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EC number: 431-540-9 | CAS number: 170573-32-7
- 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 16, 1999 to April 28, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The purpose of this skin sensitization study was to assess the allergenic potential of the test substance when administered to the skin of albino guinea pigs. This study should provide a rational basis for risk assessment of the sensitizing potential of the test article in man. The sensitivity and reliability of the experimental technique employed was assessed by use of 2-mercaptobenzothiazole which is recommended by OECD 406 Guidelines and is known to have moderate skin sensitization properties in the guinea pig strain.
Test material
- Reference substance name:
- -
- EC Number:
- 431-540-9
- EC Name:
- -
- Cas Number:
- 170573-32-7
- Molecular formula:
- C21H43NO2
- IUPAC Name:
- N-(2-hydroxypropyl)-2,2,5,8,11,11-hexamethyldodecanamide
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Remarks:
- Ibm: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted)
- Sex:
- male
- Details on test animals and environmental conditions:
- Source: RCC Ltd Biotechnology & Animal Breeding Division CH-4414 Füllinsdorf / Switzerland
Age when treated: 4-6 weeks
Weight: 314-405 g
Temperature: 20-28 °C and relative humidity: 32-84%
Light period: 12 hour light/dark cycle
Diet: pelleted Standard Nafag Ecosan 845 25W4,ad libitum
Water: community tap water, ad libitum
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Remarks:
- bi-distilled
- Concentration / amount:
- 1) 1:1 (v/v) mixture of Freunds Complete Adjuvant and physiological saline.
2) The test substance, at 5% in bi-distilled water.
3) The test substance at 5% in a 1:1 (v/v) mixture of Freunds Complete Adjuvant and physiological saline.
(control animals: without the test substance) - Day(s)/duration:
- Dermal reactions were assessed 24 hours later
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- bi-distilled
- Concentration / amount:
- Four intradermal injections (0.1 mL/site) of a 1:1 (v/v) mixture of Freund’s Complete
Adjuvant/physiological saline were made into the shaved neck of two guinea pigs. One week later both flanks of each of the guinea pigs were clipped and shaved just prior to the application. Thereafter 4 patches of filter paper (3 x 3 cm) were saturated with the test substance at A = 100%, B = 75%, C = 50% and D = 25% and applied to the clipped and shaved flanks. The volume of test substance preparation applied was approximately 0.3 mL. The patches were covered by a strip of aluminum foil and firmly secured by elastic plaster wrapped around the trunk and covered with impervious adhesive tape. - Day(s)/duration:
- 24h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- bi-distilled
- Concentration / amount:
- The test and control guinea pigs were challenged two weeks after the epidermal induction application. Hair was clipped and shaved from a 5 x 5 cm area on the left and right flank of each guinea pig just prior to the application. Two patches (3 x 3 cm) of filter paper were saturated with the test substance at the highest non-irritating concentration of 1% (left flank) and the vehicle only (bi-distilled water applied to the right flank) using the same method as for the epidermal application. The volume of test substance preparation and vehicle applied was approximately 0.2 mL. The dressings were left in place for 24 hours. Twenty-one hours after removal of the dressing the test sites treated with the test substance were depilated as described in the epidermal pretest.
The reaction sites were assessed approximately 24 and 48 hours after removal of the bandage for erythema and oedema according to the method of Magnusson and Kligman. - Day(s)/duration:
- 24h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 (test) and 5 (control) male albino guinea pigs
- Details on study design:
- In order to assess the cutaneous allergenic potential of the test substance, the maximization-test was performed in 15 (10 test and 5 control) male albino guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 96/54/EEC, B.6. The intradermal induction of sensitization in the test group was performed with a 5% dilution of the test substance in bi-distilled water and in an emulsion of Freunds Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted under occlusion with the undiluted test substance one week after the intradermal induction. The animals of the control group were intradermally induced with bi-distilled water and FCA/physiological saline and epidermally induced with bi-distilled water under occlusion. Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test substance at 1% in bi-distilled water and bi-distilled water alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.
- Challenge controls:
- Negative control: vehicle alone
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
Results and discussion
- Positive control results:
- 2-mercaptobenzothiazole:
90% (at the 24-hour reading) and 100% (at the 48-hour reading) of the animals of the test group were observed with very slight to moderate/severe erythematous reactions after treatment with a non-irritant test substance concentration of 10% in mineral oil. No skin reactions were observed in the control group. A response of at least 30% positive animals is considered positive “R43”: may Cause sensitization by skin contact according to the “Commission Directive 96/54/EEC, July 30, 1996 adapting to technical progress for the 22nd time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances”. Therefore, the positive control substance applied at a concentration of 10% in mineral oil was considered to be an extreme sensitizer when used under the described test conditions.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse effects
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse effects
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10% in mineral oil
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- very slight to moderate/severe erythematous reactions
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10% in mineral oil
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- very slight to moderate/severe erythematous reactions
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Skin effects after intradermal induction (on test day 1):
The expected and common findings were observed in the control and test group after the different applications using FCA intradermally and consisted of erythema, oedema, necrotizing dermatitis, encrustation and exfoliation of encrustation.
Skin effects after epidermal induction (on test day 8):
Control group: No erythematous or oedematous reaction was observed in the animals treated with bi-distilled water only.
Test group: Discrete/patchy erythema was observed in all surviving test animals at the 24-hour reading after treatment with the undiluted test substance. One animal still showed the same skin effect at the 48-hour reading.
Skin effects after the challenge (on test day 22):
Control group: No skin reactions were observed in the animals when treated with either bi-distilled water only or when treated with the test substance at 1% in bi-distilled water.
Test group: No skin reactions were observed in the animals when treated with either bi-distilled water only or when treated with the test substance at 1% in bi-distilled water.
Viability/mortality/macroscopic findings:
One animal of the test group was found dead on test day 10 (i.e., day of removal of the dressing in the epidermal induction phase). At necropsy, no findings were noted. The cause of death could not be established. The death was considered to be spontaneous and treatment-unrelated.
Clinical signs, systemic:
No signs of systemic toxicity were observed in the animals.
Body weights:
One animal of the control group showed a loss of body weight (4.6%) between the treatment start and the end of the study. The body weight of the other animals was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditons, the test substance was not considered to be a skin sensitizer.
- Executive summary:
A study was conducted to evaluate the skin sensitisation potential of the test substance, isoC18 MIPA (94.1% active), according to OECD Guideline 406 and EU Method B.6, in compliance with GLP. The test was performed in 15 (10 test and 5 control) male albino guinea pigs. The intradermal induction of sensitization was performed with a 5% dilution of the test substance in bi-distilled water and in an emulsion of Freunds Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted under occlusion with the undiluted test substance one week later. The animals of the control group were intradermally induced with bi-distilled water and FCA/physiological saline and epidermally induced with bi-distilled water under occlusion. Two weeks after epidermal induction, the control and test animals were challenged by epidermal application of the test substance at 1% in bi-distilled water and bi-distilled water alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 h after removal of the dressing. The expected and common findings were observed in the control and test group after the different applications using FCA intradermally (on test day 1) and consisted of erythema, oedema, necrotizing dermatitis, encrustation and exfoliation of encrustation. After epidermal induction (Day 8), no erythematous or oedematous reaction was observed in the animals treated with bi-distilled water only (control group). Discrete/patchy erythema was observed in all surviving test animals (treated group) at the 24 h reading after treatment with the undiluted test substance. One animal still showed the same skin effect at the 48 h reading. Following challenge (Day 22), no skin reactions were observed in the animals when treated with either bi-distilled water only (control group) or when treated with the test substance at 1% in bi-distilled water (treated group). Under the study conditons, the test substance was not considered to be a skin sensitizer (Arcelin, 1999).
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