Registration Dossier
Registration Dossier
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EC number: 700-182-8 | CAS number: 134652-60-1
Endpoint summary
Administrative data
Description of key information
Summary of irritation / corrosion
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)
Additional information
Skin irritation
Two studies were evaluated on this endpoint (an in vitro study and an in vivo study).
The results of the in vitro study, which used EPISKINTM reconstituted human epidermis (EPISKIN Standard Model™), showed TIS-M to be not irritating.
In the in vivo study, 3 female rabbits each received a single four hour application of the test sample to the shorn flank. The animals were assessed for any signs of irritation for up to 3 days after application. Dermal exposure to TIS-M caused slight erythema in 2 animals (reversible within 24 and 48 hours, respectively). Based on these results, TIS-M is not classified as a skin irritant.
Eye irritation
Two studies were evaluated on this endpoint (an in vitro study and an in vivo study).
The results of the in vitro study using bovine corneas showed TIS-M to be not irritating.
In the in vivo study, application of the test sample into the conjunctival sac of three rabbits caused conjunctival redness (score 1) and conjunctival discharge (score 1) after 1 hour. After 24 hours, conjunctival redness (score 1) was observed in just one animal. At 48 hours and 72 hours after treatment, no clinical signs were observed. Based on these results, TIS-M is not classified as an eye irritant.
Respiratory irritation
Respiratory irritation was not assessed; however no effects of this kind on any animals were noted in any associated studies.
The following information is taken into account for any hazard / risk assessment:
Value used for CSA:
- Skin irritation / corrosion: not irritating
- Eye irritation: not irritating
- Respiratory irritation: not irritating
Justification for classification or non-classification
The above studies have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP an in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for irritant effects is therefore required.
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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