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Toxicological information

Skin irritation / corrosion

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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:
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Sponsor's identification : MnO2
Appearance : black powder
Date received : 08 September 2008
Storage conditions : room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
68623 Male
Basis:
mean
Time point:
other: mean score for 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
erythema score
Remarks:
68624 Male
Basis:
mean
Time point:
other: mean score for 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
erythema score
Remarks:
68663 Male
Basis:
mean
Time point:
other: mean score for 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Remarks:
68623 male
Basis:
mean
Time point:
other: mean score for 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Remarks:
68624 male
Basis:
mean
Time point:
other: mean score for 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Remarks:
68663 Male
Basis:
mean
Time point:
other: mean score for 24, 48 and 72 hours
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.