2-Propenoic acid, reaction products with pentaerythritol

Endpoint summary

Description of key information

The substance is irritating to skin and highly irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin

A study was performed to assess the irritation potential of PETIA to rabbit skin according to a method equivalent or similar to OECD Guideline 404. 0.5 mL was applied to the intact and abraded skin under gauze pads and was covered with 'Elastoplast' elastic adhesive dressing backed with 'Sleek' waterproof strapping for 24 h. After 24 h of exposure, PETIA was removed and the animals were scored for irritation reactions at 24 and 72 h post-application. Very slight to well-defined erythema with very slight to moderate oedema was observed at 24 h post-application at intact and abraded sites in all animals. At 72 h reading, reactions had gradually ameliorated in four animals when very slight to well-defined erythema with or without very slight to slight oedema were seen. Well-defined erythema with slight to moderate oedema was seen in two animals. A necrotic patch or edge was seen at two intact and one abraded site. In conclusion, under the conditions of the study, the primary skin irritation score of the substance was calculated to be 3.29 (Parcell, 1997).

A study was performed to assess the irritation potential of PETIA to rabbit skin according to method described in the Code of Federal Regulations, Title 16, Section 1500.41. 0.5 mL of the test material was applied to the intact and abraded skin under gauze pads and wrapped with an impervious material such as a rubberized cloth for 24 h. After 24 h of exposure, the substance was removedand the animals were scored for irritation reactions at 24 and 72 h post-application. Very slight to well-defined erythema with very slight to severe oedema was observed in all animals at 24 and 72 h post-application. Blanching of the skin was observed in one intact and two abraded sites and scab formation was present in one intact site. Under the conditions of the study, the primary skin irritation index of the test substance was calculated to be 4.3 (Kynoch and Ligett, 1977).

A study was performed to assess the irritation potential of SN-1716 rabbit skin according to a method equivalent or similar to OECD Guideline 404 (Acute Dermal Irritation / Corrosion). 0.5 mLwas applied to the intact and abraded skin under gauze pads and wrapped with impervious plastic sheeting for 24 h. After 24 h of exposure, the substance was removed and the animals were scored for skin irritationreactions at 24 and 72 h post-application. Very slight to well-defined erythema with very slight to severe oedema was observed in animals at 24 and 72 h post-application. Second degree chemical burns (score of 4) were observed at abraded site at 24 h post-application in four animals. Third degree chemical burn (score of 4) was observed at intact site at 72 h post-application in one animal. In conclusion, under the conditions of the study, the primary irritation score of the test substance was calculated to be 5.0 (Trzyna and Paa, 1976).

A study was performed to assess the irritation potential of SN-1777 to rabbit skin according to a method equivalent or similar to OECD Guideline 404. 0.5 mL was applied to the intact and abraded skin under gauze pads and wrapped with impervious plastic sheeting for 24 h. After 24 h of exposure, the substance was removed and the animals were observed for skin reactions at 24 and 72 h post-application. Very slight to well-defined erythema with very slight to well-defined oedema was observed in animals at 24 and 72 h post-application. Second degree chemical burns (score of 4) was observed at abraded site of application in two animals. Under the conditions of the study, the primary skin irritation score of the substance was calculated to be 2.5 (Baker, 1976).

Eye

A study was conducted to evaluate the eye irritation potential of C-171 in rabbit eyes. The study performed was similar to OECD Guideline 405. 0.1 mL of the substance was instilled into the right eye of nine rabbits; the left eye served as an untreated control. One group of six rabbits received no further treatment. In the second group, three rabbits eyes were rinsed 20 s post-instillation for 60 s. Irritation was scored by the Draize scoring system at 24, 48 and 72 h and 4, 7, 9, 11 and 14 d post-instillation. The substance caused extensive eye damage. Response was so severe that many parameters in animals with non-rinsed eyes could not be evaluated: these animals were sacrificed at Day 7 for humane reasons. Animals with rinsed eyes exhibited positive scores for all parameters (conjunctival redness, chemosis, necrosis and ulceration, corneal opacity and ulceration, and iridial damage). All three animals exhibited pannus and continued to exhibit signs of irritation at termination of the observation period (Day 14). In conclusion, under the conditions of the study, the test substance was found to be highly irritating to the rabbit eye (Auletta, 1980b).

A study was performed to assess the eye irritation potential of SN-1716 to rabbits according to a method equivalent or similar to OECD Guideline 405 (Acute Eye Irritation / Corrosion). 0.1 mL was instilled into the conjuctival sac of the right eye of each rabbit.The left eye of each rabbit served as a control. Unrinsed, the eyes were scored (Draize scoring system) for irritation reactions at 1, 24, 48 and 72 h, 7 and 14 d post-instillation. Average cornea score was observed to be 20, 40, 40, 73.3 and 80 at 24, 48 and 72 h, 7 and 14 d, respectively. Average iris score was observed to be 5, 5, 5, 8.3 and 9.2 at 24, 48 and 72 h, 7 and 14 d, respectively. Average conjunctiva score was observed to be 16, 20, 20, 20, 20 and 20 at 1, 24, 48 and 72 h, 7 and 14 d, respectively. In conclusion, under the conditions of the study, the eye irritation score of the test substance was calculated to be 109.2 / 110. The test substance was found to be highly irritating to eyes (Trzyna and Paa, 1976).

Justification for selection of skin irritation / corrosion endpoint:

Several studies available showing skin irritation.

Justification for selection of eye irritation endpoint:

Several studies available showing eye irritation.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

In studies conducted in rabbits, PETIA was moderately irritating to skin and highly irritating to eyes, with effects on the cornea, iris and conjunctivae not reversible within 14 days. Hence, it qualifies for classification as Skin Irrit. 2 – H315 (causes skin irritation) and Eye Damage 1 - H318 (causes serious eye damage) according to EU CLP (EC 1272/2008) criteria.