1-Piperazineacetamide, N-(2,6-dimethylphenyl)-

Endpoint summary

Description of key information

Skin irritation/corrosion: Test method according to OECD Guideline 430. GLP study. The test substance does not lead to skin corrosion/severe irritation. 
Eye irritation: Test method according to OECD Guideline 438. GLP study. The test item can cause eye damage.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion: Key study: The in vitro skin corrosion: transcutaneous electrical resistance test (TER) was performed according to OECD Guideline 430 and EU Method B.40 (GLP study). Skin discs used in the experiment were obtained from two 30 -day-old animals. The test item was uniformly applied to the epidermal surface of the skin disc placed inside a tube. Concurrent positive (36% hydrochloric acid) and negative (distilled water) controls were used. Three skin discs obtained from each animal were used for the test item and each control item. The test item and the control items were evenly applied to the discs for 24 hours and kept at 21-22°C. Then, they were removed by washing with a jet of tap water. The skin discs were subjected to a gross examination in order to reveal possible damage. The dye binding procedure was necessary in this case since all TER values for the test item were lower than 5 kΩ, and the skin discs did not exhibit any visible pathological changes. The mean treated disc dye contents were equal to 24.64 μg/disc (animal no. 1) and 21.81 μg/disc (animal no. 2). On the grounds of the results, it may be stated that the test substance does not lead to skin corrosion/severe irritation, as the mean disc Sulforhodamine B dye content of the treated skin discs was lower than the mean disc dye content of the concurrent 36% HCl positive control.

Eye irritation: Key study: The isolated chicken eye test (in vitro) was performed according to OECD Guideline 438 and EU Method B.48 (GLP study). Toxic effects to the cornea were measured by a qualitative assessment of damage to epithelium based on application of fluorescein to the eye (fluorescein retention), a qualitative assessment of opacity, a quantitative measurement of increased thickness (swelling), and macroscopic and histopathological examinations of morphological damage to the surface. The study was conducted in two runs. At all observation time points, corneal opacity, corneal swelling, and morphological changes of the corneal surface were recorded. Fluorescein retention was determined once, i.e. 30 minutes after the end of the exposure. Following the final evaluation of the treated eyeballs, i.e. 240 minutes after the application of the test item and the control items, the eyeballs were fixed in a 4% solution of formaldehyde in order to allow histopathological examinations to be conducted. The test item caused eye damage. For the eyeballs treated with the test item, the mean fluorescein retention scores were 3.0 (ICE class IV) in both first and second runs. The mean corneal opacity scores ranged from 2.3 (ICE class III) to 3.0 (ICE class IV) in both rounds. The mean corneal swelling values ranged from 28.47 (ICE class IV) to 64.95 (ICE class IV) in the first run, and from 29.33 (ICE class IV) to 54.28 (ICE class IV) in the second run. Gross examinations of the eyeballs treated with the test item revealed roughening of the corneal surface in both first and second run. Histopathological examinations of the corneas showed dissection of the anterior corneal epithelium and defects on the anterior corneal epithelium in both runs in addition to necrosis of the anterior corneal epithelium in the first run and cell vacuolation of the anterior corneal epithelium in the second run. According to the UN GHS classification criteria, the test item can be classified into Category 1, since the ICE class combination of the 3 endpoints was 3xIV (the first run) and 3xIV (the second run).

Justification for selection of skin irritation / corrosion endpoint:
Only one study available.

Justification for selection of eye irritation endpoint:
Only one study available.

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on the available information, the substance is classified as Eye Damage Category 1, H318 according to CLP Regulation (EC) no. 1272/2008.