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EC number: 291-443-0 | CAS number: 90411-66-8
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 June 1992 - 24 July 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 12 May 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study pre-dates the adoption of the LLNA method and associated testing guidelines.
Test material
- Reference substance name:
- Hexanoic acid, 2-ethyl-, C12-15-alkyl esters
- EC Number:
- 291-443-0
- EC Name:
- Hexanoic acid, 2-ethyl-, C12-15-alkyl esters
- Cas Number:
- 90411-66-8
- IUPAC Name:
- Hexanoic acid, 2-ethyl-, C12-15-alkyl esters
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Characterisation:
- Number: 20
- Weight: 200-300g
- Supplier: Breeding "Padre Antonio" Mariano Comense (Co) Italy
Selection justification:
These guinea pigs were used as recommended by the Ministerial decree, 5 December 1983 and in accordance with OECD Guidelines.
Housing:
The animals were caged, in groups of ten, in transparent polycarbonate cages (dimensions: 590x385x200h mm). The housing room was maintained under the following conditions:'
Temperature: 22 °C ± 2 °C
Humidity : 55% ± 15%
Air was changed at least 25 times per hour and maintained at pressure higher than the outside atmosphere.
Artificial lighting: 12 h/day.
Recordings of the housing conditions are being retained in 'Biolab s.o.s.' files.
Cleaning and disinfection:
The cages and the housing rooms were cleaned and disinfected before the animals were accomodated, then cleaning and disinfection were performed periodically.
Feeding:
Animals were fed, with a .standard complete pellet diet supplied by the company MUCEDOLA.
Water supply:
Animals were supplied with filtered water from an automatic watering system.
Quarantine:
Before allocation to the study, the animals were kept in quarantine for one week. During this period. they‘ were observed daily.
At the end. of the quarantine week the animals were carefully examined in order to evaluate their suitability for the study.
Animal selection:
The animals allocated to the study were selected randomly from those suitable, available at that time.
Animal identification:
The selected animals were caged in groups of ten per cage; each cage was identified with a label. The animals were identified by means of a numbered plastic tag stuck on their right ear.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml
- Day(s)/duration:
- Day 0 / 6 hours
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml
- Day(s)/duration:
- Day 7 / 6 hours
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml
- Day(s)/duration:
- Day 14 / 6 hours
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml
- Day(s)/duration:
- Day 28 / 6 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- Skin preparation:
24 hours before testing, fur was removed by shaving a 50cm wide area on the back of the animals.
Administration:
The test consisted of an induction phase and a challenge phase.
Induction phase:
Day 0 - 7 - 14 treated group:
0.5 ml of test material was applied to all animals by means of an occlusive bandage.
The bandage was left in place for 6 hours.
Day 0 - 7 - 14 control group:
The same treatment was used with the control group but using distilled water instead of test material.
Challenge phase:
Day 28 - treated and control group:
All 20 guinea pigs were treated by applying test material on the skin on the right side of the animal while 0,5 ml of distilled water was placed on the skin on the left side. This is done by using an occlusive bandage. The bandage was left in place for 6 hours. - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No effects observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No effects observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No effects observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No effects observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No effects observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.5 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No effects observed
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Full tables appended in background information.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- During the study no signs of erythema and/or oedema were observed in treated and control animals.
The data concerning every single animal are reported in appendices l and 2. - Executive summary:
An allergic sensitization test was carried out on test material COSMACOL EOI.
20 guinea pigs were used in the test, 10 as controls and 10 were treated with the test material.
The test consisted, of 2 phases, an induction phase and a challenge phase.
During the induction phase the test material was applied on the skin at a dose of 0,5 ml/animal.
The dressing was left in place for 6 hours.
The same operation was repeated after 7 and 14 days.
The 10 control animals received the same treatment but distilled water was used instead of the test material.
28 days after the beginning ofi treatment a challenge phase was carried out on both groups of animals.
0,5 ml of test material was applied on the left flank of each animal and 0.5 ml of water was applied to the right side.
The dressing was left in place for 6 hours.
24, 48 anfi 72 hours after the challenge phase began, all animals are evaluated.
No signs of erythema or oedema were found. Therefore the test material can be classified as non-sensitizing.
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