number:

215-202-6

EC Name:

Manganese dioxide

Cas Number:

1313-13-9

Molecular formula:

MnO2

IUPAC Name:

Manganese dioxide

Test material form:

solid: particulate/powder

Details on test material:

Sponsor's identification : MnO2
Purity : 97.6%
Batch number : 103721-02
Description : black powder
Date received : 8 September 2008
Storage conditions : 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
- Weight at study initiation: 2.33 to 2.67 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: Free access to food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study
- Water: Free access to mains drinking water was allowed throughout the study
- Acclimation period: an acclimatisation period of at least five days

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

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: tets material moistened with 0.5 mL distilled water to achieve a paste

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of test material
- Concentration: At each test site a quantity of 0.5 g of the test material, moistened sufficiently with 0.5 mL of distilled water to achieve a paste

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm cotton gauze
- Type of wrap if used: a strip of surgical adhesive tape

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

SCORING SYSTEM:
Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

68623 Male

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 2

Irritation parameter:

erythema score

Remarks:

68624 Male

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 3

Irritation parameter:

erythema score

Remarks:

68663 Male

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 4

Irritation parameter:

edema score

Remarks:

68623 male

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 5

Irritation parameter:

edema score

Remarks:

68624 male

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 6

Irritation parameter:

edema score

Remarks:

68663 Male

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Irritant / corrosive response data:

The individual scores for erythema/eschar and oedema are given in Table 1 (all tables are in the any other information on results section). Black staining of the fur was noted at all treated skin sites. No evidence of skin irritation was noted during the study.

Other effects:

Individual bodyweights and bodyweight changes are given in Table 2. All animals showed expected gain in bodyweight during the study.

Any other information on results incl. tables

Table 1: Individual Skin Reactions

Skin Reaction	Observation (following patch removal)	Individual Scores – Rabbit Number and Sex			Total
		68623Male	68624Male	68663Male
Erythema/Eschar Formation	Immediately	0STA	0STA	0STA	(0 )
	1 Hour	0STA	0STA	0STA	( 0 )
	24 Hours	0STA	0STA	0STA	0
	48 Hours	0STA	0STA	0	( 0 )
	72 Hours	0STA	0STA	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 used for calculation of primary irritation index

STA = Black staining of the fur

Table 2: Individual Bodyweights and Bodyweight Changes

Rabbit Number and Sex	Individual Bodyweight (kg)		Bodyweight Change (kg)
	Day 0	Day 3
68623Male	2.33	2.43	0.10
68624Male	2.33	2.45	0.12
68663Male	2.67	2.84	0.17

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was not considered to be an irritant under the conditions of the study.

Executive summary:

The skin irritation potential of the test material 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 material was therefore concluded to be a non-irritant.