Registration Dossier
Registration Dossier
Diss Factsheets
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: 203-935-4 | CAS number: 112-11-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication meeting basic scientific principles (analytical purity of test substance not specified, study conducted in occupational population with dermatitis induction exposition not fully traceable).
Data source
Reference
- Reference Type:
- publication
- Title:
- Patch test results with the metalworking fluid series of the German Contact Dermatitis Research Group (DKG)
- Author:
- Geier, J.
- Year:
- 2 004
- Bibliographic source:
- Contact Dermatitis 51: 118–130
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- survey
- Principles of method if other than guideline:
- Based on the information of the interdisciplinary task force on allergy diagnostics in the metal branch, in 2001, the German Contact Dermatitis Research Group (DKG) compiled two metalworking fluid (MWF) test series with currently and previously used components, respectively. After 2 years of patch testing, the results obtained with these series were presented, based on data of the Information Network of Departments of Dermatology (IVDK). The patch test guidelines provided from ICDRG and DKG were followed.
- GLP compliance:
- no
Test material
- Reference substance name:
- Isopropyl myristate
- EC Number:
- 203-751-4
- EC Name:
- Isopropyl myristate
- Cas Number:
- 110-27-0
- Molecular formula:
- C17H34O2
- IUPAC Name:
- isopropyl myristate
- Details on test material:
- - Name of test material (as cited in study report): Isopropyl myristate
- Analytical purity: no data
Patch test substances were obtained from Hermal, Reinbek, Germany.
Constituent 1
Method
- Type of population:
- occupational
- Ethical approval:
- not specified
- Subjects:
- As study group, exclusively metalworkers tested because of suspected MWF dermatitis were selected.
In 2002 and 2003, altogether 16 848 patients were patch tested in the departments of dermatology forming the IVDK.
Of these patients, 251 (1.5%) fulfilled the criteria of the study and hence were included in this retrospective data analysis.
Of these, 206 were tested with the current MWF series and 155 with the historical MWF series.
The IVDK is a multicentre surveillance system on contact allergies, with more than 40 departments of dermatology in Germany, Austria and Switzerland participating. Patch test results and anamnestic data of all patients tested are recorded electronically in a standardized way and regularly transferred to the IVDK data centre at the University of Göttingen.
Among the study group, i.e. 251 metalworkers tested because of suspected MWF dermatitis, there were 63 turners (lathe operators) (25.1%), 26 milling cutters (10.4%), 25 tool makers (10.0%) and 6 grinders (2.4%). In the remainder, no specification was given beyond ‘metalworker, chipping technology’ or ‘machine operator in the metalworking branch’. 124 patients (49.4%) had been working in their occupation since before 1994, while 82 patients (32.7%) started working with MWF in 1994 or later. In the remaining 45 patients (17.9%), the beginning of the MWF exposure was not mentioned. In the study population, there were 231 men (92.0%) and 115 patients (45.8%) at the age of 40 years or more. The age ranged from 17 to 62 years with a median of 38 years (mean 38.8 ± 11.4 years).
74 patients (29.5%) were examined in the context of a medicolegal assessment. 47 patients (18.7%) had past or present atopic dermatitis. 201 patients (80.1%) suffered from hand dermatitis. According to the course and anatomical site of the skin disease on the one hand and the occupational exposure (and, partly, occupational contact allergies) on the other hand, occupational dermatitis was finally diagnosed in 187 patients (74.5%).
A final current diagnosis of ICD was made in 81 patients (32.3%), while ACD was diagnosed in 63 patients (25.1%).
The remainder currently had various other forms of skin disease, e.g. dyshidrotic eczema, atopic dermatitis [22 patients (8.8%) each] or psoriasis [5 patients (2.2%)], etc. - Controls:
- No controls performed
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test) ;
Patch tests were performed and read at least until day 3 (D3), according to the guidelines of the ICDRG and the DKG (Schnuch, 2001 [Hautarzt, 52, 864–866] and Wahlberg, 2001 [In: Textbook of Contact Dermatitis, 3rd edn, Rycroft R J G, Menné T, Frosch P J, Lepoittevin J-P (eds), Berlin, Springer, 435–468]). Patch test exposure time was 2 days in 208 patients (83%) and 1 day in 43 patients (17%) according to the routine test procedure in the respective centre.
ADMINISTRATION
- Vehicle / solvent: petrolatum
- Concentrations: 10%
- No. of patients tested with isopropyl myristate: 196
Results and discussion
- Results of examinations:
- No positive reactions were seen to isopropyl myristate (0 out of 196 patients with reactions).
The test series with current MWF allergens has to be kept up-to-date based on information from industry and to be kept concise by eliminating test substances which never cause positive reactions.
Any other information on results incl. tables
The test series with current MWF allergens was tested in 206 patients (82.1% of the study population), and 88 positive reactions to allergens of this series occurred in 48 patients (23.3% of 206). Among those 155 patients (61.8%) tested with the series containing former, historical MWF allergens, 19 positive reactions were seen in 16 patients (10.3% of 155). The DKG standard series was patch tested in 221 patients (88.0% of the study population), and 128 positive patch test reactions occurred in 77 of these patients (34.8%).
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.