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EC number: 255-138-6 | CAS number: 40910-49-4
- 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:
- weight of evidence
- Study period:
- March 11, 1980 - April 04, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed similar to OECD 406 guideline. Non GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no positive control, 2nd challenge quickly after 1st challenge with lower concentration.
- Principles of method if other than guideline:
- The test was mainly conducted according to the method described by Magnusson and Kligman, "Allergic contact dermatitis in guinea pigs", Ed. Ch.C. Thomas, Springfield, Illinois, USA (1970).
- GLP compliance:
- no
- Remarks:
- not present at the time of performance.
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA method not available at time of testing
Test material
- Reference substance name:
- 3-(1-ethoxyethoxy)-3,7-dimethylocta-1,6-diene
- EC Number:
- 255-138-6
- EC Name:
- 3-(1-ethoxyethoxy)-3,7-dimethylocta-1,6-diene
- Cas Number:
- 40910-49-4
- Molecular formula:
- C14H26O2
- IUPAC Name:
- 1-[(3,7-dimethylocta-1,6-dien-3-yl)oxy]-1-ethoxyethane
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Elintaal F
- Description: Slightly yellow liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino SPF
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Central Institute for the breeding of laboratory animals TNO, Zeist, The Netherlands
- Age at study initiation: young male animals
- Weight at study initiation: 300 - 415 g
- Housing: Individually housed in suspended stainless steel cages, fitted with wire mesh floors and fronts
- Diet: Pelleted stock diet (Hope Farms, Woerden, The Netherlands) ad libitum
- Water: Tap water ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 - 25
- Humidity (%): 40 -70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- 5% for the intradermal induction and 10% for the epidermal induction.
10% and 5% for the challenge phase.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 5% for the intradermal induction and 10% for the epidermal induction.
10% and 5% for the challenge phase.
- No. of animals per dose:
- Test animals: 10
Control animals: 5 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
1) Intradermal injections on day 1:
- Site: shoulder region shaved with electric clippers
Three pairs of intradermal injections:
1) 0.05 mL: Freund's Adjuvant
2) 0.05 mL: test substance at a 5% concentration (control animals: 0.05 mL propylene glycol)
3) 0.05 mL: 1:1 mixture of 5% concentration of the test substance Freund's Adjuvant
2) Topical application on day 8:
- Site: shoulder region shaved with electric clippers
- Amount: 10% test substance dilution in vaseline
- Area: approximately 8 cm^2
- Exposure period: 48 hours (occlusive)
B. CHALLENGE EXPOSURE
- Day of challenge: day 21, all animals, with the 10% test substance mixed with vaseline
- Exposure period: 24 hours (occlusive)
- Site: right flank
- Amount: gently massaged in with a glass rod
- Readings: 24 hours after patch removal
RECHALLENGE: day 23, all animals, with the 5% test substance mixed with vaseline
OBSERVATIONS
Skin reactions were judged by the method of Draize, as described in J. Pharmacol. 82 (1944) 377-390 - Challenge controls:
- Not applicable.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Preliminary test:
A concentration of 5% was chosen for intradermal induction, because this concentration induced only moderate irritation.
A concentration of 10%, which proved to be non-irritating in the topical induction, was used for the challenge.
Main test:
The intradermal injections given in the induction phase resulted in:
- FCA: erythema and edema;
- 5% test substance in propylene glycol: slight erythema and abscesses;
- 5% test substance in propylene glycol + FCA: slight erythema, slight edema and abscesses
The 10% concentration in vaseline induced neither erythema nor edema upon topical application in the induction phase.
In the first challenge, the 10% concentration provoked very slight erythema in 3 animals in the test group. The control animals showed no reaction.
The 5% concentration in the rechallenge showed no reaction in the test animals or in the control animals.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a guinea pig maximisation test method the potential of Elintaal F for skin sensitisation was tested similar to OECD 406 guideline, showing very slight erythema in 3 out of 10 animals. At the 5% challenge concentration, no sensitization properties were observed.
- Executive summary:
In a guinea pig maximisation test method the potential of Elintaal F for skin sensitisation was tested similar to OECD 406 guideline.
The intradermal injections (5% test substance concentration) given in the induction phase resulted in slight erythema, slight edema and abscesses. The 10% concentration in vaseline induced neither erythema nor edema upon topical application in the induction phase.
In the first challenge, the 10% concentration provoked very slight erythema in 3 animals in the test group. The control animals showed no reaction. The 5% concentration in the rechallenge showed no reaction in the test animals or in the control animals.
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