Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, aromatics (2-30 %)

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well-documented study report which meets basic scientific principles.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

sensitisation data (humans)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well-documented study report which meets basic scientific principles.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across source

Executive summary:

This data is being read across from the source study that testedHydrocarbons, C14-C20, n-alkanes, isoalkanes, cyclics, 2-30% aromaticsbased on analogue read across.

A 64 year old woman had a history of an eczematous rash after the application of sunscreen. The rash had appeared after 3 days of application of the sunscreen over the face, neck, and limbs and had been very pruritic. Patch tests with the European standard series gave positive reactions to formaldehyde, quaternium-15, imidazolidinyl urea, and diazolidinl urea. The ingredients of the sunscreen were obtained from the manufacturers and patch tests were performed. There were positive reactions to isohexadecane 10% alcohol + at D2 and D4 and isopropyl myristate 10% alcohol + at D4. Both of these substances tested negatively in 20 controls. To the knowledge of the investigators, this is the first and only case report of allergic contact dermatitis from both isohexadecane and isopropyl myristate.

 

Data source

Reference

Reference Type:

publication

Title:

Allergic contact dermatitis from isohexadecane and isopropyl myristate.

Author:

Bharati A; King C M

Year:

2004

Bibliographic source:

Contact dermatitis, (2004 Apr) Vol. 50, No. 4, pp. 256-7. Journal code: 7604950. ISSN: 0105-1873.

Materials and methods

Study type:

case report

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Case study.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C14-C20, n-alkanes, isoalkanes, cyclics, 2-30% aromatics

IUPAC Name:

Hydrocarbons, C14-C20, n-alkanes, isoalkanes, cyclics, 2-30% aromatics

Method

Type of population:

not specified

Ethical approval:

not specified

Route of administration:

dermal

Applicant's summary and conclusion

Executive summary:

A 64 year old woman had a history of an eczematous rash after the application of sunscreen. The rash had appeared after 3 days of application of the sunscreen over the face, neck, and limbs and had been very pruritic. Patch tests with the European standard series gave positive reactions to formaldehyde, quaternium-15, imidazolidinyl urea, and diazolidinl urea. The ingredients of the sunscreen were obtained from the manufacturers and patch tests were performed. There were positive reactions to isohexadecane 10% alcohol + at D2 and D4 and isopropyl myristate 10% alcohol + at D4. Both of these substances tested negatively in 20 controls. To the knowledge of the investigators, this is the first and only case report of allergic contact dermatitis from both isohexadecane and isopropyl myristate.