Silicomanganese manufacturing fumes dedusting solid residues

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-12-07 to 2009-12-17

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:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Silicomanganese manufacturing fumes dedusting solid residues

EC Number:

930-776-4

IUPAC Name:

Silicomanganese manufacturing fumes dedusting solid residues

Details on test material:

- Name of test material: Mn3O4 (Erachem)
- Substance type: brown powder
- Physical state: Solid
- Impurities (identity and concentrations): K2O (1ppm), Na2O (3ppm), MgO (44ppm), CaO (14ppm), SiO2 (12ppm), S total (0.041%), H2O at 105 °C (0.42%)
- Composition of test material, percentage of components: Mn (71.2%)
- Lot/batch No.: 08100
- Storage condition of test material: room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories U.K. Limited, Hillcrest, Belton, Loughborough, UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.13 to 2.66 kg
- Housing: Animals were housed individually in suspended cages.
- Diet : Free access to 2030 Teklad Global Rabbit diet (Harlan Teklad, Blackthorn, Bicester, Oxon, UK).
- Water : Free access to mains drinking water
- Acclimation period: A minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): At least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour cycle.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 54 mg

Duration of treatment / exposure:

Up to 72 hours

Observation period (in vivo):

Animals were assessed up to 72 hours after exposure (assessments were made at 1, 24, 48 and 72 hours post treatment).

Number of animals or in vitro replicates:

1 animal was initially treated, with a further two animals

Details on study design:

APPLICATION OF TEST SUBSTANCE:
Initially a single rabbit was treated with 54 mg of test material. The test material was administered into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment to prevent loss of test material and then released. The left eye served as a control and remained untreated. Immediately after administration of the test material an assessment of the initial pain reaction was made. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.


SCORING SYSTEM:
Assessment of ocular damage/irritation was made 1, 24, 48 and 72 hours post dosing using the scoring system from Draize JH (1977) “ Dermal and Eye Toxicity Tests” In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p. 48 to 49. Any other ocular effects were also noted at this point along with any clinical signs of toxicity if present. Individual bodyweights were recorded on day 0 and 3. The numerical values corresponding to each animal, tissue and observation time were recorded. These scores were then assessed using a modified version of the system described by Kay JH and Calandra JC (1962), J. Soc. Cosmet. Chem. 13, 281-289. If evidence of irreversible ocular damage is noted, the test material will be classified as corrosive to the eye.


TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

mean

Time point:

other: 24,48, 72 hrs

Score:

ca. 0

Max. score:

4

Reversibility:

other: not applicable as no effects

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

ca. 0

Max. score:

2

Reversibility:

other: not applicable as no effects

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Results 4

Irritation parameter:

other: Redness

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

ca. 1

Max. score:

3

Reversibility:

fully reversible within: 48 hrs

Irritant / corrosive response data:

Moderate conjunctiva irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hr observation. All treated eyes appeared normal at the 48-hr observation

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
10% aqueous preparation of the test material	Immediately	After 10 minutes	After 20 minutes
	6.8	8.8	8.5

Table 1: Individual Scores and Individual Total Scores for Ocular Irritation

 

Rabbit Number and Sex	68654 Male				68673 Male				68674 Male
	IPR = 2				IPR = 2				IPR = 2
Time After Treatment	1 Hr	24 Hrs	48 Hrs	72 Hrs	1 Hr	24 Hrs	48 Hrs	72 Hrs	1 Hr	24 Hrs	48 Hrs	72 Hrs
Cornea
E = Degree of opacity	0	0	0	0	0	0	0	0	0	0	0	0
F = Area of Cornea Involved	0	0	0	0	0	0	0	0	0	0	0	0
Score (E x F) x 5	0	0	0	0	0	0	0	0	0	0	0	0
Iris
D	0	0	0	0	0	0	0	0	0	0	0	0
Score (D x 5)	0	0	0	0	0	0	0	0	0	0	0	0
Conjunctivae
A = Redness	2	1	0	0	2	1	0	0	2	1	0	0
B = Chemosis	2	1	0	0	2	1	0	0	2	1	0	0
C = Discharge	2Sf	1Sf	0Sf	0Sf	2Sf	1Sf	0Sf	0Sf	2Sf	1Sf	0Sf	0Sf
Score (A + B + C) x 2	12	6	0	0	12	6	0	0	12	6	0	0
Total Score	12	6	0	0	12	6	0	0	12	6	0	0

  IPR = Initial pain reaction

Sf = brown-coloured staining of the fur around treated eye

 

Table 2: Individual Total Scores and Group Mean Scores for Ocular Irritation

 

Rabbit Number and Sex	Individual Total Scores At:
	1 Hour	24 Hours	48 Hours	72 Hours
68654 Male	12	6	0	0
68673 Male	12	6	0	0
68674 Male	12	6	0	0
Group Total	36	18	0	0
Group Mean Score	12.0	6.0	0.0	0.0

 

 

Table 3:Individual Bodyweights and Bodyweight Changes

 

Rabbit Number and Sex	Individual Bodyweight (kg)		Bodyweight Change (kg)
	Day 0	Day 3
68654 Male	2.66	2.75	0.09
68673 Male	2.13	2.32	0.19
68674 Male	2.21	2.27	0.06

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Mn3O4 is not an eye irritant.

Executive summary:

This was chosen as Key study as it is the only available study which is of relevance and of sufficient quality for classification and labelling and for risk assessment.

 

The study report includes the entire information requirement as appropriate for OECD 405 (Acute Eye Irritation/Corrosion) and EU Method B.5 guidelines. Therefore the quality criteria of the study have been fulfilled as the study was conducted to guideline and to GLP

 

No corneal or iridial effects was noted during the study. Moderate conjuctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24 -hour observation. . The test material produced a maximum group mean score of 10.0 and the presence of minimal conjunctival reactions enabled classification as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC or the Globally Harmonised Classification system (GHS).