Registration Dossier

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Administrative data

Description of key information

Two in vivo studies in which the skin irritation potential of a substance analogue (amphoacetates C12) has been investigated according to OECD 404 are read-across to this substance. Based on the results obtained in the studies, the substance is not classified for skin irritation. 
Four in vivo studies in which the eye irritation potential of a substance analogue (amphoacetates C12) has been investigated are read-across to the registered substance. Based on the results obtained in one of these studies, conducted in accordance with OECD 405 and GLP, the substance needs to be classified for eye irritation. The registered substance has been tested in a concentration not higher than 16% in water and in this study observed effects do not warrant classification.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: Note: solid content of the test material: 50%
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: Note: solid content of the test material: 50%
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: Note: solid content of the test material: 50%
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: Note: solid content of the test material: 50%
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: Note: solid content of the test material: 50%
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: Note: solid content of the test material: 50%
Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritation potential of a related member of amphoacetates C12 has been investigated according to OECD 404 and GLP. On the basis of the obtained results, the test material (solid content 50%) is not classified as a skin irritant according to the criteria of the CLP Regulation. The results are read-acrossed to the registered substance.
Executive summary:

The skin irritation potential of a related member of amphoacetates C12 has been investigated according to OECD 404 and GLP. The test material (aqueous solution at approx. 50% solids) was tested for acute dermal irritation in 3 female New Zealand White rabbits, according to OECD 404/EC method B.4, and in compliance with Good Laboratory Practice. The test material, was applied as such on a gauze, in a single dermal dose of 0.5 g, to a 2.5 x 2.5 cm clipped area of the skin, during 4 hours under a semi-occlusive dressing. The cutaneous examinations were performed at 1, 24, 48 and 72 hours after removal of the dressing. The application of the preparation produced very slight erythema (score 1) in all animals at 24 hours but only in two animals at 48 hours after patch removal. The reversibility was complete at 72 hours in all animals. Very slight edema was observed in all animals but only at 24 hours. No other reactions were observed after. The mean individual scores calculated over the 24-72 hour period for each animal were (0.7-0.7-0.3) for erythema, and (0.3-0.3-0.3) for edema. On the basis of these results, the test material (solid content 50%) is not classified as a skin irritant according to the criteria of the CLP Regulation. These results are read-acrossed to the registered substance.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Remarks:
In vivo study, the study was conducted before validated in vitro methods were available.
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
GLP compliance:
yes
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: solid content of the test material: 50%
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The eye irritation potential of Miranol H2M CONC (amphoacetates C12) has been investigated according to OECD 405 and GLP. On the basis of the obtained results, the test material (solid content 50%) is classified as Irritating to eyes (Category 2) according to the criteria of the CLP Regulation. The data are read-across to the registered substance.
Executive summary:

The eye irritation potential of Miranol H2M CONC (amphoacetates C12) has been investigated according to OECD 405 and GLP. The test material was tested as an aqueous solution at 50% solids for acute ocular irritation in 3 female New-Zealand White rabbits. The test material, was instillated as such in a single dose of 0.1 ml into the conjunctival sac of the right eye of each animal. The left eye remained untreated and served as a control. The eyes were not rinsed. Ocular examinations were performed 1, 24, 48 and 72 hours after the instillation. Slight corneal opacity (grade 1) was observed at 1 hour after instillation in one animal, then between day 1 and 7 in all animals (grade 1 or 2). Iris inflammation (grade 1) was only noted at 1 hour. The mean scores (24-48-72 hours) calculated for each animal were 1.0 - 1.3 - 1.3 for corneal opacity, and 0.0 - 0.0 - 0.0 for iritis. Conjunctival redness and chemosis (grades 2 or 3) was observed in all three animals at 1 hour after instillation, and persisted until 72 hours (grade 1 or 2). These reactions were no longer present at day 7. The mean scores (24-48-72 hours) calculated for each animal were 1.3 - 1.7 - 2.0 for conjunctival redness, and 1.0 - 1.3 - 1.0 for chemosis. The test material (solid content 50%) is classified as irritating to eyes (Category 2) according to the criteria of the CLP Regulation. The data are read-across to the registered substance.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Two in vivo studies in which the skin irritation potential of a substance analogue (amphoacetates C12) has been investigated according to OECD 404 are read-across to the registered substance. On the basis of the obtained results, an aqueous solution of the substance (solid content 50%) is not classified as a skin irritant according to the criteria of the CLP Regulation.

The rationale to read across the data is attached in Section 13.

Eye irritation

Four in vivo studies in which the eye irritation potential of a substance analogue (amphoacetates C12) has been investigated are read across to the registered substance. Based on the results obtained in one of these studies, conducted in accordance with OECD 405 and GLP, the substance needs to be classified for eye irritation. In another study, in which the test material had a similar solid content (and slightly lower surfactant content) effects with a lower intensity, below the classification criteria, were observed.

The rationale to read across the data is attached in Section 13. The registered substance itself has been tested twice, in a concentration not higher than 16% in water and in this study observed effects do not warrant classification.

Justification for classification or non-classification

Based on the current data-set, the substance is not classified for skin irritating or corrosive properties.

Based on the effects seen in one of the four studies conducted with a substance analogue, the registered substance is classified as Irritating to eyes (Category 2) in accordance with the CLP Regulation. Another study with a similar solid content (and slightly lower surfactant content) showed effects with a lower intensity, below the classification criteria.

Based on studies conducted with the registered substance itself, an aqueous solution of the substance at 16% or less does not need to be classified. Therefore a specific concentration limit of >16% is set for the eye irritation hazard of the substance.