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EC number: 701-328-3 | 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 1990-08-14 to 1990-11-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted in compliance with GLP principle and Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study had been conducted in 1990, before development of the LLNA method
Test material
- Reference substance name:
- Alcohols, C13-15 (odd numbered, branched and linear)
- Molecular formula:
- C13H28O and C15H32O
- IUPAC Name:
- Alcohols, C13-15 (odd numbered, branched and linear)
- Reference substance name:
- Alcohols, C13, branched glycidyl ethers
- Molecular formula:
- C16H32O2
- IUPAC Name:
- Alcohols, C13, branched glycidyl ethers
- Reference substance name:
- [(tridecyloxy)methyl]oxirane
- EC Number:
- 276-765-1
- EC Name:
- [(tridecyloxy)methyl]oxirane
- Cas Number:
- 72689-40-8
- Molecular formula:
- C16H32O2
- IUPAC Name:
- 2-[(tridecyloxy)methyl]oxirane
- Reference substance name:
- Alcohols, C15, branched glycidyl ethers
- Molecular formula:
- C18H36O2
- IUPAC Name:
- Alcohols, C15, branched glycidyl ethers
- Reference substance name:
- [(pentadecyloxy)methyl]oxirane
- EC Number:
- 302-058-5
- EC Name:
- [(pentadecyloxy)methyl]oxirane
- Cas Number:
- 94088-56-9
- Molecular formula:
- C18H36O2
- IUPAC Name:
- 2-[(pentadecyloxy)methyl]oxirane
- Reference substance name:
- secondary reaction products of Oxirane, mono{[C13-15 (odd numbered, linear and branched)-alkyloxy)methyl] derivs.
- Molecular formula:
- UVCB, not applicable
- IUPAC Name:
- secondary reaction products of Oxirane, mono{[C13-15 (odd numbered, linear and branched)-alkyloxy)methyl] derivs.
- Reference substance name:
- unknown constituents
- IUPAC Name:
- unknown constituents
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
- Specific details on test material used for the study:
- - Name of test material: ALKYL (C13-C15) - GLYCIDYLETHER
- Physical state: Liquid
- Lot/batch No.: DC 1295.3
- Storage condition of test material: At room temperature, in the dark.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL Bio1ogica1 Research Laboratories Ltd. Wölferstrasse 4 CH - 4414 Füllinsdorf
- Age at study initiation: males (7 weeks); females (8 weeks).
- Weight at study initiation: males (332 - 358 g); females (323 - 342 g)
- Housing: Individually in Makrolon type-3 cages with standard softwood bedding.
- Diet: Pelleted standard Kliba 342 ad libitum
- Water: Community tap water from Itingin ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3 °C
- Humidity (%): 40 - 70%
- Air changes (per hr): Air-conditioned with 10 - 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Oleum arachidis
- Concentration / amount:
- Intradermal injections: 5% with oleum arachidis
Epidermal applications: 75% in vaseline
Challenge: 25% in vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Oleum arachidis
- Concentration / amount:
- Intradermal injections: 5% with oleum arachidis
Epidermal applications: 75% in vaseline
Challenge: 25% in vaseline
- No. of animals per dose:
- Control group: 5 males and 5 females
Test group: 10 males and 10 females - Details on study design:
- RANGE FINDING TESTS:
Intradermal injections: Intradermal injections (0.1 ml/site) were made into the clipped flank of two guinea-pigs at concentrations of 5, 3 and 1% of the test article in oleum arachidis. The resulting dermal reactions were assessed 24 hours later.
Epidermal applications: Patches of filter paper (2 x 2 cm) were saturated with the undiluted test article and with concentrations of 75%, 50% and 25% of the test article in vaseline and applied to the clipped and shaved flanks of each of four guinea-pigs. The patches were covered by a strip of aluminum foil and firmly secured by elastic plaster wrapped around trunk and covered with impervious adhesive tape. The dressings were removed after an exposure period of 24 hours and the reaction sites were assessed.
MAIN STUDY:
Induction
Intradermal injections: An area of dorsal skin from the scapular region (approximately 6 x 8 cm) was clipped from the hair. Three pairs of intradermal injections ( 0.1 ml/site) were made at the border of a 4 x 6 cm area in the clipped region as follows:
Test group:
1) Freund’s complete adjuvant 50:50 with physiological saline.
2) The test article, dilute to 5% with oleum arachidis.
3) The test article at the concentration used in (2), emulsified in a 50:50 mixture of Freund’s complete adjuvant and the vehicle used in (2).
Control group:
1) Freund’s complete adjuvant 50:50 with physiological saline.
2) Vehicle used in (2) for test group.
3) Freund’s complete adjuvant 50:50 with physiological saline.
Epidermal applications: One week after the injections, the scapular area (approximately 6 × 8 cm) was again clipped and shaved free of hair. A 2 × 4 cm patch of filter paper was saturated with the test article (75% in vaseline) and placed over the injection sites of the test animals. The patch was covered by aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The dressings were left in place for approximately 48 hours.
The guinea-pigs of the control group were treated as described above with the omission of test article.
Reaction sites were assessed for erythema and edema 24 and 48 hours after removal of the dressing.
Challenge:
The test and control guinea-pigs were challenged two weeks after the epidermal induction application.
Hair was clipped and shaved from a 5 × 5 cm area on the left and right flank of each guinea-pig. Two patches (2 × 2 cm) of filter paper were saturated with a) non-irritant concentration (25% in Vaseline) of the test article and b) with the vehicle only and applied to the (a) left flank and (b) right flank using the same method as for the epidermal application.
The dressings were removed approximately 24 hours later. The sites were assessed for erythema and edema 24 and 48 hours after removal of the dressing.
The control guinea-pigs were treated in the same way as described as above.
Re-challenge:
A second challenge was performed two weeks after the first challenge. The treatment procedure for the animals of the test group was similar as described for the first challenge with the exception that the flanks of the guinea-pigs and the vehicle used for the test article dilution were changed (a – vehicle; b- 25% test article in oleum arachides).
The control animals were treated with the vehicle alone on the left flank. - Positive control substance(s):
- yes
- Remarks:
- Formaldehydloesung (HCHO)
Results and discussion
- Positive control results:
- HCHO possess an strong skin sensitizing potential in the guinea pig.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1 ml/site
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1 ml/site. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1 ml/site
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1 ml/site. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% in vaseline
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- slight to moderate erythema/Edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% in vaseline. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: slight to moderate erythema/Edema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% in vaseline
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- slight to moderate erythema/Edema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% in vaseline. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: slight to moderate erythema/Edema.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1ml/site
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1ml/site. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% in oleum arachides
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- slight to moderate erythema/Edema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25% in oleum arachides. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: slight to moderate erythema/Edema.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% in oleum arachides
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- slight to moderate erythema/Edema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25% in oleum arachides. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: slight to moderate erythema/Edema.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 20% HCHO in water
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Subproject 270066, Appendix E in test report
Any other information on results incl. tables
Sensitizing effects
Mortality / Viability No death occurred during the study. Symptoms, systemic No systemic symptoms were observed in the animals. Body weights The body weight gain of the animals was not affected adversely during the study. |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- This study was conducted according to Maximization test and the result indicated that test substance may cause skin sensitization to guinea pigs.
- Executive summary:
This study was conducted to evaluate the potential of the test article to induce hypersensitivity in guinea pigs using the Maximization test.
For the intradermal induction phase of the study, three pairs of intradermal injections were made at the scapular skin of test group and control group as above mentioned method in which the test article was diluted to 5% with oleum arachidis. One week later, the epidermal induction started. Scapular skin was clipped and shaved free of hair. A patch was saturated with 75% the test article in vaseline and placed over the injection sites of test group and only vaseline was placed on the skin of control group.
The test and control group were challenged two weeks after the epidermal induction application. Two patches were saturated with a) 25% in vaseline of the test article and b) with the vehicle only and applied to the left flank and right flank using the same method as for the epidermal application.
A second challenge was performed two weeks after the first challenge. The treatment procedure was similar as described for the first challenge with the exception that vehicle was applied to the left flank and 25% test article in oleum arachides was applied to the right flank.
The challenge site was evaluated 24 and 48 hours after removal of the patch. The reactions were scored on the basis of the Draize score.
The test result of the first challenge in test group showed positive erythema reactions at 24h and 48h when treated with 25% test article in vaseline. The test result of the second challenge in test group showed positive erythema reactions at 24h and 48h when treated with 25% test article dilution in oleum arachides.
Based on the study results, it is concluded that test substance can be classified as skin sensitizer (category 1) in accordance with CLP (Regulation EC No. 1272/2008).
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