Reaction product of propargyl chloride and sodium bisulfite

Endpoint summary

Description of key information

skin irritation/corrosion: not irritant

eye irritation: 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

Skin

The potential of the test item to induce skin irritation was accessed in a GLP-conform in vitro study according OECD TG 439. The Skin irritation test was performed using the EpiDerm^TM model, which consists of normal, human-derived epidermal keratinocytes. 30 µL of the undiluted test item was placed on the reconstructed three dimensional human epidermis model and incubated for 25 min at room temperature and 35 min at 37°C, followed by a 42 -hour post-incubation period. As negative control (NC) sterile PBS was used and a dilution of 5% SDS in water was used as positive control (PC). The viability of the cells was measured using a colorimetic test (MTT-assay). The formazan production of the test-substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.

The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 97.5%. The PC-treated skin tissues showed a cell viability of 2.8%. Based on the observed results it was concluded, that the test item does not show a skin irritation potential in the EpiDerm™ in vitro skin irritation and corrosion test under the test conditions chosen (BASF SE,68V0178/16A158; 2017).

The potential of the test item to induce skin corrosion was accessed in a GLP-conform in vitro study according OECD TG 431. The test was performed using the EpiDerm^TM model, which consists of normal, human-derived epidermal keratinocytes. 50 µL of the undiluted test item was placed on the reconstructed three dimensional human epidermis model and incubated for 3 min or 1 hour at 37°C. As negative control (NC) de-ionized water was used and 8 N potassium hydroxide was used as positive control (PC). Two tissues were used per exposure time and test group. The viability of the cells was measured using a colorimetic test (MTT-assay). The formazan production of the test-substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.

The test substance is not able to reduce MTT directly. Viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 97.0%. Viability of the test-substance treated tissues determined after an exposure period of 1 hour was 70.9%. Based on the observed results the test item does not show a corrosion potential in the EpiDerm^TM in vitro skin corrosion test under the test conditions chosen (BASF SE 61V0178/16A145; 2016).

The lack of a skin irritating/corrosive potential is also supported by an older in vivo study in rabbits (BASF SE VIII/82; 1958).

Eye

A study according OECD TG 431 was conducted to assess the eye irritating potential of the test item. A volume of 50 µL of the undiluted test item was applied topically to a reconstructed three dimensional human cornea model (EpiOcular^TM). Two tissues were incubated with the test item for 30 minutes followed by a 2-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 test-substance treated epidermal tissues is compared to that of negative control tissues. The ratio of the values indicates the relative tissue viability.

The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues was 83.8%. Based on the observed results for the EpiOcular Test it was concluded, that the test item does not show an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen (BASF SE 71V0178/16A146; 2016).

The lack of an eye irritation potential is also supported by an older in vivo study in rabbits (BASF SE VIII/82; 1958).

 

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No 1272/2008. Based on these information the test item is not considered to be classified for skin and eye irritation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.