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EC number: 947-718-9 | 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:
- 21 May - 27 July 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- only 5 instead of 10 animals in the test group
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No. 1907/2006. In accordance with the same Regulation, the data were included to avoid unnecessary testing.
Test material
- Reference substance name:
- Isooctadecanoic acid, ester with oxybis[propanediol]
- EC Number:
- 277-361-8
- EC Name:
- Isooctadecanoic acid, ester with oxybis[propanediol]
- Cas Number:
- 73296-86-3
- Molecular formula:
- C24H50O7
- IUPAC Name:
- 16-methylheptadecanoic acid; 3-(2,3-dihydroxypropoxy)propane-1,2-diol
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- Aai: (HA) Outbred
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Microbiological status of animals, when known: viral antibody free
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 360 - 450 g
- Housing: stainless steel cages, not further specified
- Diet: Lab Diet Certified Guinea Pig Diet #5026, ad libitum
- Water: tap water, ad libitum
- Acclimation period: min. 7 days
- Indication of any skin lesions: animals were carefully checked prior to test initiation for respiratory or intestinal disease, skin eruptions, mucosal membrane irritation, postural difficulties and general condition
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6 - 29.4
- Humidity (%): 30 - 70
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 / 12
- IN-LIFE DATES: 22 May - 22 June 2002
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: TiterMax/distilled water (1:1)
- Concentration / amount:
- 100% and 5%
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- screening study with test group: 3 male, 2 females
test group: 3 males, 2 females
negative control group for test item: 2 males, 3 females
screening study with positive control group: 2 males, 3 females
positive control group: 3 males, 2 females
negative control group for positive control item: 2 males, 3 females - Details on study design:
- RANGE FINDING TESTS:
A. INTRADERMAL SCREEN:
It was determined if the test item, injected intradermally, causes local necrosis or ulceration or any systemic toxicity. Skin corrosion potential was screened using 1 guinea pig. 3 injections of 0.1 mL volume were made.
injection 1: 5% in a 50/50 emulsion of TiterMax and distilled water
injection 2: 100%
injection 3: 50% in distilled water
No necrosis or ulceration was noted at 24 and/or 48 h after the injections.
B. TOPICAL SCREEN:
The highest non-irritating concentration (HNIC) for a topical application of the test item was also determined. The test item was diluted in distilled water. 4 animals (2 males and 2 femals) were prepared by close-clipping the dorsal area of their trunks. During all shaving procedures, care was taken to avoid abrading the shaved skin. On the same day, 4 sites on each animal were treated with the test item at decreasing concentrations: 100%, 50%, 25% and 10%. 0.4 mL of the test item were applied to each site. The animals were wrapped after dosing with a piece of 3 inch elastic tape. The wraps remained in place for 24 h before they were removed. Any excess test item was wiped away with ethanol 45 h after application. The test sites were scored 3 h after the ethanol wipe and again 24 h later. The test article elicited no irritation at 100% and therefore that concentration was chosen for the challenge phase.
MAIN STUDY
A. INTRADERMAL INDUCTION EXPOSURE
A 4x6 cm section of the shoulder area of each animal in the test groups was shaved, as detailed previously. 3 pairs of subcutaneous injections (0.1 mL volume) were made in 2 rows; 1 row on each side of the midline. The injection sites were just within the boundaries of the 2x4 cm patch, which was applied 1 week later in the course of the topical induction procedure.
- No. of exposures: 1 (intradermal injection)
- Exposure period: single injection (intradermal)
- Test groups:
Intradermal (3 pairs of injections)
1st pair: TiterMax/water emulsion (1:1), without the test item
2nd pair: 100% test item
3rd pair: 5% test item in TiterMax/distilled water (1:1)
- Control group: not treated
- Site: shoulder region
- Frequency of applications: on first day of induction
B. TOPICAL INDUCTION EXPOSURE
6 days after the injections were made the sites were again shaved. Sodium lauryl sulfate (SLS) at 10% in petrolatum, was then applied to the induction site of each animal to enhance a possible sensitization reaction by provoking a mild inflammatory reaction. 7 days after the injections were made, the test item at 100% was applied to the injection sites. 0.5 mL of the test item was spread onto a 2x4 cm patch of filter paper. The filter paper was placed on the test site and covered with a piece of tape. Further tapes were then wound around the test site of the animal. The wraps and patches were removed after 48 h.
- No. of exposures: 1 (epicutaneous)
- Exposure period: 48 h
- Test groups: 100% test item after treatment with sodium lauryl sulfate (SLS) (10% in petrolatum) to provoke skin irritation
- Control group: not treated
- Site: shoulder region
- Frequency of applications: 7 days after intradermal injection
- Concentrations: 100%
B. CHALLENGE EXPOSURE
2 weeks after the topical induction applications, the challenge application was made. Prior to dosing, a 5x5 cm area of the flank of each guinea pig, in the test group as well as the negative control group was shaved. 0.4 mL of the undiluted (100%) test item was applied to each site. The animals were wrapped after dosing with a piece of 3 inch elastic tape. The wraps remained in place for 24 h. 21 h after unwrapping, any remaining test item was removed with an ethanol wipe and the test site was shaved if necessary. 3 h later, the test site was scored according to the Draize Scale. 24 and 48 h later, the sites were again scored.
- No. of exposures: 1 (epicutaneous)
- Day(s) of challenge: 2 weeks after topical induction exposure
- Exposure period: 24 h
- Test groups: test item only
- Control group: test item only
- Site: flanks
- Concentrations: 100%
- Evaluation (hr after challenge): 24, 48 and 72 - Challenge controls:
- The control group is actually a challenge control
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-dinitrobenzene
Results and discussion
- Positive control results:
- The positive control substance (1-chloro-2,4-dinitrobenzene, induction: 5% in corn oil, challenge: 0.05% in petroleum jelly) induced positive reactions in 4/5 animals (80%) in both the 1st and the 2nd readings after challenge, thus demonstrating the validity of the test.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge:100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction and challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Induction: 5% in corn oil; challenge: 0.05% in petroleum jelly
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Clinical observations:
- erythema formation
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge:100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction and challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Induction: 5% in corn oil; challenge: 0.05% in petroleum jelly
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Clinical observations:
- erythema formation
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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