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EC number: 939-624-1 | 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:
- 01 October 1992 - 02 November 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented study performed according to a method similar to OECD Guideline 406 with some minor deviations: the vehicle choice was not justified, no precise details were given on used patch materials
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- the vehicle choice was not justified, no precise details were given on used patch materials
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- reaction mass of 1-chloro-3-[(Z)-octadec-9-en-1-yloxy]propan-2-ol and alpha-(Z)-octadec-9-en-1-yl-omega-hydroxy-di[oxy[(chloromethyl)-1,2-ethanediyl]] and alpha-(Z)-octadec-9-en-1-yl-omega-hydroxy-tri[oxy[(chloromethyl)-1,2-ethanediyl]]
- Cas Number:
- 108726-95-0
- Molecular formula:
- C21H41O2Cl C24H46O3Cl2 C27H51O4Cl3
- IUPAC Name:
- reaction mass of 1-chloro-3-[(Z)-octadec-9-en-1-yloxy]propan-2-ol and alpha-(Z)-octadec-9-en-1-yl-omega-hydroxy-di[oxy[(chloromethyl)-1,2-ethanediyl]] and alpha-(Z)-octadec-9-en-1-yl-omega-hydroxy-tri[oxy[(chloromethyl)-1,2-ethanediyl]]
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: brown liquid
- Lot/batch No.: op600
- Date received: 29 May 1992
- Storage condition of test material: at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lebeau, 78950 Gambais, France
- Weight at study initiation: 346 +/- 19g ( males) and 331 +/- 20g (females)
- Housing: individually in polypropylene cages (48*27*20 cm) covered by sawdust (SICSA, Alfortville, France)
- Diet: complete pelleted diet "Cobayes entretien référence 106" (UAR, Villemoisson-sur-Orge, France), ad libitum
- Water: Water filtered on a 22 µm membrane (Millipore, Vélizy, France)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 06 October 1992 To: 02 November 2012
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Remarks:
- Lot No 6909 (Gifrer, Decines, France)
- Concentration / amount:
- RANGE FINDING TEST:
- Intradermal induction exposure: 1, 10, 25 and 50% w/w in paraffin oil
- Topical induction exposure: 75% in paraffin oil and undiluted
MAIN TEST:
- Intradermal induction exposure: 50 % w/w in paraffin oil; mixture of 50% w/w in paraffin oil in Freund's Complete Adjuvant (FCA) plus distilled water in the ratio 1:1
- Topical induction exposure: undiluted test item
- Topical challenge exposure: undiluted test item
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Remarks:
- Lot No 6909 (Gifrer, Decines, France)
- Concentration / amount:
- RANGE FINDING TEST:
- Intradermal induction exposure: 1, 10, 25 and 50% w/w in paraffin oil
- Topical induction exposure: 75% in paraffin oil and undiluted
MAIN TEST:
- Intradermal induction exposure: 50 % w/w in paraffin oil; mixture of 50% w/w in paraffin oil in Freund's Complete Adjuvant (FCA) plus distilled water in the ratio 1:1
- Topical induction exposure: undiluted test item
- Topical challenge exposure: undiluted test item
- No. of animals per dose:
- 10 animals/sex in the treated group; 5 animals/sex in the control group
- Details on study design:
- RANGE FINDING TESTS:
- Intradermal induction exposure: different concentrations were tested (1, 10, 25 and 50%) in order to select one that does not cause ulceration or necrosis.
MAIN STUDY
A. INDUCTION EXPOSURE: INTRADERMAL
- No. of exposures: One
- Day of induction: Day 1
- Test groups: 3 intradermally injection of 0.1 mL each of:
¤ a mixture of 1:1 (v/v) of FCA and 0.9% NaCl,
¤ test material diluted to 50% in paraffin oil,
¤ a mixture of 1:1 (V/V) of test material diluted to 50 % in paraffin oil and a mixture of 1:1 (v/v) of FCA and 0.9% NaCl
- Control group: 3 intradermally injection of 0.1 mL each of:
¤ a mixture of 1:1 (v/v) of FCA and 0.9% NaCl,
¤ paraffin oil,
¤ 50 % of paraffin oil in a mixture of 1:1 (v/v) of FCA and distilled water
- Site: Both sides of the spinal column, at the scapular level
Before the topical induction exposure, a local irritation was created on Day 7 by applying dermallyt 0.5 mL of sodium lauryl sulfate 10% (v/v) in paraffin oil in the scapular area.
B. INDUCTION EXPOSURE: TOPICAL
- No. of exposures: One
- Day of induction: Day 8
- Exposure period: 48 hr
- Test group: 0.5 mL of the undiluted test material was applied under an occlusive patch (4*2 cm)
- Control group: 0.5 mL of paraffin oil under an occlusive patch (4*2 cm)
- Site: Same as intradermal injection area
- Frequency of applications: Single application
C. CHALLENGE EXPOSURE: TOPICAL
- No. of exposures: One
- Day(s) of challenge: Day 22
- Exposure period: 24 hr
- Test and control groups: 0.5 mL of:
¤ the undiluted test material under an occlusive patch (2*2 cm) on the right flank
¤ paraffin oil under an occlusive patch (2*2 cm) on the left flank
- Site: dorso-lumbar region
- Evaluation (hr after challenge): 24 and 48 hr
OTHER:
- Animals were observed once daily for mortality and clinical signs
- Body weight: animals were weighed on Day -1, 1, 8, 15 and 25
- Pathology: On completion of the observation period, all animals were sacrificed by C02 asphyxiation. No macroscopic post-mortem examination was performed in any animals. For all animals, skin samples of the challenged application sites were preserved in 10 % buffered formalin. No microscopic examination was performed - Challenge controls:
- A dry gauze (2 x 2 cm) moistened with 0.5 mL of undiluted test material applied on the right flank of the dorso-lumbar region of each animal via an occlusive patch.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- N/A
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% (w/w) in paraffin oil
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% (w/w) in paraffin oil. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% (w/w) in paraffin oil
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- Dryness of the skin in 5 animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (w/w) in paraffin oil. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: Dryness of the skin in 5 animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: None.
Any other information on results incl. tables
Table 7.4.1/2 Main test results
Group |
Sex |
Erythema score |
Hours after challenge |
|||
24 hr |
48 hr |
|||||
LF |
RF |
LF |
RF |
|||
Control |
Males |
0 1 |
- - |
5/5 0 |
- - |
2/5 3/5 |
Females |
0 1 2 |
- - - |
5/5 0 0 |
- - - |
1/5 1/5 3/5 |
|
Treated group |
Males |
0 1 |
10/10 0 |
9/10 1/10 |
10/10 0 |
8/10 2/10 |
Females |
0 1 2 |
10/10 0 0 |
8/10 2/10 0 |
10/10 0 0 |
9/10 0 1/10 |
LF: left flank RF: right flank
- : untreated flank
Cutaneous reactions:
- Necrosis was observed on the site of intradermal injection in animals treated with the test item on Day 10.
- A very slight erythema (grade 1) was observed on the right flank (treated with the test item) in 7/10 animals in the control group at the 48 hr reading. No dermal reactions were observed in the other control animals.
- In the treated group, a very slight erythema (grade 1) was observed on the right flank (treated with the test item) in 3/20 animals at the 24 hr reading. A very slight and slight erythema were observed on the right flank (treated with the test item) in 2/20 and 1/20 animals, respectively, at the 48 hr reading.
- As the dermal reactions observed on the right flank (treated with the test item) of the test item-treated animals were of the same severity as those recorded in the control animals, they were not attributed to delayed contact hypersensitivity.
Others:
- No unscheduled deaths occurred during the study.
- No clinical signs indicative of systemic toxicity were observed in any animals.
- Body weight of the animals was unaffected by the test item treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these test conditions, the test material is not classified as skin sensitiser according to the Annex VI to the Directive 67/548/EEC and to the CLP Regulation (EC) N° (1272 -2008).
- Executive summary:
In a non-GLP Magnusson & Kligman maximisation study (GPMT) performed according to a method equivalent to OECD Guideline 406, 20 Dunkin Hartley guinea pigs were induced with three pairs of intradermal injections (0.1 mL each) of FCA in 0.9% NaCl (1:1), the test material 50 % (w/w) in paraffin oil, and the test material 50 % (w/w) in paraffin oil in a 1:1 preparation of FCA in 0.9% NaCl, on Day 1 on three different sites on each side of the spinal column at the scapular level. The control group of 10 animals (5/sex) was intradermally induced with 0.1 mL of FCA in 0.9% NaCl (1:1), paraffin oil and paraffin oil in a preparation of FCA in 0.9% NaCl (1:1). After 7 days, 0.5 mL of sodium lauryl sulphate was applied to the skin to induce an inflammatory reaction. On Day 8, the same area was topically induced with undiluted test material under an occlusive patch for 48 hr for the treated group, and with paraffin oil only in the control group. After a 11 day resting period, a challenge occlusive patch of undiluted test material were applied for 48 hr to the dorso-lumbar region of each animal.
No mortality and no clinical signs of systemic toxicity were observed during the study. A very slight erythema (grade 1) was observed on the right flank (treated with the test item) in 7/10 animals in the control group at the 48 hr reading. In the treated group, a very slight erythema (grade 1) was observed on the right flank (treated with the test item) in 3/20 animals at the 24 hr reading. A very slight and slight erythema were observed on the right flank (treated with the test item) in 2/20 and 1/20 animals, respectively, at the 48 hr reading.
As the dermal reactions observed on the right flank (treated with the test item) of the test item-treated animals were of the same severity as those recorded in the control animals, they were not attributed to delayed contact hypersensitivity.
Under these test conditions, the test material is not classified as skin sensitiser according to the Annex VI to the Directive 67/548/EEC and to the CLP Regulation (EC) N° (1272 -2008).
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