Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: EC 440/2008
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Al2O3 40% (15 – 50%), Al-met 25% (5 – 40%), AlN 15% (10 – 25%), MgO 8.5% (6 – 10%), CaCO3 4% (2 – 7%), NaCl 1% (0.3 – 2%), KCl 1% (0.3 – 2%), Mn-met 0.13% (0.02 – 0.25%), Fe-met 0.12% (0.02 – 0.2%)
Storage Conditions: at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental 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. 1110), 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:
occlusive
Preparation of test site:
other: the fur was removed from the dorsal area of the trunk by using an electric clipper
Vehicle:
other: Cottonseed oil
Amount / concentration applied:
A dose of 0.5 g of the test item was applied to each test site.
Duration of treatment / exposure:
The test item was held in contact with the skin throughout a 4-hour period.
At the end of the exposure period, the residual test item was removed with cottonseed oil.
Observation period:
All animals were observed for 72 hours.
Number of animals:
3 female

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Total Mean Value
Time point:
other: 24,48,72h
Max. score:
0
Reversibility:
fully reversible within: 48h
Remarks on result:
other: slightly irritant effects
Irritation parameter:
edema score
Basis:
mean
Remarks:
Total Mean Value
Time point:
other: 24, 48, 72 h
Score:
>= 0
Remarks on result:
other: no clinical signs
Irritation parameter:
other: hyperplasia, scaling, discolouration, fissures and scabs or any systemic effects
Basis:
mean
Time point:
other: 24, 48, 72h
Remarks on result:
other: no clinical signs

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 present study, the single dermal application of the test item ALUFLUX or Aluminium dross or gray Aluminium dross to rabbits at a dose of 0.5 g showed slightly irritant effects, which were fully reversible within 48 hours.
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 ALUFLUX or Aluminium dross or gray Aluminium dross does not have to be classified and has no obligatory labelling requirement for skin irritation.
Executive summary:

Under the conditions of the present study, the single dermal application of the test item ALUFLUX or Aluminium dross or gray Aluminium dross to rabbits at a dose of 0.5 g showed slightly irritant effects, which were fully reversible within 48 hours. 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 ALUFLUX or Aluminium dross or gray Aluminium dross does not have to be classified and has no obligatory labelling requirement for skin irritation.