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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:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
On 2 occasions the relative humidity exceeded the upper limit of 70 %. This was regarded as not relevant for the relaibility of the study
Principles of method if other than guideline:
guideline used, deviations have no influence on reliability
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Sample: solid powder
Colour: brown
Packing: supplied in an opaque plastic bottle
Arrival: 7th September 1990
Code: Toxicol Laboratories reference number A/S/17630
Storage: in the dark at room temperature
ABS Grain size 0/32 mm (SS-EN 13242 and SS-EN 13285)
Property Method Result
Density EN 13286 2.08 kg/L
Water content EN 13286 6.1 % w/w
S(total) SS-EN 1744-1 1.3 % w/w
sulfate SS-EN 1744-1 ≤ 0.1 % w/w (acid soluble sulfate)

The test material is similar in composition to the following ABS samples:
Acid soluble sulfate ≤ 0.1 % w/w
Start pH 10.7

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
weight of the animals: 3.7, 3.8, 3.9 kg
Rabbits were obtained from Ranch Rabbits, Crawley Down, Sussex. On arrival, animals were identified in the ear with a metal tag stamped with an individual number. Animals were allowed to acclimatize for at least five days.
The day before dosing the dorsal surfaces of the trunk of the rabbits were clipped free of hair using an Oster Model A2 clipper with Angra blade. Three animals with healthy skin were selected for the study.
On the day of dosing the 3 animals were placed in restraining stocks. A 0.5 g aliquot of the test material was placed evenly over a 2.5 cm square of surgical lint. The lint square was placed onto the animal´s skin on the left flank and immediately caudal to the last rib, with the test material in contact with the skin. The test patch was held in position by encircling the trunk of the animal with a length of Elastoplast elastic adhesive bandage 7.5 cm wide. All three animals were treated in this manner and they were then returned to their cages. After four hours the bandages were removed and the treated areas gently cleaned using cotton wool soaked in warm water at 37 °C. The animals were then returned to their cages.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 g/rabbit, skin area 6 cm2
Duration of treatment / exposure:
4
Observation period:
1 h, 24 h, 48 h, 72 h
Number of animals:
3
Details on study design:
The degree of irritation and/or corrosion produced on the intact skin of the albino rabbit following 4 possible route of exposure during manufacture, handling or use of the slag. The rabbit was chosen as the test organism since it is an appropriate mammalian species for simulation of possible effects on human skin.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
0
Max. score:
0
Reversibility:
other: not relevant because no irritation/corrosion occured
Remarks on result:
other: Since no effect occured, observation terminated after 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
0
Max. score:
0
Reversibility:
other: not relevant because no irritation/corrosion occured
Remarks on result:
other: Since no effect occured, observation terminated after 72 h
Irritant / corrosive response data:
No irritation/corrosion observed in any of the animals (all scores 0)
Other effects:
No other effect observed

Any other information on results incl. tables

Classification

The numerical scores obtained in each rabbit on assessing irritation caused by the test material at the twenty four, forty eight, and seventy two hour observations were summed and a mean calculated. The values for erythema and eschar formation remained separate from those obtained on evaluating edema. When the mean value obtained for either erythema or edema equalled or exceeded two, in two or more animals, then the material was considered an irritant.

No irritation/corrosion was observed, and the slag has not to be classified

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Fine-ground slags, ferrous metal, blast furnace (air-cooled - ABS) do not need to be classified, according to the Criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (Regulation (CE) No 1272/2008), the slags do not need to be classified. Neither a signal word nor a hazard statement are required.
Executive summary:
To test the irritative potential of slags, ferrous metal, blast furnace (air-cooled, ABS) to skin, tests were performed following OECD guideline 404. Fine-ground ABS was dosed, in its original form, at 0.5 g/animal under semi-occlusive dressing during 4 h to an undamaged, dorsal skin area of each 6 cm2 of 3 albino rabbits. After dosing, the patches were removed and skin reaction to the test material was assessed after 1 h, 24 h, 48 h, and 72 h. As no irritation was observed during 72 h, observation was terminated.

Slags, ferrous metal, blast furnace (air-cooled - ABS) are neither irritative nor corrosive (Toxicol Laboratories 1990).