Registration Dossier
Registration Dossier
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EC number: 947-818-2 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Two in vitro irritation studies were conducted on the test article. The results of the studies are:
EpiDerm human reconstructed epidermus (OECD 439): Not irritating
Bovine Corneal Opacity and Permeability (OECD 437): Not irritating
The dermal irritation potential of MTDID 44430 was evaluated in EpiDerm per OECD 439. Human reconstructured epidermal tissues (n=3) were exposed to 30 uL of the test article (neat) for a 60 minute exposure period. Following the exposure period, the tissues were washed with DPBS and incubated for 42 hours. Following incubation, the tissue viability was measured via MTT assay and compared to the negative control. After a 60 -minute exposure period and a 42 -hour post-exposure period, the mean viability of the test article was 95% (93, 98, and 94%). MTDID 44430 is therefore considered to be not irritating to the skin.
The ocular irritation potential of the MTDID 44430 was evaluated in the Bovine Corneal Opacity and Permeability (BCOP) assay. The study was conducted according to OECD 437 in compliance with OECD GLP regulations. Corneas (n=3) were exposed to 750 uL of the test article, positive control (ethanol) or negative control (physiological saline) for 10 minutes. The corneas were then washed with MEM and phenol red and cMEM and incubated in fresh medium for 120 minutes. Following incubation, corneal opacity measurements were taken and permeability was evaluated with sodium fluorescein. The positive and negative controls performed as expected, indicating that the test system is valid. The corneas treated with MTDID 44430 showed opacity values ranging from -1.5 to -0.5 and permeability values ranging from -0.005 to 0.007. The corneas were clear after the 10 minute exposure to the test article. No pH effect of the test article was observed on the rinsing medium The in vitro irritancy scores (IVIS) ranged from -1.6 to -0.4, resulting in a mean IVIS of -1.2. Based on the results of the study (IVIS = -1.2), MTDID 44430 is not an ocular irritant.
Key value for chemical safety assessment
Additional information
Justification for classification or non-classification
Based on the results of the studies, the test article is not classified for eye or skin irritation.
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