Registration Dossier
Registration Dossier
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EC number: 246-770-3 | CAS number: 25265-71-8
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study published in peer-reviewed literature, brief reporting, but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Contact sensitization to dipropylene glycol in an ecxema population
- Author:
- Johansen JD, Jemec GBE, Rastogi SC
- Year:
- 1 995
- Bibliographic source:
- Contact Dermatitis, 33, 211-212
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- In a pilot study 34 excema patients were patch tested with two grages of dipropylene glycol as 10%, 5%, 2% and 1% aqueous solution. When no reactions were seen, the standard series at Gentofte was supplemented with 10% aqueous solution of dipropylene glycol for 7 months. 503 consecutive excema patients were tested, patches being applied for 2 days, and reactions being read at days 2, 3 and 5-7.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Oxydipropanol
- EC Number:
- 246-770-3
- EC Name:
- Oxydipropanol
- Cas Number:
- 25265-71-8
- Molecular formula:
- C6H14O3
- IUPAC Name:
- 1,1-Oxydi-2-Propanol
- Details on test material:
- - Name of test material (as cited in study report): dipropylene glycol, DG
- Analytical purity: 2 grades were used: synthesis grade purity > 97% and cosmetic grade purity 96%
- Suppliers: E. Merck (Darmstadt, Germany) and from own case, respectively
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 34 in the pilot study, 503 in consecutive study
- Sex: 212 males, 291 females - Clinical history:
- - History of allergy or casuistics for study subject or populations: the study was prompted by a case of allergic contact dermatitis from dipropylene glcyol in a hand lotion. 503 eczema patients were tested
- Controls:
- No data
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: patches were applied using Scanpor test and Finn Chambers
- Vehicle / solvent: water
- Concentrations: 10%, 5%, 2% and 1% in a pilot study, 10% in the consecutive study
- Testing/scoring schedule: patches were applied for 2 days and reactions scored at days 2, 3 and 5-7.
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION (cosmetic grade / synthesis grade):
- Number of subjects with positive reactions: 0 / 1
- Number of subjects with negative reactions: 488 / 480
- Number of subjects with equivocal reactions: 13 / 17
- Number of subjects with irritating reactions: 2 / 5
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
