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EC number: 295-714-4 | CAS number: 92128-22-8
- 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:
- June to July 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- - the second induction on Day 7 was performed by intradermal injection; two challenges were performed on Day 21 and Day 35 by topical application under occlusive conditions for 6 hours each
- 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 guinea pig maximisation test (GPMT) was an adequate in vivo skin sensitisation test at the time of performance in 1992.
Test material
- Reference substance name:
- Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides
- EC Number:
- 295-714-4
- EC Name:
- Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides
- Cas Number:
- 92128-22-8
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Reaction products of tall-oil fatty acids and (3-aminopropyl)dimethylamine
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Bor: DHPW
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann GmbH (Borchen, Germany)
- Age at study initiation: 5 - 8 weeks
- Weight at study initiation: 320 - 404 g
- Housing: 5 animals per cage (Makrolon cages type IV) on low dust wood granulate bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 1.5
- Humidity (%): 40 - 70
- Air changes (per hr): approx. 12 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 1st induction: 2.5 %
2nd induction: 3 %
1st and 2nd challenge: 0.5 % and 1.0 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 1st induction: 2.5 %
2nd induction: 3 %
1st and 2nd challenge: 0.5 % and 1.0 %
- No. of animals per dose:
- 20 (test groups); 10 (control groups)
- Details on study design:
- INTRADERMAL INDUCTION: three pairs of intradermal injections were made at the clipped skin site of each animal. A volume of 0.1 ml was injected. Animals of the test group were treated at the following injection sites:
cranial - emulsified Freund’s complete adjuvant 1:1 with physiol. NaCl
medial - 2.5 % test item in propylene glycol
caudal - 2.5 % test item in propylene glycol and emulsified Freund’s complete aduvant 1:1
Animals of the control group were treated in the same manner excepted that the test item was replaced by the vehicle alone.
TOPICAL INDUCTION: treatment group: 0.5 ml of 3 % test item in propylene glycol; control group: 0.5 ml propylene glycol
CHALLENGE: 3 weeks after the first induction phase all animals were prepared for challenge by clipping the flanks and backs free of hair. Patches of gauze coated with 5 ml aliquots of the test item at 1 and 0.5 % concentrations were placed alternating cranial or caudal of each animal. The treated sites were covered with a strip of aluminium foil and elastic adhesive bandage. After a contact period of 24 hours patches were removed. The treated sites were examined approximately 48 and 72 hours after patch removal. - Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 % test substance formulation
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 % test substance formulation. No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1 % test substance formulation
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1 % test substance formulation. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 % test substance formulation
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 % test substance formulation. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 1 % test substance formulation
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 1 % test substance formulation. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 % test substance formulation
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 % test substance formulation. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5 % test substance formulation
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5 % test substance formulation. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 % test substance formulation
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 % test substance formulation. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.5 % test substance formulation
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.5 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
None of the animals in the test groups reacted to the control patch moistened with the vehicle.
After challenge treatment skin redness in 95 % of the animals (grade 1 to 3) after 1 % test item and in 55 % of the animals (grade 1 to 2) after 0.5 % test item were observed. Skin reactions in the control groups were recorded in 40 % and 10 % of the animals after 48 hours. All positive reacting animals showed no formation of edema. 72 hours after the challenge skin reactions still persisted in most of the affected animals.
The treatment with the test substance was tolerated without clinical symptoms by all animals.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Executive summary:
In a guinea pig maximization test (GPMT) according to OECD TG 406 the test substance revealed a skin sensitizing potential at challenge concentrations of 0.5 and 1 %. 48 hours after the challenge skin reactions were observed in 95 % of the animals (grade 1 to 3) after 1 % test item and in 55 % of the animals (grade 1 to 2) after 0.5 % test item. 72 hours after the challenge skin reactions still persisted in most of the affected animals.
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