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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:
3 November 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:
2009
Report Date:
2009

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 : FeMn slag
- Substance type: green/grey solid lumps
- Physical state: solid
- Composition of test material, percentage of components: MnO 34.62 %, SiO2 28.18 %, CaO 20.95 %, Al2O3 10.38 %, MgO 3.41 %, FeO 0.53 %, K2O 0.57 %, TiO2 0.24 %.
- Purity test date: 2-July-2008
- 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 - 20 weeks old
- Weight at study initiation: 2.17 - 2.43 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 - 23 °C
- Humidity (%): 30 - 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 of test material 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 material was introduced under 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 MATERIAL
- 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

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24 and 72 hours post dosing
Score:
0
Max. score:
8
Reversibility:
other: Not applicable, no effects observed during the study.
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.

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

 8.9

 9.6

 9.6

Table 1: Individual Skin Reactions

Skin Reaction

Observation Time (Following Patch Removal)

Individual Scores – Rabbit Number and Sex

Total

68637 Male

68638 Male

68661 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

68637 Male

2.17

2.21

0.04

68638 Male

2.37

2.43

0.06

68661 Male

2.43

2.52

0.09

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin. No corrosive effects were noted.
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.