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Diss Factsheets
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EC number: 204-000-3 | CAS number: 112-72-1
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2-Jun-2003 to 11-Jul-2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliable GLP study conducted according to a published protocol, on a related material
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Modified Draize patch test (Marzulli FN and Mailbach HI (1977). Contact allergy: predictive testing in humans. In: Advances in Modern Toxicology, Dermatotoxicology and Pharmacology, 4, 353-372, eds. Marzulli FN and Mailbach HI).
- GLP compliance:
- yes
- Remarks:
- Good Clinical Practice
Test material
- Reference substance name:
- Alcohols, C16-19-branched
- EC Number:
- 297-790-4
- EC Name:
- Alcohols, C16-19-branched
- Cas Number:
- 93762-74-4
- IUPAC Name:
- 93762-74-4
- Test material form:
- other: cream
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Subjects:
- - Number of subjects exposed: 103 subjects completed the study (124 started - non-completion not due to adverse events related to the test material)
- Sex: male/female
- Age: 18 years or older (not more than 20% of the subjects over the age of 65 years)
- Race: no data
- Demographic information: no data - Clinical history:
- Exclusion criteria:
insulin-dependent diabetes
mastectomy for cancer with removal of lymph nodes
active, clinically significant skin diseases
skin cancer
participation in patch test for irritation or sensitisation within the last 4 weeks
use of immunosuppressive drugs
regular high use of anti-inflammatory drugs, use of antihistamines or allergy injections
asthma ,requiring frequent or chronic medication
immunological disorders e.g., HIV positive, AIDS, rheumatoid arthritis and systemic lupus erythematosus
use of topical drugs on patch site
pregnancy or lactation
allergy to adhesives, bandages
any condition or medication which, in the investigator's judgement, makes the subject ineligible or at risk. - Controls:
- none
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: semi-occlusive
- Description of patch: no data of the patch materials used
- Vehicle / solvent: CLI 1500301 moisturizer base
- Concentrations: 0.5%
- Volume applied: 0.2 ml
- Testing/scoring schedule: patches were generally applied on Mondays, Wednesdays and Fridays and removed by the subjects about 24 or 48/72 hours later. A total of 9 patches were applied during a 4-week period to the same site on the back unless irritation reactions were cosidered to be grade 2 or above, when an adjacent site was used.
A rest period of between 10 and 21 days occurred between the last induction patch and the application of the challenge patch which was applied to a new site on the opposite back area. Patches were removed 24 or 48 hours later. During induction any skin responses were scored prior to patch re-application; after challenge reactions were scored about 48 and 72 or 96 hours after patch application.
The scoring grades are given below
- Removal of test substance: no data; presumably removed by showering/bathing
EXAMINATIONS
- Grading/Scoring system:
0 No visible reaction and/or erythema
+ Slight, confluent or patchy erythema
1 Mild reaction, macular erythema (faint pinkness)
2 Moderate reaction - macular erythema (definite redness)
3 Strong to severe reaction - macular erythema (very intense redness)
- Statistical analysis: no data
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: see Table 1 for subjects showing positive reactions during induction or challenge
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/103 after challenge
- Number of subjects with negative reactions: 103/103 after challenge
- Number of subjects with equivocal reactions: 0/103
- Number of subjects with irritating reactions: 2/103 after challenge
OTHER RESULTS:
Of the two subjects showing a positive reaction after challenge, in one (No. 79) the reaction had reduced by 96 hours and in the other subject (No. 96) it had resolved by 192 hours.
Any other information on results incl. tables
Table 1. Subjects showing erythema during induction or challenge (subjects showing only negative results are not included)
Subject |
Induction day |
Challenge |
|||||||||
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
48 hr |
96 hr |
12 |
0 |
0 |
0 |
0 |
0 |
0 |
+ |
0 |
0 |
0 |
0 |
25 |
0 |
1 |
1 |
d |
|||||||
30 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
+ |
0 |
0 |
0 |
68 |
0 |
+ |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
70 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
74 |
0 |
0 |
0 |
0 |
1 |
2 |
1 |
1 |
1 |
0 |
0 |
79 |
1 |
1 |
1 |
0 |
1 |
+ |
+ |
+ |
0 |
2 |
1 |
83 |
0 |
0 |
0 |
+ |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
85 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
+ |
0 |
0 |
90 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
+ |
0 |
0 |
97 |
0 |
0 |
+ |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
110 |
0 |
+ |
+ |
0 |
0 |
+ |
0 |
0 |
0 |
0 |
0 |
112 |
0 |
0 |
+ |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 No visible reaction and/or erythema; + Slight, confluent or patchy erythema; 1 Mild reaction, macular erythema (faint pinkness); 2 Moderate reaction - macular erythema (definite redness); d Dropped out
Applicant's summary and conclusion
- Conclusions:
- In a reliable study conducted to GLP, Neodol 67 (C16-17 alcohols, branched) applied at 0.5% exhibited no sensitising potential in a repeated insult patch test in over 100 human volunteers.
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