4-tert-butylbenzaldehyde

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Older proprietary study conducted prior to development of guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Repeat exposure patch test in human volunteers

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

tert-butylbenzaldehyde

IUPAC Name:

tert-butylbenzaldehyde

Test material form:

other: liquid

Details on test material:

The test material was p-tert-butylbenzaldehyde, received from Givaudan Corporation on 8 August 1979, lot number 9942-79. Dosing preparations were described as a clear liquid (2% solution in dimethyl phthalate).

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

The subjects were 26 male and 36 females ranging in age from 16 to 72 years. They were selected based on their willingness to participate, dependability and ability to read and understand instructions, absence of any physical or dermatological condition which would preclude application and reading, understanding and signing an informed consent contract (in the case of minors, parental consent was obtained).

Clinical history:

Subjects were free from any physical or dermatological condition which would preclude application of the test material.

Controls:

None.

Route of administration:

dermal

Details on study design:

Induction phase: patches were applied to either the inner arm or the back between the scapulae and waist (depending on volunteer preference). Approximately 0.2 g of test material (2% solution in dimethyl phthalate) was placed onto 2 cm² of Webril affixed to Dermicel tape. The patch was applied and held in place with strips of Blenderm to form an occlusive patch. The patch was removed after 24 hours. Following a rest period of either 24 hours (patches removed on Tuesdays or Thursdays) or 48 hours (patches removed on Saturdays), the test site was scored for signs of irritation and another patch identical to the first was applied. The procedure was repeated until 10 applications had been made. If no irritation was observed subsequent patches were applied to the same site. If a reaction of 2+ or greater was observed then the subsequent patch was applied to a new site and the position recorded. If a minimum of a 2+ reaction was observed in the new site, no further exposures were made (however challenge was still carried out).

Challenge: 10-14 days after application of the final induction patch, the challenge patch was applied to the original contact site and to a fresh, adjacent site. The occlusive patches remained in place for 24 hours, and the sites were scored 24 and 48 hours after application. Subjects were asked to report any delayed reactions occurring after the 48 hour reading.

Results and discussion

Results of examinations:

No adverse reactions were observed in any subjects.

Any other information on results incl. tables

No further information.

Applicant's summary and conclusion

Conclusions:

No adverse reactions were observed in any subject, therefore it was concluded that 2% p-tert-butylbenzaldehyde is not irritating or sensitising to humans.

Executive summary:

Twenty six male and thirty six female subjects were exposed dermally to p-tert-butylbenzaldehyde in order to determine its skin irritating and sensitising potential. The test substance (2% solution in dimethyl phthalate) was applied to the skin under an occlusive dressing for ten 24 hour periods, with a rest period of either 24 or 48 hours between exposures. Signs of irritation were recorded prior to application of the patches. A challenge application was made 10 - 14 days after the final induction patch. No signs of irritation or adverse reactions were observed in any subject, therefore it was concluded that a 2% solution of the test material is not irritating or sensitising to human skin.