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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
RAL 3.0 do not cause skin sensitation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
As part of the available skin sensitisation study, a preliminary irritation study was conducted (NOTOX, 1998). The scores for erythema and edema were zero at both time points for all tested concentrations.
Adequacy of study:
key study
Study period:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, unpublished report available, no restrictions, fully adequate for assessment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 sensitisation: in vivo (non-LLNA)
Remarks:
RAL 3.0 do not cause skin sensitation
Type of information:
experimental study
Remarks:
As part of the available skin sensitisation study, a preliminary irritation study was conducted (NOTOX, 1998). The scores for erythema and edema were zero at both time points for all tested concentrations.
Adequacy of study:
weight of evidence
Study period:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, unpublished report available, no restrictions, fully adequate for assessment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:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Acceptable guinea pig maximisation test that followed sound scientific principles.
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
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles river, Germany
- Age at study initiation: 5 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
Route:
intradermal and epicutaneous
Concentration / amount:
intradermal injection: 10%
epidermal induction: 50%
Challenge: 50%
Adequacy of induction:
not specified
Route:
intradermal and epicutaneous
Vehicle:
CMC (carboxymethyl cellulose)
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Concentration / amount:
- Induction:
intradermal injection: 10%
epidermal induction: 50%

- Challenge: 50%
Adequacy of challenge:
not specified
Route:
epicutaneous, occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Adequacy of challenge:
not specified
No. of animals per dose:
10
Details on study design:
The test substance concentrations selected for the main study were based on the results of a preliminary study.
In the main study, ten experimental animals were intradermally injected with a 10% concentration and epidermally exposed to a 50% concentration (for 48 hours). Five control animals were similarly treated, but with the vehicle (1% aqueous carboxymethyl cellulose) only. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged (epidermal exposure) with a 50% test substance concentration and the vehicle using a dressing (24 hours exposure). At 24 and 48 hours after removal of the dressing, the treated sites were assessed for challenge reactions.

Mortality/viability was checked twice daily.
Toxicity was checked at least once daily.
Body weights were determined prior to start and at termination of the study.
Challenge controls:
yes (negative controls)
Positive control substance(s):
no
Reading:
other: challenge
Group:
positive control
Remarks on result:
other: Positive control results not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.

No evidence was obtained that cryolite had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitisation rate of 0 per cent.


After intradermal injection with 10% cryolite, erythema grade 3 was observed. Epidermal exposure resulted in grade 1 erythema in 2/8 animals. No skin reactions were evident after the challenge exposure in the experimental and control animals.


No mortality occurred and no symptoms of systemic toxicity were observed. In addition, no effects on body weight (gain) were reported.

Interpretation of results:
GHS criteria not met
Remarks:
No mortality occurred and no symptoms of systemic toxicity were observed. In addition, no effects on body weight (gain) were reported
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 sesitising for skin. No adverse health effects have been reported in RAL 3.0 product preparation workers or in those using this product.
Executive summary:

No evidence was obtained that cryolite had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitisation rate of 0 per cent.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Acceptable guinea pig maximisation test that followed sound scientific principles.

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles river, Germany
- Age at study initiation: 5 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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Concentration / amount:
- Induction:
intradermal injection: 10%
epidermal induction: 50%
- Challenge: 50%
Adequacy of induction:
not specified
Route:
intradermal and epicutaneous
Vehicle:
CMC (carboxymethyl cellulose)
Adequacy of induction:
not specified
Challengeopen allclose all
Route:
epicutaneous, occlusive
Concentration / amount:
- Induction:
intradermal injection: 10%
epidermal induction: 50%

- Challenge: 50%
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Adequacy of challenge:
not specified
No. of animals per dose:
10
Details on study design:
The test substance concentrations selected for the main study were based on the results of a preliminary study.
In the main study, ten experimental animals were intradermally injected with a 10% concentration and epidermally exposed to a 50% concentration (for 48 hours). Five control animals were similarly treated, but with the vehicle (1% aqueous carboxymethyl cellulose) only. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged (epidermal exposure) with a 50% test substance concentration and the vehicle using a dressing (24 hours exposure). At 24 and 48 hours after removal of the dressing, the treated sites were assessed for challenge reactions.

Mortality/viability was checked twice daily.
Toxicity was checked at least once daily.
Body weights were determined prior to start and at termination of the study.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: challenge
Group:
positive control
Remarks on result:
other: Positive control results not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: : Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
No mortality occurred and no symptoms of systemic toxicity were observed. In addition, no effects on body weight (gain) were reported.
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 sesitising for skin.
No adverse health effects have been reported in RAL 3.0 product preparation workers or in those using this product.
Executive summary:

No evidence was obtained that cryolite had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitisation rate of 0 per cent.