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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:
2009-12-03 to 2009-12-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted to current accepted guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
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
Details on test material:
- Name of test material : manganese sulphate monohydrate
- Substance type: extremely pale pink powder
- Physical state: solid
- Analytical purity: Not reported
- Impurities (identity and concentrations): H2O at 105 °C 0.85 %
- Composition of test material, percentage of components: Mn 32.1 %
- Purity test date: 24/09/08
- Lot/batch No.: 08729
- Storage condition of test material: 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
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.28 to 2.64 kg
- Housing: Individually housed in suspended cages.
- Diet: 2030 Teklad Global Rabbit diet (Harlan Teklad, Blackthorn, Bicester, Oxon, UK) available 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 MATERIAL
- Amount(s) applied : 0.5 g moistened sufficiently with 0.5 mL of distilled water to achieve a paste
Duration of treatment / exposure:
Animal 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 material was introduced 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 material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours post administration of test material.


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

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
of three animals
Time point:
other: 24 and 72 hours post dosing
Score:
0
Max. score:
8
Reversibility:
other: Not applicable, no effects noted during the study.
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
68702
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
68703
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
68704
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
68702
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
68703
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
68704
Time point:
24/48/72 h
Score:
0
Max. score:
0
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 material.

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

 

Preparation

pH Measurement

immediately

after 10 minutes

after 20 minutes

 10 % w/w aqueous preparation of the test material

 6.2

6.9

6.9 

Table 1: Individual Skin Reactions

 

Skin Reaction

Observation Time (Following Patch Removal)

Individual Scores – Rabbit Number and Sex

Total

68702 Male

68703 Male

68704 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

68702 Male

2.28

2.33

0.05

68703 Male

2.64

2.65

0.01

68704 Male

2.28

2.31

0.03

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
MnSO4 is not irritating to skin.