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EC number: 946-248-1 | 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:
- From March 9, 1983 to April 2, 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The in vivo study (GPMT) was conducted prior to the implementation of the LLNA method
Test material
- Reference substance name:
- Citronellyl 3-methylcrotonate
- EC Number:
- 244-019-4
- EC Name:
- Citronellyl 3-methylcrotonate
- Cas Number:
- 20770-40-5
- Molecular formula:
- C15H26O2
- IUPAC Name:
- 3,7-dimethyloct-6-en-1-yl 3-methylbut-2-enoate
- Reference substance name:
- 3,7-dimethyloctyl 3-methyl-2-butenoate
- EC Number:
- 275-360-7
- EC Name:
- 3,7-dimethyloctyl 3-methyl-2-butenoate
- Cas Number:
- 71383-07-8
- Molecular formula:
- C15H28O2
- IUPAC Name:
- 3,7-dimethyloctyl 3-methylbut-2-enoate
- Reference substance name:
- 3,7-dimethyloct-7-en-1-yl 3-methylbut-2-enoate
- Cas Number:
- 74499-48-2
- Molecular formula:
- C15H26O2
- IUPAC Name:
- 3,7-dimethyloct-7-en-1-yl 3-methylbut-2-enoate
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
- Specific details on test material used for the study:
- A 200ml sample of the test substance was received from the sponsor on December 17, 1982. It was a clear colourless liquid, designated: Sinodor X-09648, No. 211234, date 13.12.82.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Remarks:
- Mouse, CBA/J strain, inbred, SPF-Quality.
- Sex:
- male
- Details on test animals and environmental conditions:
- Main test is conducted with 15 young male SPF bred albino guinea pigs (body weight 200-400g) obtained from the central intitute for the Breeding of Laboratory Animals TNO, Zeist, The Netherlands.
The experiment is preceded by an acclimatization period of at least two days to accustom the animals to the environmental conditions prevailing in our laboratory.
The guinea pigs are kept under conventional conditions and individually housed in suspended stainless steel cages, fitted with wire mesh floors and fronts. The temperature in the animal room is kept at 21 +/- 1 °C, the relative humidity at 40% at least and a 12 h light/dark cycle is maintained.
The guinea pigs are fed pelleted stock diet from Hope Farms (Woerden, The Netherlands). The diet as well as tap water are provided ad libitum throughout the experiment.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 10%
- Day(s)/duration:
- 24h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: Mixture of FCA and Propylene Glycol (1:1)
- Concentration / amount:
- 10%
- Day(s)/duration:
- 24h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: FCA
- Concentration / amount:
- 0%
- Day(s)/duration:
- 24h
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 25%
- Day(s)/duration:
- 48h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 10%
- Day(s)/duration:
- 24h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Control group: 5 animals
Test group: 10 animals - Details on study design:
- The test was divided into two stages:
a) induction treatment by intradermal injection and topical application
b) challenge treatment by topical application
Induction is effected in a two-stage operation consisting of, firstly, three pairs of intradermal injections made simultaneously and, secondly, one week later, a closed patch exposure performed over the injection sites. For this purpose an area of c. 24 cm2 of dorsal skin in the shoulder region is clipped free of hair with electric clippers.
The induction by intradermal injection was performed in two rows of each three injection sites in the shoulder region as follows:
Test animals:
- two injections (0.1 ml) of Freund's Complete Adjuvant (FCA)
- two injections (0.1 ml) of a 10% dilution (w/v) of Sinodor in propylene glycol (PG)
- two injections (0.1 ml) of a 10% dilution (w/v) of Sinodor in FCA and PG (1:1)
Control animals:
- two injections (0.1 ml) of Freund's Complete Adjuvant (FCA)
- two injections (0.1 ml) of propylene glycol (PG)
- two injections (0.1 ml) of FCA and PG (1:1)
Skin readings are made 24h after the treatment.
One week after the intradermal injections, the induction by topical application was made in the same shoulder region. The test animals were treated with a 25% dilution (w/w) of Sinodor in vaseline. The controls were similarly treated with vaseline alone.
The test animals are treated as follows: a 2x4cm patch of Whatman No 3 MM filter paper is loaded with the appropriate mixture of the test substance and carrier. The patch is placed over the sites of the intradermal injections and covered with a piece of PVC foil and a piece of Leukopor hypo-allergic paper bandage. This, in turn, is secured with a 7.5cm wide Tensoplast bandage. The dressing is left in place for 48h. The control animals are similarly treated with patches with carrier only. Skin readings are made after removal of the patches.
The challenge was carried out two weeks after the topical induction in both test and control animals. The right flank of all animals was topically treated with a 10% dilution (w/w) of Sinodor in vaseline.
An area of 5x5 cm on the left flank of each animal is clipped free of hair and closely shaved. Subsequently a Silverpatch is loaded with the appropriate mixture of the test substance and carrier and place in the centre of the shaved area. The patch is covered with Leukopor bandage which is held in place by Tensoplast. The control animals are also treated with the test substance. The patches are left in place for 24 h. Skin readings are made immediately after removal of the patches and 24 and 48h thereafter.
The response are given a score according to Draize et al. (1944). - Challenge controls:
- The challenge was carried out two weeks after the topical induction in both test and control animals. The right flank of all animals was topically treated with a 10% (w/w) of Sinodor in Vaseline. The patches are left in place for 24h. Skin readings are made immediately after removal of the patches and 24 and 48h thereafter.
One of the five control animals reacted positively immediately after removal of the dressing.
After 24 and 48 h, none of the control animals showed erythema reactions. - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No postive controls done.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- Very slight erythema immediately after removal of the dressing
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Very slight erythema immediately after removal of the dressing
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Like 24 hours after removal of the challenge dressing, none of the test and control animals showed erythema reactions after 48 hours too.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Since none of the test animals showed erythema reactions in the challenge test at the 24 hours reading, it is concluded that the test substance did not induce delayed contact hypersensitivity in any of the guinea pigs under the conditions of the test.
- Executive summary:
The test substance Sinodor was examined for possible senitization potential by a maximisation test in guinea pigs.
From the reaction to the challenge treatment with a 10% dilution of the test substance in vaseline, it was concluded that the test substance did not induce delayed contact hypersensitivity in guinea pigs under the conditions of the test.
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