Registration Dossier
Registration Dossier
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EC number: 954-598-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin Irritation/Corrosion
Non irritant
Eye Irritation/Corrosion
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:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation/Corrosion
One test is available on similar substance 1.
The test item was assayed for the in vitro skin irritation in human epidermal model EpiDermTM. The test was performed according to the OECD Test Guideline No.439.
After pre-incubation of tissues, 25 mg of the test substance was placed directly atop to the previously moistened tissue and it was spread on the entire tissue surface. Length of exposition was 60 minutes. Three tissues were used for the test substance and every control. Two tissues more were used as colorant control to correction of possible colour interference, which undergo the entire testing procedure excepting of incubation with MTT medium.
After removal of the test substance, tissues were post-incubated for approximately 42 hours due to leave of damage reparation. Three hours incubation with MTT and two hours extraction period with shaking followed then. Optical density (OD570) of isopropyl alcohol extracts was measured on a spectrophotometer. Relative cell viability was calculated for each tissue as % of the mean viability of the negative control tissues.
Under the above-described experimental design average viability of treated tissues was 75.7 % (75.0 % after correction).
Eye Irritation/Corrosion
One test is available on similar substance 1.
The test substance was tested for the evaluation of the potential ocular corrosivity or severe irritancy as measured by its ability to induce opacity and increased permeability in an isolated bovine cornea. The test was performed according to the OECD Test Guideline No. 437.
The test was performed using nine isolated bovine corneas. The testing was performed on three groups of corneas: test substance treatment group, positive control group and negative control group. Three corneas per group were used.
Closed-chamber method was used, because the test substance was applicable by micropipette. The opacity and permeability of each cornea were measured. The In Vitro Irritancy Score (IVIS) was calculated from the values of opacity and permeability.
The In Vitro Irritancy Score (IVIS) for the test substance was 32.68 but this result could be affected by higher opacity values (corneas were coloured by the test substance:red-brown colour).
Justification for classification or non-classification
Skin Irritation
The ECHA Guidance on the application of the CLP Criteria set out that normally, therecommendations for classification according to GHS criteria based on the results of anin vitro test are mentioned in the corresponding OECD test guideline. According to the OECD Guideline 439 the cut-off values for the prediction of irritation are:
- The test chemical is considered to be irritant to skin in accordance with UN GHS Category 2 if the tissue viability after exposure and post-treatment incubation is less than or equal (≤) to 50 %.
- The test chemical may be considered as non-irritant to skin in accordance with UN GHS No Category if the tissue viability after exposure and post-treatment incubation is more than (>) 50 %.
The test item showed a value of the relative absorbance (75 %) above the threshold for irritation potential set out in the OECD guideline, therefore the substance is considered as NOT IRRITANT
Eye Irritation
The ECHA Guidance on the application of the CLP Criteria set out that a substance can be considered as causing serious eye damage (Category 1) based on positive results in the BCOP test, and a negative results from the BCOP test methods can be used for classification purposes.
According to the OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants),the IVIS cut-off values for identifying test chemicals as inducing serious eye damage (UN GHS Category 1) and test chemicals not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are:
- IVIS ≤ 3 – No Classification (UN GHS)
- IVIS > 3; ≤ 55 – No prediction can be made on the non classification
- IVIS > 55 – Category 1 (UN GHS)
The test item showed a value of in vitro irritancy score (IVIS ) of 32.68, therefore in the range of no prediction ( 3 > IVIS ≤ 55 ). Using a conservative approach, the test substance has been classified as Irritant to eyes Category 2, according to the CLP Regulation n. 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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