Registration Dossier

Administrative data

Description of key information

An in vivo study in which the skin irritation potential of a related member of the chemical category (amphoacetates C12) has been investigated according to OECD 404 are read-across to this substance, member of the same chemical category. Based on the results obtained in the studies, the substance is not classified for skin irritation. 
An in vivo studies in which the eye irritation potential of a related member of the chemical category (amphoacetates C12) has been investigated is read across to this substance, member of the same chemical category. Based on the results, the substance is to be classified for eye irritation.

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:
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: 72 hours
Remarks on result:
other: 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: 72 hrs
Remarks on result:
other: 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: 72 hrs
Remarks on result:
other: 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: 48 hours
Remarks on result:
other: 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: 48 hrs
Remarks on result:
other: 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: 48 hrs
Remarks on result:
other: solid content of the test material: 50%
Interpretation of results:
GHS criteria not met
Remarks:
C
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 across 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 across to the registered substance.

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

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

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 across to the registered substance.

Eye irritation

The eye irritation potential ofMiranol 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.

Justification for classification or non-classification

Based on the current data-set, the registered substance is not classified for skin irritation or corrosion, but is clasified for eye irritant effects (cat. 2) according to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures.