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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 11-16, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study generated according to internationally accepted testing guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Slags, ferronickel-manufg.
EC Number:
273-729-7
EC Name:
Slags, ferronickel-manufg.
Cas Number:
69012-29-9
Molecular formula:
This is a UVCB substance, consisting of oxides of aluminum, iron, magnesium and silicon. Due to the nature of the substance, specific molecular formula is not relevant.
Details on test material:
Slag from Ferronickel Converter containing Iron in the form of the element and its oxides, metalic oxides and Nickel.
Solid / dark brown to grey.
Chemical name: Slags, Ferronickel-manufg.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Species/strain: healthy New Zealand White Rabbits, Crl: KBL (NZW)
Source: Charles River Deutschland, 97633 Sulzfeld, Germany
Sex: female
Body weight at the beginning of the study: > 2kg
Age at the beginning of the study: approximately 15 weeks old
Number of animals: 3
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare the animals were bred for experimental purposes.

Housing and Feeding Conditions
- Semi barrier in an air-conditioned room
- Temperature: 18 3° C (recommendations of TVT [9], GV-SOLAS [10])
- Relative humidity: 55 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 1325), rich in crude fibre
- Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Housed in ABS - plastic rabbit cages, floor 4200 cm2
- Adequate acclimatisation period (at least 5 days)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: electric clipper
Vehicle:
other: Aqua ad injectionem
Controls:
no
Amount / concentration applied:
A dose of 0.5 g of the test item was applied to each test site.
Duration of treatment / exposure:
4h
Observation period:
All animals were observed for 72 hours after the patch removal.
Number of animals:
3
Details on study design:
The test item was not expected to produce corrosion, but might be irritating. Therefore, a single patch was applied to one animal for four hours.
The test item was applied first to a gauze patch at a single dose. To ensure good skin contact, it was moistened with the vehicle. The patch was then applied to the skin on a small area (approx. 6 cm²) on the left side (animals no. 1 and 3) and the right side (animal no. 2) of the dorsal area. The gauze was held in place with non-irritating tape. The corresponding untreated right or left side served as control. The patch was fixed with a semi-occlusive dressing. The limits of the application site were marked with an ink marker.

The test item was held in contact with the skin throughout a 4-hour period.
The results of the initial test did not indicate the test item to be corrosive or a severe irritant to the skin using the procedure described. In order to confirm the response, two additional animals were treated in the same manner.
All animals were observed for 72 hours after the patch removal.
The animals were examined for signs of erythema and oedema 1 hour after the patch removal. For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema 24, 48 and 72 hours after the patch removal. Dermal irritation was scored and recorded according to the grades in the table below (Table 2). Any other signs such as hyperplasia, scaling, discolouration, fissures and scabs or any systemic effects were also recorded.
Individual reactions of each animal were recorded at each time of observation.
Nature, severity and duration of all lesions observed were described.
The body weight development was recorded at the start and at the end of the study.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: "1h, 24h, 48h, 72h"
Score:
0
Max. score:
0
Reversibility:
other: no erythema was observed
Remarks on result:
other: No erythema was observed in any of the test animals for the duration of the test and the observation period
Irritation parameter:
edema score
Basis:
mean
Time point:
other: "1h, 24h, 48h, 72h"
Score:
0
Max. score:
0
Reversibility:
other: no oedema was observed
Remarks on result:
other: no oedema was observed in any of the animals for the duration of the test and the observation period
Irritation parameter:
other: clinical signs
Basis:
mean
Time point:
other: "1h, 24h, 48h, 72h"
Score:
0
Max. score:
0
Reversibility:
other: no clinical signs
Remarks on result:
other: no clinical signs were observed
Irritant / corrosive response data:
The test item showed neither irritant nor corrosive effects on the intact skin of three female rabbits (strain NZW) after a contact time of 4 hours
Other effects:
Neither mortalities nor significant clinical signs of toxicity were observed.
There were no significant body weight changes during the contact and observation period

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the single dermal application of the test item Slags, ferronickel-manufg./Electric Furnace Slag/ Converter Slag to rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects.
Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC [6] and Annex I of Regulation (EC) 1272/2008 [7], the test item Slags, ferronickel-manufg./Electric Furnace Slag/ Converter Slag does not have to be classified and has no obligatory labelling requirement for skin irritation.
Executive summary:

The test for acute dermal irritation/corrosion for the substance is performed on the rabbit.

Under the conditions of the study, the single dermal application of the test item Slags, ferronickel-manufg./Electric Furnace Slag/ Converter Slag to rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects.

Neither mortalities nor significant clinical signs of toxicity were observed.

In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC [6] and Annex I of Regulation (EC) 1272/2008 [7], the test item Slags, ferronickel-manufg./Electric Furnace Slag/ Converter Slag does not have to be classified and has no obligatory labelling requirement for skin irritation.