Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 931-434-7 | CAS number: -
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only short abstract available (analytical purity of test substance not specified).
Data source
Reference
- Reference Type:
- other: Study summary/letter
- Title:
- Unnamed
- Year:
- 1 959
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Repeated human patch test with 50 volunteers, 72h induction, after 7 days 72h challenge.
- GLP compliance:
- no
Test material
- Reference substance name:
- Esterification products of D-glucitol with C8 – C16 (even-numbered) and C18 unsaturated fatty acids
- EC Number:
- 931-434-7
- Cas Number:
- 1338-39-2
- Molecular formula:
- C18H34O6
- IUPAC Name:
- Esterification products of D-glucitol with C8 – C16 (even-numbered) and C18 unsaturated fatty acids
- Reference substance name:
- 931-434-7
- EC Number:
- 931-434-7
- IUPAC Name:
- 931-434-7
- Details on test material:
- - Name of test material (as cited in study report): sorbitan monolaurate
- Analytical purity: not specified
- Lot/batch No.: 342, CEL #71287
Note: Due to analytical test results the substance is defined as UVCB. For further details see IUCLID Chapter 1.2.
Constituent 1
Constituent 2
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 50
- Controls:
- no data
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: one inch square patch of absorbent cotton twill sealed onto the skin with an elastic adhesive 2 inch square patch
- Vehicle / solvent: none
- Concentrations: undiluted
- Volume applied: no data
- other: 72 h induction, after 7 days 72 h of challenge in the same manner as used for induction procedure and on the same area of the skin
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 50
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test substance is not sensitising to human skin.
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.
