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Toxicological information

Sensitisation data (human)

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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:
read-across: supporting information
Reference
Endpoint:
sensitisation data (humans)
Type of information:
read-across based on grouping of substances (category approach)
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:
read-across source
Study type:
case report
Qualifier:
no guideline followed
Principles of method if other than guideline:
Case study.
GLP compliance:
not specified
Type of population:
not specified
Ethical approval:
not specified
Route of administration:
dermal
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.

 

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

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
not specified
Ethical approval:
not specified
Route of administration:
dermal

Results and discussion

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.