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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Berolamine AA15. pre-GLP, and not according to standard testing method.
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:
- other: FDA - Fed.Reg. 37(244),27635, 1972
- Principles of method if other than guideline:
- FDA
Six rabbits, exposed with 0.5 ml of test susbstance and control (10% aqueous SLS) on intact clipped skin, and abraded skin. Under 1 inch square patched, left under occlusion for 24 hours. Scoring immediately after exposure and 48 hours later (72 hour reading). Scoring according FDA scoring system. - GLP compliance:
- no
- Remarks:
- Pre-GLP; signed authentication form present
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Leslie Moore Ltd
- Age at study initiation: not indicated
- Weight at study initiation: Between 2 and 3 kg
- Housing: 1 animal/cage
- Diet (e.g. ad libitum): Spratts Rabbit Diet (Spillers) - ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS: Not indicated
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped, partially abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): applied unchanged
CONTROL: Aqueous sodium lauryl sulphate (SLS)
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): applied unchanged: 10% - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours from start of exposure
- Number of animals:
- 6 animals, 4 sites per animal:
- Test substance and control
- Clipped and abraded - Details on study design:
- TEST SITE
- Area of exposure: Under seperate 1" square patches of chromatography paper
- % coverage: not indicated
- Type of wrap if used: overlapping patch of impermeable plastic adheasive tape (Blenderm). The whole area was bound by Sleek occlusive tape wrapped round the entire trunk of the animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The site was 'gently cleaned'
- Time after start of exposure: After 24 hours
SCORING SYSTEM: FAD scoring system
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 and 72 hour
- Score:
- 2.6
- Max. score:
- 8
- Reversibility:
- no data
- Remarks on result:
- other: PII 10% SLS = 3.6
Any other information on results incl. tables
Primary Skin Irritation in Rabbits: Mean scores and primary irritation scores
Reading time (h) | Reaction score | ||
A | B | ||
Erythema & Eschar Formation | |||
Intact skin | 24 | 1,17 | 1,83 |
Intact skin | 72 | 0,92 | 1,00 |
Abraded skin | 24 | 1,83 | 2,33 |
Abraded skin | 27 | 1,33 | 1,83 |
Sub total | 5,25 | 6,99 | |
Oedema formation | |||
Intact skin | 24 | 1,00 | 1,83 |
Intact skin | 72 | 0,92 | 1,17 |
Abraded skin | 24 | 2,00 | 2,33 |
Abraded skin | 27 | 1,33 | 2,17 |
Sub total | 5,25 | 7,50 | |
Total | 10,50 | 14,49 | |
Primary Irritation Score | 2,6 | 3,6 |
A = Berolamine AA15
B = 10% SLS
The reaction score is the average value of results from the 6 test animals. The primary irritation score calculation: Values for erythema and eschar formation at 24 h and 72 h (4 values) are added to the values for oedema at 24 h and 72 h ( 4 values) and the resulting figure is divided by 4.
The primary irritation score of Berolamine AA15 calculated for intact skin and abraded skin seperately:
Intact skin: 2.0
Abraded skin: 3.2
Same for SLS:
Intact skin: 2.9
Abraded skin: 4.3
Scoring:
Value - Erythema and Eschar Formation
0 - No erythema
1 - Very slight erythema (barely perceptible, edges of area not well defined)
2 - Slight erythema (pale red in color and edges definable)
3 - Moderate to severe erythema (definite red in color and area well defined)
4 - Severe erythema (beet or crimson red) to slight eschar formation (injuries in depth)
Edema Formation:
0 - No edema
1 - Very slight edema (barely perceptible, edges of area not well defined)
2 - Slight edema (edges of area well defined by definite raising)
3 - Severe edema (raised more than 1 mrn and extending beyond area of exposure)
4 - Moderate edema (raised approximately 1 mm)
Applicant's summary and conclusion
- Conclusions:
- Not corrosive, but possibly itrritating. Not suitable for EU classification.
- Executive summary:
Berolamine AA15 was tested for primary irritation according to FDA - Fed.Reg. 37(244),27635, 1972. The substance was applied to the intact and abraded skin of 6 rabbits following 24 hour exposure from 0.5 ml on 1 square inch chromatography paper under occlusion. Scoring for erythema and eschar formation and oedema formation were performed on 24 and 72 hours after the start of the exposure. The primary irritation index resulted to 2.0 for the intact skin following FDA scoring system.
Based on the calculated primary irritation index, the susbstance would be classified as moderate skin irritant.
The iritation and oedema scoring for the intact skin was on average about 1 for each at 24 hour observation period as well as at 72 hour observation periode. As such, the level of rritation was less than following exposure to 10% aqueous sodium lauryl sulphate.
Although no evaluation according OECD/EU guideline, the exposure of 0.5 mL under occlusion for 24 hours, is expected to result to more severe dermal reactions compared to OECD guideline exposures of 0.5 ml for 4 hours under semi-occlusive conditions.
Results from this study indicate that the substance is not corrosive, but possibly irritating.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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