Propanamide, 3-amino-2,2-dimethyl-

Endpoint summary

Description of key information

- skin:
(1) Rabbit, semiocclusive, clipped, 4 hours: not irritating (OECD guideline 404)
(2) In vitro, reconstructed three dimensional human epidermis model (EpiDermTM), 1 hour: not corrosive (OECD guideline 431)
- eye:
Rabbit (no rinsing): risk of serious damage to eyes (OECD guideline 405)

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:

adverse effect observed (irritating)

Additional information

Skin irritation:

 

In a skin irritation study conducted by ARC (2005) according to the protocol of OECD 404 (2002), undiluted 3 -amino-2,2-dimethyl-propionamide was applied to the clipped skin of 3 New Zealand White rabbits under a semiocclusive dressing for an exposure period of 4 hours. After 4 hours an erythema score of 1 (very slight reddening) was determined 1 hour after removal of the test substance in one animal. No other signs of irritation (score 0) were noted after 24, 48 and 72 hours. No other signs of intoxication were observed. The substance was assessed to be not irritating to the skin.

 

The potential of 3-amino-2,2-dimethyl-propanamideto cause dermal corrosion was assessed by a single topical application of 25 µL bulk volume (about 10 mg) of the test substance to a reconstructed three dimensional human epidermis model (EpiDermTM) (BASF AG, 2005) in a study performed according to OECD guideline 431 and under GLP. Two EpiDermTM tissue samples were incubated with the test substance for 3 minutes and 1 hour, each. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure 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 suitable endpoint. The formazan production of the test substance treated epidermal tissues was compared to that of negative control tissues. The quotient of both values indicates the relative tissue viability. The test substance was able to directly reduce MTT. However, this ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of control tissues inactivated by freezing. Viability of the test substance treated tissues determined after an exposure period of 3 minutes was 96%. Viability of the test substance treated tissues determined after an exposure period of 1 hour was 67%. It was concluded,that 3-amino-2,2-dimethyl-propanamide does not show a corrosive potentialin the EpiDermTM skin corrosivity test under the test conditions chosen.

Eye irritation:

 

In an eye irritation study performed by ARC 2005 according to OECD guideline 405 and the Directive 2004/73/EC, method B.5., the undiluted substance was applied to the eye of one New Zealand White rabbit. As the test substance was found to cause a risk of serious damage to eyes, the test substance was not administered to further rabbits.The test substance was not washed out and induced mean scores of 0.7 for cornea opacity, 3.0 for conjunctiva redness, 0.0 for iris, and 1.0 for chemosis during the relevant reading period (24 -72 h). On day 7, the animal showed a pronounced conjunctiva redness score of 3, later on decreasing to slight redness (score 1) 21 days after administration. Additionally, for chemosis, a slight swelling (score 1) was observed until day 21. Due to the failure of reversibility within 21 days, 3-Amino-2,2-dimethyl-propanamide was considered to induce serious damage to eyes.

 

Respiratory tract irritation:

 

There are no data available concerning the irritating potential to the respiratory system.

Effects on eye irritation: corrosive

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on the results of the available eye irritation study, 3-amino-2,2-dimethyl-propionamide does have to be classified according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 with Xi; R41 (Risk of serious damage to eyes) and H318; Cat. 1 (serious eye damage/eye irritation), respectively.

 

Based on the results of the skin irritation studies, the substance does not need to be classified according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.