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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation (OECDTG439): not irritant


Skin irritation/corrosion (OECDTG404): not irritant


Eye irritation (OECDTG492): not 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:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Executive summaries of the studies performed with the source substance:


 


In a test according to OECD 439 the substance was tested for possible skin irritation through topical application for 15 minutes on a human three dimensional epidermal model (EPISKIN Small model (EPISKIN-SM).
Skin tissue was moistened with 5 µL of Milli-Q water and at least 10 mg of the test item was applied directly on top of the skin tissue for 15 ± 0.5 minutes. After a 42 ± 1 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.


The test item did interact with MTT. In addition to the normal procedure, three killed tissues treated with test item and three killed untreated tissues were used for the cytotoxicity evaluation with MTT. The non-specific reduction of MTT by the test item was 1.6% of the negative control tissues. The net OD of the treated killed tissues was subtracted from the ODs of the test item treated viable tissues.


Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 109%. Since the mean relative tissue viability for the test item was above 50% after 15 ± 0.5 minutes treatment the test item is considered to be non-irritant.


The positive control had a mean cell viability of 4.3% after 15 ± 0.5 minutes exposure. The absolute mean OD570  of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was ≤ 4.6%, indicating that the test system functioned properly.


In conclusion,the substance is non-irritant in the in vitro skin irritation test under the experimental conditions described.


 


In a test according to OECD 492, the substance (50.9 to 54.2 mg) was applied directly on top of the tissue for 6 hours ± 15 minutes.


After exposure the cornea epithelial construct was thoroughly rinsed to remove the test item and transferred to fresh medium for an immersion incubation. Afterwards, the tissues were transferred to fresh medium and incubated for 18 hours at standard culture conditions, prior to determination of the cytotoxic (irritancy) effect.


The positive control had a mean cell viability of 19% after 6 hours ± 15 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The difference between the percentage of viability of two tissues treated identically was less than 6%, indicating that the test system functioned properly.


The test item did interact with 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT). In addition to the normal procedure, two freeze-killed tissues treated with test item and one freeze-killed negative control treated tissue were used for the cytotoxicity evaluation with MTT. The non-specific reduction of MTT by the test item was 0.003% of the negative control tissues. The ODs of the test item treated viable tissues was corrected using he OD of the freeze-killed tissues.


Eye hazard potential is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 6 hours ± 15 minutes treatment with the test item compared to the negative control tissues was 78%. Since the mean relative tissue viability for the test item was above 60% after 6 hours ± 15 minutes treatment the test item is considered to be non-irritant.


In conclusion, the substance is non-irritant in the EpiOcular™ test under the experimental conditions described in this report.

Justification for classification or non-classification

Based on the available study results, the substance does not have to be classified and has no obligatory labelling requirement for skin and eye irritation according to Regulation (EC) No 1272/2008 and its amendments.