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EC number: 939-618-9 | CAS number: -
- 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:
- Mar 1981 to 30 Apr 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study pre-dates the adoption of the LLNA OECD 429 (2002).
Test material
- Reference substance name:
- α,3,3-trimethylcyclohexylmethyl acetate
- EC Number:
- 246-737-3
- EC Name:
- α,3,3-trimethylcyclohexylmethyl acetate
- Cas Number:
- 25225-10-9
- Molecular formula:
- C12H22O2
- IUPAC Name:
- 1-(3,3-dimethylcyclohexyl)ethyl acetate
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Animals were housed in suspended cages with wire mesh floors, with free access to tap water and Vitamin C-enriched Guiney-pig Diet Standard F.D.I. No 803189W. Hay was given once a week.
Animal room temperature was 21°C and the air exchange was maintained at 15 air changes/hour.
Lighting was controlled using a 12 hour light/dark cycle.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 10% v/v in liquid paraffin
10% v/v in a 50:50 mixture of Freund's adjuvant and liquid paraffin - Day(s)/duration:
- Once
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Day(s)/duration:
- 4 hours
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 10% v/v in liquid paraffin
20% v/v in liquid paraffin
- No. of animals per dose:
- 15 test animals and 15 control animals
- Details on study design:
- Induction
A 4x6 cm area of dorsal skin on the scapular region of the guiney-pig was clipped free of hair with electric clippers. Three pairs of intradermal injections were made simultaneously into this area. Injections were as follows: 1) Freund's complete adjuvant was diluted with an equal volume of water for injection; 2) The substance 10% v/v in liquid paraffin and; 3) The substance 10% in a 50:50 mixture of Freund's adjuvant and liquid paraffin.
Topical application was applied one week after the injections, the same 4x6 cm interscapular area was clipped and shaved free of hair. A 2x4 cm patch of Whatmen No 3 mm paper was saturated with the substance as supplied (100%). The patch was placed on the skin and covered by a length of impermeable plastic adhesive tape (5 cm width 'Blenderm'). This in turn was firmly secured by elastic adhesive bandage ('Elastoplast' of 5 cm width) wound around the torso of the animal and fixed with 'Sleek" impervious plastic adhesive tape. The dressing was left in place for 4h hours.
The control animals were treated similarly but with the exception that the substance was omitted from the intradermal injection and the topical application.
Challenge
Challenge applications were applied 2 weeks after last exposure using 20 and 10% in liquid paraffin. The challenge sites were evaluated 24, 48 and 72 hours after removal of the patches. - 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:
- 0.2 mL 20% v/v in liquid paraffin
- No. with + reactions:
- 3
- Total no. in group:
- 14
- Clinical observations:
- Localised dermal reaction (restricted to a small area)
- Remarks on result:
- other: One animal of the test group was found dead. See 'Any other information on results incl. tables'
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 mL 20% v/v in liquid paraffin
- No. with + reactions:
- 3
- Total no. in group:
- 14
- Clinical observations:
- Localised dermal reaction (restricted to a small area)
- Remarks on result:
- other: One animal of the test group was found dead. See 'Any other information on results incl. tables'
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.2 mL 20% v/v in liquid paraffin
- No. with + reactions:
- 0
- Total no. in group:
- 14
- Clinical observations:
- dryness and sloughing of the epidermis
- Remarks on result:
- other: One animal of the test group was found dead. See 'Any other information on results incl. tables'
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.2 mL liquid paraffin
- No. with + reactions:
- 4
- Total no. in group:
- 14
- Clinical observations:
- Localised dermal reaction (restricted to a small area)
- Remarks on result:
- other: One animal of the control group was killed. See 'Any other information on results incl. tables'
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.2 mL liquid paraffin
- No. with + reactions:
- 3
- Total no. in group:
- 14
- Clinical observations:
- Localised dermal reaction (restricted to a small area)
- Remarks on result:
- other: One animal of the control group was killed. See 'Any other information on results incl. tables'
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.2 mL liquid paraffin
- No. with + reactions:
- 3
- Total no. in group:
- 14
- Clinical observations:
- Localised dermal reaction (restricted to a small area) and one animal showed dryness and sloughing of the epidermis
- Remarks on result:
- other: One animal of the control group was killed. See 'Any other information on results incl. tables'
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: no positive control was used
Any other information on results incl. tables
Mortality
One animal of the test group was found dead and one animal of the control group was killed. The mortality was not related to the substance.
Table 1. Number of animals with a skin reaction to a challenge with the substance
Animals |
Skin reaction |
Scores |
|
|
|
|
|
Result |
Scoring after (hours Challenge concentrations |
|
24h 10% |
24h 20% |
48h 10% |
48h 20% |
72h 10% |
72h 20% |
|
Controls |
|
7/14 |
4/14 |
6/14 |
3/14 |
5/14 |
3/14 |
- |
Test animals |
Reaction* |
4/14 |
3/14 |
5/14 |
3/14 |
5/14 |
0/14 |
- |
*Skin reaction mainly consisted of localised dermal reactions (restriction to small area of the challenge site)
Applicant's summary and conclusion
- Interpretation of results:
- other: no skin sensitiser
- Remarks:
- In accordance with EU CLP (EC no 1272/2008 and its amendments)
- Conclusions:
- The substance is not a skin sensitiser in the GPMT test (OECD TG 406).
- Executive summary:
A GPMT was performed in accordance with OECD TG 406. Fifteen test and fifteen control animals were used. Dose levels for the induction phase were: intradermal 10% v/v in liquid paraffin and 10% v/v in a 50:50mixture of Freund's complete adjuvant and liquid paraffin, topical application as supplied and challenge application as 10% and 20% v/v in liquid paraffin. In the induction phase, the substance was applied to the dorsal skin on the scapular region (intradermal injection) or the interscapular area (topical application) of the guinea-pig clipped and shaved free of hair. Erythema and oedema were scored 24, 48 and 72 hours after the challenge. One animal of the test group was found dead and one animal of the control group was killed. The mortality was not related to the substance. As a consequence, 14 instead of 15 animals per group were scored. In the test animals and controls localised dermal reactions were seen, which were thought to be related to skin irritation rather than sensitisation because the number and frequency of the findings were similar in the treated groups and the test animals. In conclusion, the substance is not considered a sensitiser.
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