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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
The justification for read across is provided 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:
The justification for read across is provided 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 tested Hydrocarbons, C14-C20, n-alkanes, isoalkanes, cyclics, 2-30% aromatics based 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

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

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.