Registration Dossier
Registration Dossier
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EC number: 800-003-4 | CAS number: 1415316-96-9
Endpoint summary
Administrative data
Description of key information
Skin irritation in vitro: Not irritant (OECD 439), BASF 2017
Eye irritation in vitro: Not irritant (BCOP, EpiOcular), BASF 2017
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 study available
Additional information
To assess the irritation potential of the registered substance, an undiluted, i.e., water free batch was prepared for in vitro testing.
The potential of the test substance to cause dermal irritation was assessed by a single topical application of 30 μL of the undiluted test substance to a reconstructed threedimensional human epidermis model (EpiDerm™). The test substance was removed after 1h, and incubation continued for another 42h. Tissue destruction was determined by measuring MTT reduction. The final mean viability of the three treated tissues was 69.7%. A substance is considered a skin irritant, if viability is reduced below 45% compared to the negative control. Consequently, it was concluded that the registered substance does not cause skin irritation. A further study to assess potential corrosive properties is not needed.
Eye irritation was evaluated by a combination of two in vitro studies, a BCOP according to OECD 437 and an EpiOcular assay according to OECD 492 (BASF 2017).
The potential of the test substance to cause ocular irritation or serious damage to the eyes was assessed by a single topical application of 750 μL undiluted test substance to the epithelial surface of isolated bovine corneas. Three corneas were treated with the test substance for 10 minutes followed by a 2-hour postincubation period. In addition to the test substance, a negative control (NC; deionized water) and two positive
controls (PC1 / PC2; 100% ethanol / 100% dimethylformamide) were applied to three corneas each. The IVIS score for Efka FA 4671 was 0. All controls were valid.
The potential of the test substance to cause ocular irritation was assessed by a single topical application of 50 μL undiluted test substance to a reconstructed three-dimensional, human cornea model (EpiOcular™).
Two test runs were performed. Two EpiOcular™ tissues per test run were incubated with the test substance for 30 minutes followed by a 2-hour post-incubation period. In the 1st test run the final mean viability of the tissues treated with the test substance was 62.3%. Due to the borderline result, another test run was performed to verify the result. In the 2nd test run the final mean viability of the tissues treated with the test substance was 95.4%.
Justification for classification or non-classification
Since the substance was identified as a non-irritant in all in vitro assays for skin and eye irritation, no classification according to EU GHS, Regulation (EC) 1272/2008 is 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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