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EC number: 629-757-0 | CAS number: 1224966-15-7
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Berolamine AA15. pre-guideline, pre-GLP. No data on positive control or reliability check is given.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Remarks:
- Pre-GLP; signed authentication form present
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products
- EC Number:
- 629-757-0
- Cas Number:
- 1224966-15-7
- Molecular formula:
- UVCB, no structural formula can be set
- IUPAC Name:
- Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products
- Details on test material:
- Name: BEROLAMINE AA15, a amide/imidazoline of Berolamine 20 and a fatty acid.
Described: dark brown highly viscous liquid.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Porcellus Animals Ltd
- Age at study initiation: Not indicated
- Weight at study initiation: 300-400 g
- Housing: 5 per cage
- Diet (e.g. ad libitum): BP Nutrition FDI diet, at lib.
- Water (e.g. ad libitum): Source not specied; ad lib.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS: Not indicated
IN-LIFE DATES: From: 4 april 1979 To: 27 April 1979
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal: 1% (w/w) testsubstance in water
Topical induction: 5% (w/w) in water (slightly irritant)
Topical challenge: 2% (w/w) in water (non-irritant)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal: 1% (w/w) testsubstance in water
Topical induction: 5% (w/w) in water (slightly irritant)
Topical challenge: 2% (w/w) in water (non-irritant)
- No. of animals per dose:
- 10 animals with test substance in treatment group, 7 animals in control group.
- Details on study design:
- RANGE FINDING TESTS:
Determination of maximum non-irritant concentration in two guinea pigs that were pretreated as the induction phase. Material was tested under occlusive patch system used for topical induction in concentrations of 10%, 5%, 2% and 1.0% (w/w) in water.
Test substance was slightly irritating at 5%. A concentration of 2% in water was selected for th challenge of the test group.
MAIN STUDY
A. INDUCTION EXPOSURE
- Test group: 10 animals
1. intradermal: Two rows of three intra dermal injections on each side of the midline across the shaved scapular region.
0.1 ml Freund's Complete Adjuvant (FCA) alone
0.1 ml test agent (1% w/w) alone
0.05 ml test agent (1% w/w) emulsified with 0.05 ml FCA.
2. One topical application 6 days later:
Injection side shaved and treated with 10% lauryl sulphate for mild inflammatory response. Solution was massaged into the backs, kept unbandaged for 24 hours. Then a 2x2 cm patch (Whatman no. 3 MM filter) saturated with 5% w/w test substance, and covered by impermeable plastic adhesive tape (Blenderm). The whole area was then firmly bound by Sleek acclusive tape and dressing was left in place for 48 hours.
- Control group: 5 animals
1. intradermal: Two intra dermal injections of FCA only on each side of the midline across the shaved scapular region.
2. No topical induction
B. CHALLENGE EXPOSURE
Test group and control group:
Two weeks after topical induction, a 2% test substance solution was applied to the shave right flank of the animals using the same method as for topical induction. The patch was removed after 24 hours. The response was determined 24 hours after removal of the challenge patch.
C. RESPONSE
Any animal showing erythema at the site of challenge would be considered to have shown a positive response. - Challenge controls:
- Control group consisted of 7 animals similar to treatment group.
Controls only received FCA injections. Two animals were used for determining teh maximum test substance concentrations to be used for induction and challenge. - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No positive control or information on reliability is given.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2% w/w in water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2% w/w in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2% w/w in water
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2% w/w in water. No with. + reactions: 0.0. Total no. in groups: 5.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Substance was not senstisiting in the Guinea pig maximisation test
- Executive summary:
- Berolamine AA15 was tested according the Magnusson-Kligman Guinea pig maximisation test (similar to OECD 406). Berolamine AA15 did not elicit positive responses in the test group after challenge of the 10 guinea pigs by topical application with 2% aq. solution. From these results it is concluded that this product is a non-sensitiser in guinea pigs.
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