Registration Dossier

Administrative data

Description of key information

Results for skin and eye irritation were based on the constituent of the target substance with CAS 85186-64 -7

Skin irritation in vivo (similar to OECD 404): not irritating

Eye irritation in vivo (similar to OECD 405): not irritating

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
Justification for type of information:
Please refer to the attached read-across justification
Reason / purpose:
read-across source
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: black test substance residues
Remarks:
Result read-across source CAS No. 85186-64-7.
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: black test substance residues
Remarks:
Result read-across source CAS No. 85186-64-7.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to the attached read-across justification
Reason / purpose:
read-across source
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: black test substance residues
Remarks:
Result read-across source CAS No. 85186-67-4.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
3
Remarks on result:
other: black test substance residues
Remarks:
Result read-across source CAS No. 85186-67-4.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No studies are available with the substance itself, therefore information the constituent with CAS 85186-64 -7 is used.

In vivo skin irritation (similar to OECD 404 with CAS 85186-64 -7)

A pre-guideline study, similar to OECD 404 was performed. In this study 2 Vienna White rabbits were treated with ca. 1g (50% aqueous) test substance on the clipped skin of the upper third of the back. The exposure duration was 20 hours under occlusive conditions. After removal of the test patch, the substance was not removed. Observations were recorded after 24 hours and 8 days and the untreated skin was used as a control. After 24 hours no signs of erythema nor oedema were observed. The only local observation were black test substance residues. Based on these data, the substance was not considered to be irritating to the skin (BASF 1972).

In vivo eye irritation (similar to OECD 405 with CAS 85186 -64 -7)

A pre-guideline study, similar to OECD 404 was performed. In this study 2 Vienna White rabbits were treated with ca. 50 mg into the conjunctival sac of the right eyelid. The exposure lasted for 24 hours, after which the test substance was not washed out. Observations were recorded after 1 hour, 24 hours and 8 days and a talcum treated eye was used as a control. After 1 hour mild redness and corneal opacity was observed, which were both reversible within 24 hours. Mild redness was also observed in the control eyes. In the substance treated eyes, black test substance residues were observed. Based on these data, the substance was not considered to be irritating to the eyes (BASF 1972).

Justification for classification or non-classification

Based on the available data classification and labelling for skin and eye irritation is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008