Isopropylamine

Endpoint summary

Description of key information

The submission substance was corrosive to skin and eyes and irritating to the respiratory tract.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin irritation

 Undiluted isopropylamine was corrosive in a GLP study conducted in accordance with International Maritime Organization (I.M.O.) criteria (Siglin, 1989). Three New Zealand White rabbits exposed (occlusive) to 0.5 mL test solution for three minutes had necrosis and slight edema beginning at three minutes and progressing to eschar at 24 hours post-dose; eschar persisted through the remainder of the 7-day study. Two Vienna White rabbits were exposed to isopropylamine for 1, 5 or 15 minutes under occlusive cover (BASF, 1960). The application of the test substance for 1, 5 or 15 minutes caused brown-blackish hard necrosis. The effects were considered as full thickness necrosis. At the end of the 3 week observation period scar formation was observed.

 

Eye irritation

Isopropylamine was corrosive to the eye in a study using standard methods. One rabbit (strain not specified) was dosed with 0.1 mL of undiluted test material without rinsing and evaluated after 24 hours. The response included moderate to severe conjunctival irritation (redness, chemosis, discharge, and necrosis) and corneal opacity, stippling, and ulceration. The iris could not be evaluated (Blaszcak and Auletta, 1985).

One drop (about 0.05 ml) isopropylamine was instilled into the eye of each of three Vienna White rabbits (BASF, 1960). There was severe corrosion of the mucous membranes and the cornea predominantly expressed by erythema, chemosis and corneal opacity. At the end of the observation period of 19 days the mucous membranes and the cornea were completely destroyed and caused the loss of the eye.

 

0.5 ml of a 10% solution of isopropylamine was instilled in the eye of up to 5 albino rabbits (Smyth, Carpenter and Weil, 1951; Cavender, Bingham, Cohrssen, and Powell (editors), 2000; Carpenter and Smyth, 1946). The substance caused an irritation score of 10 on a 10-grade scale (method described in Carpenter and Smyth, 1946) and was considered corrosive.

 

Respiratory tract irritation

In a study conducted according to according to EPA OTS 798.1150 (see section Acute inhalation toxicity), groups of Sprague-Dawley rats (5/sex/concentration) were exposed by whole body vapor inhalation for four hours to concentrations of 2.3, 2.8, 5.1, or 6.5 mg/L (measured) (Hoffman and Newton, 1990). Clinical signs of respiratory tract irritation included labored breathing and nasal discharge, which persisted the first week post-exposure, but moist and dry rales were observed in most of the survivors throughout 14 days. At gross necropsy the nasal turbinates and lungs were reddened and swollen with lung emphysema present in a few animals.

The study by Gagnaire et al. (1989/1993), see section 7.9.4, supports sensory irritation of the respiratory tract.

Justification for classification or non-classification

Based on the experimental findings and according to the requirements of Regulation (EC) No 1272/2008 it is suggested to classify isopropylamine as corrosive to skin (Cat. 1A) and as causing serious eye damage (Cat. 1). Additionally, classification for toxicity after single exposure (May cause respiratory irritation - STOT SE 3) is proposed.