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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
RAL 3.0 is not irrtating for eyes
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
For eye irritation, a primary eye irritation study was available (Raltech Scientific Services, 1981b). Based on both the mean and individual scores, cryolite is not considered irritating to the eyes.
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline study, limitations in reporting but otherwise 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:
eye irritation: in vivo
Type of information:
experimental study
Remarks:
For eye irritation, a primary eye irritation study was available (Raltech Scientific Services, 1981b). Based on both the mean and individual scores, cryolite is not considered irritating to the eyes.
Adequacy of study:
weight of evidence
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: : Non-guideline study, limitations in reporting but otherwise 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:
Primary eye irritation study
GLP compliance:
no
Specific details on test material used for the study:
Kryocide Insecticide: NB 84-146-2B
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Young adult rabbits (approximately 14 weeks of age) of the New Zealand White strain were maintained individually in screen bottom cages in temperature and humidity controlled quarters, provided continuous access to commercial laboratory feed and water, and held for acclimation period of at least 7 days.
Vehicle:
unchanged (no vehicle)
Controls:
other: the contra-lateral eye serving as the untreated control
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
The treated eyes of group II animals (n=3) were flushed for one minute with lukewarm water, starting 30 seconds after test material administration.
The eyes of group I rabbits remained unflushed.
Observation period (in vivo):
24, 48, 72 and 96 hours and 7 days after treatment
Number of animals or in vitro replicates:
9
Details on study design:
Nine acclimated animals were chosen at random for the test. The animals' eyes were examined using fluorescein dy procedures at least 24 hours before compound administration. Only those animals with no sign of corneal injury were used. Animals were divided into two groups: group I with six rabbits and group II with three rabbits.

Each animal received 0.1 g of the finely ground solid sample placed on the everted lower lid of one eye, with the contra-lateral eye serving as the untreated control. The upper and lower lids were gently held together for one second to prevent loss of material and then released, the treated eyes of group II animals were flushed for one minute with lukewarm water, starting 30 seconds after test material administration. The eyes of group I rabbits remained unflushed.

The treated eyes of both groups were observed for ocular lesions at 24, 48, 72 and 96 hours and at 7 days after treatment. At the 72 hour and 7 day readings, sodium fluorescein and ultraviolet light were used to aid in revealing possible corneal injury. Irritation was graded and scored according to the Draize technique.

Animals were weighed before compound administration and at weekly intervals during the study. At study termination all animals were euthanatized and discarded.
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
24 h
Score:
5.3
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
48 h
Score:
2.7
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
72 h
Score:
0.7
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
other: 96 hours
Score:
0.5
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
7 d
Score:
0
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.06
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.94
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.36
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Group I (flushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
24 h
Score:
3.7
Remarks on result:
other: Group II (flushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
48 h
Score:
2
Remarks on result:
other: Group II (flushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
72 h
Score:
1.3
Remarks on result:
other: Group II (flushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
other: 96 h
Score:
0
Remarks on result:
other: Group II (flushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
7 d
Max. score:
0
Remarks on result:
other: Group II (flushed)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Group II (flushed)
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: Group II (flushed)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.94
Max. score:
3
Reversibility:
fully reversible within: 96 hours
Remarks on result:
other: Group II (flushed)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Group II (flushed)
Interpretation of results:
GHS criteria not met
Remarks:
GHS criteria not met Cryolite is not irritating to the eyes
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 eyes. 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 eyes, 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:
Primary eye irritation study
GLP compliance:
no

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:
Kryocide Insecticide: NB 84-146-2B

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Young adult rabbits (approximately 14 weeks of age) of the New Zealand White strain were maintained individually in screen bottom cages in temperature and humidity controlled quarters, provided continuous access to commercial laboratory feed and water, and held for acclimation period of at least 7 days.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the contra-lateral eye serving as the untreated control
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
The treated eyes of group II animals (n=3) were flushed for one minute with lukewarm water, starting 30 seconds after test material administration.
The eyes of group I rabbits remained unflushed
Observation period (in vivo):
24, 48, 72 and 96 hours and 7 days after treatment
Number of animals or in vitro replicates:
9
Details on study design:
Nine acclimated animals were chosen at random for the test. The animals' eyes were examined using fluorescein dy procedures at least 24 hours before compound administration. Only those animals with no sign of corneal injury were used. Animals were divided into two groups: group I with six rabbits and group II with three rabbits.
Each animal received 0.1 g of the finely ground solid sample placed on the everted lower lid of one eye, with the contra-lateral eye serving as the untreated control. The upper and lower lids were gently held together for one second to prevent loss of material and then released, the treated eyes of group II animals were flushed for one minute with lukewarm water, starting 30 seconds after test material administration. The eyes of group I rabbits remained unflushed.

The treated eyes of both groups were observed for ocular lesions at 24, 48, 72 and 96 hours and at 7 days after treatment. At the 72 hour and 7 day readings, sodium fluorescein and ultraviolet light were used to aid in revealing possible corneal injury. Irritation was graded and scored according to the Draize technique.
Animals were weighed before compound administration and at weekly intervals during the study. At study termination all animals were euthanatized and discarded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
24 h
Score:
5.3
Max. score:
0
Reversibility:
not specified
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
48 h
Score:
2.7
Reversibility:
not specified
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
72 h
Score:
0.7
Reversibility:
not specified
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
other: 96 hours
Score:
0.5
Reversibility:
not specified
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
7 d
Score:
0
Reversibility:
not specified
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.06
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.94
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.36
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
24 h
Score:
3.7
Reversibility:
not specified
Remarks on result:
other: Group II (flushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
48 h
Score:
2
Reversibility:
not specified
Remarks on result:
other: Group II (flushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
72 h
Score:
1.3
Max. score:
0
Reversibility:
not specified
Remarks on result:
other: Group II (flushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
other: 96 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
other: Group II (flushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
other: Group II (flushed)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Group II (flushed)
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: Group II (flushed)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.24
Max. score:
3
Reversibility:
fully reversible within: 96 hours
Remarks on result:
other: Group II (flushed)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Group II (flushed)
Irritant / corrosive response data:
The data do not indicate that the substance is an eye irritating substance. Moreover, 0.1 g was administered which is an excess compared to the prescribed amount in current guidelines (0.1 ml).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Cryolite is not irritating for eyes
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 eyes.
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 eyes, based on the available data.