Aluminum, dross

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:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EC 440/2008

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

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

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

Results

Results 1

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

Results 2

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

Results 3

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.