Slags, silicomanganese-manufg.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-11-3 to 2009-11-13

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 methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to valid guidelines and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

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:

Slags, silicomanganese-manufg.

EC Number:

273-733-9

EC Name:

Slags, silicomanganese-manufg.

Cas Number:

69012-33-5

Molecular formula:

UVCB identified to contain the following formulae: Na2O, MgO, Al2O3, SiO2, P2O5, K2O, CaO, TiO2, V2O5, Cr2O3, Fe2O3,BaO, ZrO2, ZnO, SrO, SiMn

IUPAC Name:

Slags, silicomanganese-manufacturing

Details on test material:

- Name of test material : SiMn slag
- Physical state: solid
- Appearance: light grey granules
- 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: 2.45 to 2.61 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:

water

Controls:

no

Amount / concentration applied:

TEST SUBSTANCE
- Amount(s) applied : 0.5 g of test substance sufficiently moistened in 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 substance 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 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

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of three animals

Time point:

other: 24, 48 and 72 hours post dosing

Score:

0

Max. score:

8

Reversibility:

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

Irritant / corrosive response data:

The test substance 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 the test substance	8.1	8.3

   

 

Table 1: Individual Skin Reactions

Skin Reaction	Observation Time (Following Patch Removal)	Individual Scores – Rabbit Number and Sex			Total
		68639 Male	68640 Male	68655 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
68639 Male	2.45	2.54	0.09
68640 Male	2.61	2.65	0.04
68655 Male	2.52	2.64	0.12

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study the test substance was determined to be not classified for skin corrosion and irritation.

Executive summary:

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

During the study, 0.5 g of test substance, sufficiently moistened in 0.5 mL of distilled water to achieve a paste, was applied to the shaved trunk of three male rabbits. The test substance was held in place under a semiocclusive dressing. Four hours following topical administration, any residual test substance was removed by gentle swabbing with cotton wool soaked in distilled water. Skin reaction to treatment was assessed over a period of 72 hours according to the Draize scale.

None of the animals died during the study and all animals gained weight. No erythema or oedema was observed following treatment with the test substance. Therefore, under the conditions of the study the test substance was determined to be not classified for skin corrosion and irritation.