Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Irritation:
- skin: corrosive
- eye: corrosive

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 (irritating)

Additional information

Skin irritation:

In a primary skin irritation study with undiluted dipropylamine, exposure of 1 min caused after 24 h full thickness necrosis and was not reversible within the 8 day observation period (BASF AG 1969; reliability score 2). In a newer studies 3 min and already 1minapplication dipropylamine produced dermal corrosion at all sites exposed to the test article (Hoechst, 1989 and 1993; Val. 2). The dermal response was initially characterized by necrosis and progressed to eschar after 1 h in 2/3 rabbits and 3/3 rabbits 24 h postdose. The eschar persisted throughout the remainder of the seven day study. Corrosive effects of undiluted test substance to skin were found in three other studies where only limited data is provided (Union Carbide, 1957; Val. 2; Eastman Kodak, 1955 / Dow Chemical, 1973; Val. 4).

 

Eye irritation:

In a primary eye irritation study in rabbits, 50 µL of the test substance caused severe corrosion predominantly expressed by corneal opacity. Due to these severe and irreversible effects the test was terminated after 72 h. (BASF AG 1969;Val. 2). In a newer study the eye irritation potential of dipropylamine was evaluated in 4 rabbits administered 0.1 ml undiluted doses into right eyes, the left eyes serving as negative control. The treated eyes remained unrinsed and were evaluated for signs of irritation up to 7 days post-instillation. Responses were profound and included corneal opacity, stippling and ulceration to prevent grading of iritis in 3 rabbits at 24th hour evaluation. Severe conjunctival irritation in all 4 animals was characterized by redness, chemosis, discharge, and/or ulceration. Humane intervention terminated study for the 3 worst effected animals after 24th hour evaluation. Upon Day 7 examination, the remaining rabbit continued to exhibit corneal opacity, stippling, and pannous with moderate-severe conjunctival irritation and iridic changes (Hoechst, 1989; Val. 2). Three further studies confirmed these severe corrosive effects (Union Carbide, 1957; Val. 2; Eastman Kodak, 1955 / Dow Chemical, 1973; Val. 4).


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

EU classification according to Annex I of Directive 67/548/EEC: C; R35

Categories Display