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EC number: 700-714-9 | CAS number: 1254469-57-2
Endpoint summary
Administrative data
Description of key information
Skin irritation (Epiderm, BASF 2011): irritating
Eye irritation (Epiocular and BCOP, BASF 2011): irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation/corrosion:
The potential of Tinocat ES 96000 to cause dermal corrosion/irritation was assessed in a GLP-study according to OECD guidelines 431 and 439 by a single topical application of 25 μL bulk volume (about 11 mg) of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™).
For the corrosion test two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, respectively. The irritation test was performed with three EpiDerm™ tissue samples, which were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period.
Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The EpiDerm™ skin corrosivity/irritation test showed the following results:
The test substance is not able to reduce MTT directly.
Corrosion test:
The mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 98%, and it was 92% after an exposure period of 1 hour.
Irritation test:
The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 32%.
Corrosive potential of the test materials is predicted from the mean relative tissue viabilities obtained after 3 min treatment compared to the negative control tissues concurrently treated with highly de-ionized water. A chemical is considered as "corrosive", if the mean relative tissue viability after 3 min treatment with a test material is decreased below 50%. In addition, those materials with a viability of ≥ 50% after 3 min treatment are considered as "corrosive" if the mean relative tissue viability after 1 hour treatment with a test material is decreased below 15%.
Irritant potential of the test materials is predicted from the mean relative tissue viabilities compared to the negative control tissues concurrently treated with sterile PBS. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is less than or equal to 50%.
Based on the observed results and applying the evaluation criteria it was concluded, that Tinocat ES 96000 shows a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.
Eye irritation/corrosion:
BCOP
The potential of Tinocat ES 96000 to cause serious damage to the eyes was assessed by a single topical application of 750 μL of a 20% test-substance preparation to the epithelial surface of isolated bovine corneas (BCOP according to OECD 437 guideline and GLP).
Three corneas were treated with the test-substance preparation for an exposure period of 4 hours.
Corneal opacity was measured quantitatively as the amount of light transmission through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance relative to the control corneas.
The in vitro irritancy score of the the test substance was 14.5, the control value was 5.1 and the value of the positive control was 105.7. An in vitro irritancy score of greater than 55 is an indication for risk of serious damage to the eyes.
It was concluded, that Tinocat ES 96000 does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen.
EpiOcular
The potential of Tinocat ES 96000 to cause ocular irritation was assessed by a single topical application of 50 μL bulk volume (about 19 mg) of the test substance to a reconstructed three dimensional human cornea model (EpiOcular™) according to GLP.
Two EpiOcular™ tissue samples were incubated with the test substance for 90 minutes followed by a 18-hour post-incubation period.
Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The EpiOcular™ eye irritation test showed the following results:
The test substance is not able to reduce MTT directly.
The mean viability of the test-substance treated tissues was 3%.
The irritation potential of the test materials is predicted from the mean relative tissue viabilities compared to the negative control tissues concurrently treated with sterile water. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is less than or equal to 50%.
At present no prediction is performed if the mean relative tissue viability with a test material is > 50 ≤ 60% as the cut off value is currently being evaluated to lie in this range.
Based on the observed results and applying the evaluation criteria it was concluded, that Tinocat ES 96000 shows an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.
The test method does not yet allow for the evaluation of serious eye damage. The result does not exclude a serious eye irritation potential of the test substance. For final assignment of a risk phrase at present, results from another study would be needed.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
The Epiderm skin irritation test as well as the Epiocular test resulted in positive results for Tinocat ES 96000 with a viability of 32 % and 3 %, respectively. Therefore classification according to EU (67/548/EEC) - and CLP (1272/2008/EC) requirements is neccessary for this endpoint (EU: R36 and R38/ CLP: Cat. 2 eye and skin irritating).
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