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Registration Dossier
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EC number: 273-708-2 | CAS number: 69011-71-8 A scum formed on the surface of molten aluminum and molten aluminum alloys.
Skin irritation / corrosion
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:
- 2 010
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
- Qualifier:
- according to guideline
- Guideline:
- other: EC 440/2008
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Aluminum, dross
- EC Number:
- 273-708-2
- EC Name:
- Aluminum, dross
- Cas Number:
- 69011-71-8
- Molecular formula:
- not applicable to UVCB substances
- IUPAC Name:
- Aluminum, dross
- 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
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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.
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