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EC number: 201-730-4 | CAS number: 87-20-7
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15.11.-29.12.2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
- Remarks:
- according to GCP ICH guideline E6
Test material
- Reference substance name:
- Isopentyl salicylate
- EC Number:
- 201-730-4
- EC Name:
- Isopentyl salicylate
- Cas Number:
- 87-20-7
- Molecular formula:
- C12H16O3
- IUPAC Name:
- isopentyl salicylate
Constituent 1
Method
- Type of population:
- general
- not specified
- Ethical approval:
- not specified
- Subjects:
- 112 qualified subjects, male and female, ranging from 18 to 70 years
107 subjects completed the study, the reason for discontinuation were not related to the application of the test - Clinical history:
- Inclusion criteria:
- 16 to 79 years (male and female)
- absence of any visible skin disease (confusion with skin reaction)
- prohibition of use of topical or systemic steroids and/or antihistamines for at least 7 d prior to study initiation
- completion of a Medical history Form and the understanding and signing of an informed Consent Form
- considered reliable and capable of following directions
Exclusion criteria:
- ill health under doctor's care or taking medication(s) which could influence the outcome of the study
- pregnant or nursing females
- a history of adverse reactions to cosmetics or other personal care products - Controls:
- not specified
- Route of administration:
- dermal
- Details on study design:
- Methodology:
- test item concentration: 20% in DEP/EtOH 3:1
- approx. 0.2 ml of test material was applied to the upper back to a 1" x 1" absorbent pad portion of a clear, adhesive dressing which was applied to form a semi-occlusive patch
Induction phase:
- patches applied 3 times per week (Monday, Wednesday, Friday) for a total of 9 applications
- first scoring after 24 h after application
- evaluation before re-application
- rest periods of one day following each Tuesday and Thursday removal
Challenge phase:
- approx. 2 weeks after final induction patch application, a challenge patch was applied to a virgin test site adjacent to the original induction patch site following the same procedure as described for induction
- the patch was removed and the site scored at the clinic day 1 and day 3 post-application
Evaluation criteria (erythema and additional dermal sequelae):
0= no cicible skin reaction
0.5= barely perceptible
1= mild
2= moderate
3= marked
4= severe
E= edema
D= dryness
S= staining
P= papules
V= vesicles
B= bullae
U= ulceration
Sp= spreading
Erythema was scored numerically according to this key. If present, additional dermal sequelae were indicated by the appropriate letter code and a numerical value for severity.
Results and discussion
- Results of examinations:
- Observations remained negative throughout the test interval.
Few deviations from the study protocol were judged by the principal investigator as not affecting the test results, since observations remained negative.
Applicant's summary and conclusion
- Conclusions:
- Under the condtions of the study, the test material indicated no potential for dermal irritation or allergic sensitization.
- Executive summary:
A Human Repeat Insult Patch Test (HRIPT) to determine by repetitive epidermal contact the potential of a test material to induce primary or cumulative irritation and/or allergic contact sensitization was performed. The study followed a generally accepted scientific test protocol and is described in sufficient detail. The test was performed accordng to GCP standard ICH E6.
112 qualified subjects, male and female, ranging from 18 to 70 years started and 107 subjects completed the study, the reason for discontinuation were not related to the application of the test.
Approximately 0.2 ml of test material at a concentration of 20% in DEP/EtOH 3:1was applied to the upper back to a 1" x 1" absorbent pad portion of a clear, adhesive dressing which was applied to form a semi-occlusive patch.
Patches were applied 3 times per week (Monday, Wednesday, Friday) for a total of 9 applications. The first scoring was 24 h after application and evaluation was before re-application. Rest periods of one day following each Tuesday and Thursday removal.
Approximately 2 weeks after final induction patch application, a challenge patch was applied to a virgin test site adjacent to the original induction patch site following the same procedure as described for induction. The patch was removed and the site scored at the clinic day 1 and day 3 post-application Erythema was scored numerically according to the key. If present, additional dermal sequelae were indicated by a appropriate letter code and a numerical value for severity.
Adverse events: subject #22 reported for a final post challenge observation. Diffuse erythema on the right side of her back (area about 4" x 6") and few small papules were also present but not associated with any patched test site, occurred two days after removal of the last patch. It was judged as unlikely to be related to the test material. Observations remained negative throughout the test interval.
Under the condtions of the study, the test material indicated no potential for dermal irritation or allergic sensitization.
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