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Description of key information

Skin irritation: Dermal irritation tests with humans revealed some dermal irritation potential for DIPA.

Skin sensitisation: 2% DlPA (aqueous solution) did not induce allergic or photoallergic dermatitis. Case reports with formulations containing DIPA are available, two human patch tests were performed including control subjects.

Additional information

Skin Irritation (IUCLID section 7.10.5):

In a human patch test (Cronin, 1980) 24 volunteers received undiluted DIPA to the skin and dermal irritation was observed in six individuals.

Skin Sensitisation (IUCLID section 7.10.3):

DlPA (2% aqueous solution) did not induce allergic or photoallergic dermatitis (Maibach, 1986; cited in J.Am.Coll.Toxicol., 1987: 6(1), 53 -76).

In a case report (Cronin, 1980; RL2), a 15 years old girl complained of irritation of her eyelids and face for six months and attributed this to her cosmetics. When patch tested, she reacted only to her eye gloss; she was then tested to its ingredients, and reacted to diisopropanolamine, undiluted. This substance also gave a positive open test; as it is an irritant, it should have been diluted for patch testing. It was, in fact, tested undiluted on 24 control subjects of whom six gave irritant responses. Nevertheless, the patient's reaction did not look irritant, it was eczematous and spread beyond the patch test site; for this reason it was considered an allergic response.

In another case report (Fujimoto, 1989; RL4) a 60-year-old man with gout used indomethacin ointmnet containing 1% diisopropanolamine. A diffuse and edematous erythema, accompanied by a febrile sensation and severe itching was present. A patch-test with 1% diisopropanolamine in vaseline gave positive reaction. Of 12 control subjects patch tested with DIPA I% pet., 11 were negtive and 1 gave a false positive reaction.

Several studies with sunscreen lotion containing 1 -2% DIPA are available (cited in J.Am.Coll.Toxicol., 1987: 6(1), 53 -76), however, details about test material (e.g. other ingredients than DIPA) are not available. Thus, these data are not included to the dossier.