Registration Dossier
Registration Dossier
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EC number: 946-245-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin irritation: the substance does not cause skin irritation based on OECD TG 439
Eye irritation: not irritant based on OECD TG 438
The substance is not a skin or eye irritant and therefore it is not likely to be a respiratory irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
Skin irritating properties of the substance were tested in an in vitro skin irritation test using the EpiDerm(TM) reconstructed skin membranes (OECD TG 439) and in compliance with GLP. Skin tissue was exposed to 30 μL of test material for 60 min, washed, incubated in medium for 42 hours and then examined for viability by the MTT assay. Phosphate-buffered saline and 5% sodium dodecyl sulphate were used as positive and negative control, respectively. Mean tissue viability of the positive control was 4%. Tissue viability following exposure to the substance was 87± 8% (mean ± SD) compared to the negative control. As this value was above the limit value of 50%, the substance was considered to be non-irritating to human skin.
Eye irritation
The eye irritating properties of the substance were tested in vitro, in an Isolated Chicken Eye (ICE) test according to OECD TG 438 and in compliance with GLP. The test included a negative control (saline) and a positive control (5% benzalkonium chloride). The isolated chicken eyes were treated with of 30 μL of the substance for 10 seconds and then rinsed with 20 mL saline. Corneal swelling, corneal opacity and fluorescein retention were measured to disclose possible adverse effects. The substance caused no swelling of the cornea (0%), slight corneal opacity (score 1 out of max. 4) and slight fluorescein retention (score 1 out of max.3). The corresponding irritation categories were I, II and II, respectively. The irritation index (calculated as maximum corneal swelling + maximum mean opacity (x 20) + mean fluorescein score (x 20)) was 40 (out of max. 200). The positive control produced moderate corneal swelling (29%), severe opacity (score 3.0) and severe fluorescein retention (score 3.0). The calculated irritation index was 149. Based on the results of this in vitro study, the substance is considered not irritating to the eye.
Respiratory irritation:
For respiratory irritation mostly human data are used for the assessment because no suitable in vitro or in vivo tests are available that can identify respiratory irritation (REACH guidance R.7.2.3). There are no human data such as indicated in R7.2.3 of the ECHA guidance that indicate respiratory reactions of the substance e.g. from consumer experience or occupational exposure. In addition, the substance is not corrosive or severely irritating which further minimizes the respiratory irritation hazard (REACH guidance: 7.2.1.2).
Justification for classification or non-classification
Based on the negative results of the available studies, classification of the substance for skin, eye or respiratory irritation is not warranted according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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