1-methylpiperidine

Endpoint summary

Description of key information

Skin: 
(1) Rabbit, shaved, undiluted test item, occlusive, 5 min, washing: corrosive, non-GLP, non-Guideline, Val. 2 (BASF XX/37, 1970).
(2) Rabbit, shaved, undiluted test item, semiocclusive, 3 min: corrosive, non-GLP, DOT Guideline, Val. 1 (PSL, 1994).
Eye: 
(1) Rabbit, undiluted test item: irritating, non-GLP, non-Guideline, Val. 2, (BASF XX/37, 1970).
The undiluted test item was corrosive to the skin of rabbits, caused irritating effects to the eye of rabbits and was reported to induce respiratory irritation.

Additional information

There are valid in vivo data available for the assessment of the acute oral, inhalative and dermal toxicity of the test item.

Skin irritation

In the key study, a non-GLP dermal irritation study according to an internal protocol (BASF XX/37, 1970), one male and one female Vienna White rabbit of 3.07 and 3.81 kg, respectively, were dermal exposed to 0.5 mL of the undiluted test item (analytical purity: no data) to an area of 6.25 cm² on the upper third of the back. Test sites were covered with an occlusive dressing for 1, 5 and 15 minutes. Readings were performed 24, and 48 hours as well as 5 and 8 days after removal of the test substance and washing of the skin. Animals were observed for 8 days. 

In animals treated for 1 min moderate edema was observed 24 and 48 hours as well as 5 days after treatment and parchment-like necrosis was detectable at the end of the observation period. After treatment for 5 and 15 min, leathery necrosis was observed after 24 hours, and hard necrosis after 48 hours.

The skin irritation study is acceptable (reliability 2), but does not satisfy the guideline requirements for a skin irritation study (OECD 404) in rabbits.

In the key study, the test item is corrosive to the skin based on hard, leathery necrosis observed after 5 min exposure at the reading time point of 48 hours in both animals.

In the supporting study, a non-GLP skin irritation study according to the DOT Guideline 173.136-137 (PSL 3020, 1994), 4 male and 2 female New Zealand White rabbits were dermal exposed to 0.5 mL of the undiluted test item (analytical purity: 99.6 %) to an area of 3 times 2.5 cm² of the shaved trunk. Test sites were covered with a semi-occlusive dressing for 3 minutes and 1 hour. Due to the presence of corrosion after 1 hour, the 4 hour treatment was finished at this time. Readings were performed 48 hours after removal of the test substance and washing of the skin. Animals were observed for 48 hours. 

Visible necrosis of the skin tissue was observed 48 hours after treatment at all test sites after 3 minutes exposure to the test material.

The skin irritation study is acceptable (reliability 1), and does satisfy the guideline requirements for an eye irritation study (OECD 404) in rabbits.

In the supporting study, the test item is corrosive to the skin based on necrosis observed after 3 min exposure at the reading time point of 48 hours in all animals.

Eye irritation

In a non-GLP eye irritation study performed similar to OECD guideline 405, 50 µL of the undiluted substance (analytical purity: 99.6 %) was instilled into one eye each of two New Zealand White rabbits (BASF, XX/37, 1974, Val. 2). The adjacent eyes were treated with saline and served as control. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. Readings were performed 10 min, 1, 24, 48 and 72 hours and 8 days after treatment. The test substance induced mean scores of 1.3 for conjunctivae redness, 0.0 for iris and cornea opacity, as well as 2.0 and 3.5 for chemosis during the relevant reading period (24, 48 and 72 hours). Conjunctivae score was fully reversible within 72 hours and chemosis score 8 days.

The eye irritation study is acceptable (reliability 2), but does not fully satisfy the guideline requirements for an eye irritation study (OECD 405) in rabbits (only 50 µL instilled, only 2 animals used, observation period only 8 days).

Due to corrosivity to the skin, the test substance can cause severe damage to eyes.

 

Respiratory irritation

There exists no standard test method for the assessment of respiratory irritation. There is some evidence from the described inhalation hazard test that the test substance vapour/aerosol causes strong mucosal irritating to the mucous membranes of rats (BASF XX/37, 1970; Val. 2).

Conclusion: The undiluted test item was corrosive to the skin of rabbits, is considered to cause severe damage to the eye in rabbits and was supposed to induce respiratory irritation.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data for skin and eye irritation/corrosion are reliable and suitable for the purpose of classification under Directive 67/548/EEC. As a result the substance is considered to be classified for skin irritation (C, R34) under Directive 67/548/EEC.

 

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

The available experimental test data for skin and eye irritation/corrosion are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. As a result the substance is considered to be classified for skin irritation (Cat 1B, H314, Causes severe skin burns and eye damage) under Regulation (EC) No.1272/2008, as amended for the 2nd time in Commission Regulation (EU) No. 286/2011.