RAL 3.0

Skin irritation / corrosion

Some information in this page has been claimed confidential.

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Remarks:

One primary dermal irritation study is available (Raltech Scientific Services, 1981). The primary irritation index and the scores for erythema and edema were zero at both time points for both intact and abraded skin.Cryolite was not irritating to the skin

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant, preliminary irritation study (part of skin sensitisation study), adequate for assessment

Cross-reference

Reason / purpose for cross-reference:

read-across source

Remarks:

The read-across can be performed because trisodium hexafluoroaluminate is component parts of RAL 3.0, and is the only component with possible negative effects for human health

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Remarks:

One primary dermal irritation study is available (Raltech Scientific Services, 1981). The primary irritation index and the scores for erythema and edema were zero at both time points for both intact and abraded skin.Cryolite was not irritating to the skin

Adequacy of study:

weight of evidence

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant, preliminary irritation study (part of skin sensitisation study), adequate for assessment

Reason / purpose for cross-reference:

read-across source

Remarks:

The read-across can be performed because trisodium hexafluoroaluminate is component parts of RAL 3.0, and is the only component with possible negative effects for human health

Qualifier:

no guideline followed

Principles of method if other than guideline:

Preliminary irritation study (part of skin sensitisation study)

GLP compliance:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): cryolite
- Physical state: off white solid
- Analytical purity: > 95%
- Lot/batch No.: 230298
- Storage condition of test material: at room temperature in the dark

Species:

guinea pig

Strain:

Dunkin-Hartley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles river, Germany
- Age at study initiation: 5-9 weeks
- Weight at study initiation: under 500 grams
- Housing: in air conditioned rooms
- Diet: free acces to standard guinea pig diet
- Water: free acces to tap water, diluted with decalcified water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: aqueous carboxymethyl cellulose

Controls:

no

Amount / concentration applied:

50%, 20%, 10%, 5%

Duration of treatment / exposure:

24 hours

Observation period:

24 and 48 hours

Number of animals:

4 (2 animals/concentration; 2 concentrations/animal)

Details on study design:

The epidermal irritancy of cryolite was investigated to select test substance concentrations suitable for the induction and challenge phase in a guinea pig maximisation test.

Epidermal application:
A series of four test substance concentrations was used; the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 ml each) per animal to the clipped flank, using Metalline patches# (2x3 cm) mounted on Medical tape, which were held in place with Micropore tape and subsequently Coban elastic bandage.
After 24 hours, the dressing was removed and the skin cleaned of residual test substance. The treated skin areas were assessed for irritation 24 and 48 hours after exposure.

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose

Irritant / corrosive response data:

No signs of irritation were observed to the highest test substance concentration tested in the preliminary irritation study.

Interpretation of results:

GHS criteria not met

Remarks:

GHS criteria not met Cryolite is not irritating to the skin.

Conclusions:

The only hazardous component of RAL 3.0 is trisodium hexafluoroaluminate. It is present in amounts less than 1%. Because of this the preparation is not irritating for the skin.. No adverse health effects have been reported in RAL 3.0 product preparation workers or in those using this product.

Executive summary:

For Cryolite,in accordance to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for skin, based on the available data.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Preliminary irritation study (part of skin sensitisation study)

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

impurity

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Cryolite
- Substance type: slighty coloured powder
- Analytical purity: 96.9%
- Composition of test material, percentage of components: Na 31%, Al 12.6%, F 53.3%
- Storage condition of test material: room temperature

Specific details on test material used for the study:

- Name of test material (as cited in study report): cryolite
- Physical state: off white solid
- Analytical purity: > 95%
- Lot/batch No.: 230298
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles river, Germany
- Age at study initiation: 5-9 weeks
- Weight at study initiation: under 500 grams
- Housing: in air conditioned rooms
- Diet: free acces to standard guinea pig diet
- Water: free acces to tap water, diluted with decalcified water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: aqueous carboxymethyl cellulose

Controls:

no

Amount / concentration applied:

50%, 20%, 10%, 5%

Duration of treatment / exposure:

24 h

Observation period:

24 -48 h

Number of animals:

4 (2 animals/concentration; 2 concentrations/animal)

Details on study design:

The epidermal irritancy of cryolite was investigated to select test substance concentrations suitable for the induction and challenge phase in a guinea pig maximisation test.

Epidermal application:
A series of four test substance concentrations was used; the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 ml each) per animal to the clipped flank, using Metalline patches# (2x3 cm) mounted on Medical tape, which were held in place with Micropore tape and subsequently Coban elastic bandage.
After 24 hours, the dressing was removed and the skin cleaned of residual test substance. The treated skin areas were assessed for irritation 24 and 48 hours after exposure.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose

Results 3

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose

Irritant / corrosive response data:

No signs of irritation were observed to the highest test substance concentration tested in the preliminary irritation study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Cryolite is not irritating to the skin.

Conclusions:

The only hazardous component of RAL 3.0 is trisodium hexafluoroaluminate. It is present in amounts less than 1%. Because of this the preparation is not irritating for the skin..
No adverse health effects have been reported in RAL 3.0 product preparation workers or in those using this product.

Executive summary:

For Cryolite,in accordance to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for skin, based on the available data.