Registration Dossier

Administrative data

Description of key information

Skin irritation
Rabbit, abraded skin, open, 0.5 mL for 4 h: not irritant (Biodynamics 1987)
Eye irritation
Rabbit, 0.5 mL, not rinsed: minimal corneal injury, quickly healing (Smyth et al. 1969, Union Carbide Corp., 1961)
Analogous substance: Isopropyl acetate, CAS 108-21-4
Human, occupational survey: slow healing (3-10 d) of chemical burns after mechanical removal of the affected epithelium cells (McLaughlin 1946)
Respiratory tract
Rat, 4 h, >= 33.36 mg/L: pulmonary hemorrhage (Smyth et al. 1969)

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

The assessment of the skin and eye irritation potential of propyl acetate is problematic due to the limited documentation or the incompatible scoring system of the available studies. An eye irritation potential is assessed due to human data of the analogous substance isopropyl acetate (CAS No. 108-21-4). Therefore, propyl acetate is considered as not skin irritant and not respiratory irritant, but as an eye irritant (R36 according to EU directive 67/548/EEC annex I, corresponding to GHS eye irritation Cat. 2).

skin irritation/corrosion

Application of 0.5 ml undiluted n-propyl acetate to the uncovered clipped, abraded skin of male and female rabbits for 4 hours produced minor irritation with slight erythema and no edema 72 hours after application (Biodynamics Inc., 1987). Application of 0.01 ml to the skin of 5 rabbits under non-occluded conditions for a 24-hour interval resulted in no irritation, described as Grade

1 on a Draize scale of 10 when 0.01 ml were applied to the skin (Union Carbide Corp., 1961, reliability score 3 due to the low application volume). In an acute dermal toxicity study, however, application of a large volume (20 mL) of n-propyl acetate under occlusion for 24 hours to the skin of rabbits resulted in erythema and necrosis of the skin (Union Carbide, 1961; Smyth et al., 1969; reliablility score 3 due to the large application volume).

eye irritation

Instillation of a flooding volume (0.5 ml) of undiluted n-propyl acetate into the rabbit eye resulted in diffuse corneal injury that healed quickly; eye injury was described as Grade 2 on a Draize scale of 0 to 10 (Smyth et al., 1969, Union Carbide Corp., 1961). These results indicate that n-propyl acetate can cause minor corneal injury.

Analogous substance: Isopropyl acetate, CAS 108-21-4

In an occupational survey based on almost 500 cases of chemical burns of the cornea, two cases of burns caused by isopropyl acetate were reported to be slow healing (3 -10 d) after the mechanical removal of the affected epithelium cells, the so called "denuding technique"; McLaughlin 1946). This treatment was done to stop the oftenly observed progression of epithelian cell destruction. Even if this technique sounds inconvenient, it represents a probable way to reduce eye irritation or irreversible damage on eyes.

respiratory tract irritation

Studies that specifically evaluated respiratory tract irritation are not available. However, acute inhalation toxicity studies in rats have been conducted with propyl acetate vapour at concentrations up to 16,000 ppm (66.72 mg/L). Necropsy of animals dying during acute exposure to 16,000 and 8000 ppm revealed pulmonary hemorrhage. Necropsy of surviving animals after a 14-day observation interval revealed evidence of earlier lung damage (Smyth et al., 1969). Results of acute inhalation toxicity studies suggest that propyl acetate as a vapour or aerosol may cause respiratory irritation only in high concentrations which were not relevant for classification.

Justification for classification or non-classification

Skin

Due to the very mild effects seen on abraded rabbit skin, propyl acetate is considered as not irritant to the skin.

Eye

Propyl acetate caused diffuse corneal injury of the rabbit eye, which is caused by 0.5 mL undiluted test substance. Additionally, for the analogous substance isopropyl acetate two clinical cases were described with slowly healing chemical burns of the cornea. Therefore, propyl acetate is classified as skin irritant (R36 according to EU directive 67/548/EEC annex I, corresponding to GHS eye irritation Cat. 2).

Respiratory tract

Results of acute inhalation toxicity studies suggest that propyl acetate as a vapour or aerosol may cause respiratory irritation only in high concentrations which were not relevant for classification (>= 33.36 mg/L). Therefore, propyl acetate is not considered as irritant to the respiratory tract.