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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
Endpoint summary
Administrative data
Description of key information
Moderately irritating to skin and corrosive to the eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- Reason / purpose for cross-reference:
- reference to same study
- 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
- 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 - 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 - 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
- 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.
Reference
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)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Berolamine 715. Guideline, GLP principles
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- According to GLP principles (Statement SD, QA audit)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Cheshire Rabbit Farms
- Age at study initiation: no data
- Weight at study initiation: 2.5-3.0 kg
- Housing: housed individually in cages with a grid floor beneath which was a peat moss filled tray.
- Diet (e.g. ad libitum): Special Diet Services Standard Rabbit Diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 (15-19)
- Humidity (%): 46 (30-60)
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml - Duration of treatment / exposure:
- Single intillation, no flushing.
- Observation period (in vivo):
- The eyes were examined for irritation using standard illumination, unable to use fluorescein stain due to severe chemosis. The ocular reaction was recorded at one and 24 h at 24h it was decided to sacrifice the animals due to the severity of the observed effects.
- Number of animals or in vitro replicates:
- 3 male and 3 female animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
SCORING SYSTEM: as described in OECD405
TOOL USED TO ASSESS SCORE: standard illumination, unable to use fluorescein stain due to severe chemosis - Irritation parameter:
- overall irritation score
- Time point:
- other: 24h
- Score:
- > 2 - < 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- animals were killed after 24h for humane reasons
- Irritant / corrosive response data:
- Cornea
Dullness of the cornea was noted in all treated eyes 1 h and 24 h after instillation. Severe chemosis prevented the use of fluorescein stain to
assess opacity although it was noted that no obvious opacity was apparent.
Iris
Positive iridial responses (score 1-2) were noted in one treated eye at 1 h, and in all treated eyes at 24 h after instillation.
Conjunctivae
Redness
Positive redness (score 2) was noted in 5/6 treated eyes and the remaining animal showed slight redness (score 1) at 1 h post instillation. All treated eyes showed positive responses (score 2) at 24h.
Chemosis
Severe chemosis (score 3-4) was noted in all treated eyes at 1 h and 24 h.
Discharge
Moderate discharge was noted in all treated eyes at 1 h post instillation. Severe thick white discharge was noted in all treated eyes at 24 h.
No other non-ocular topical effects were noted at any time during the test. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The test substance was extremely irritant to the eye in the rabbit irritation test. The test was terminated after 24h for humane reasons.
- Executive summary:
The test substance was extremely irritant to the eyes of 3 male and 3 female rabbits after single instillation of 0.1 ml. The test was terminated after 24h for humane reasons.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
All in vivo skin irritation/corrosion studies performed on other AAI substances all indicate them to be corrosive following 4 hour exposure.
As the substances within the AAI group show the same reactive groups, show similar composition of amide, imidazoline, and some dimer structures of both, with the length of original EA amines used for production as biggest difference. Inherent reactivity and toxicity is not expected to differ much between these substances.
Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-productsdiffers from other substances in the AAI group that are based on fatty acids with polyamines, in that it contains a high amount of hydroxylated polyethylene amines, causing it to display more neutral OH groups rather than basic primary amine groups. As toxicity is much related to the presence of free primary amine groups, it can be expected that in specifically in aspects of acute toxicity related to direct chemical interactions, this substance shows less effects compared to other AAI substances.
Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products was tested for primary irritation according to FDA - Fed.Reg. 37(244),27635, 1972. The intact and abraded skin of 6 rabbits was exposed to 0.5 mL of the test substance for 24 hour exposure 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 substance would be classified as moderate skin irritant.
An indication for possible threshold effects for irritation comes from an available sensitisation study onFatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products: In a Guinea pig maximization study for dermal sensitisation, a preliminary irritation study evaluated irritation from epidermal exposures to the substance for 24 hrs under occlusion. The highest non-irritating concentration for epidermal exposures was established at 2% in water. Epidermal concentrations of 5% were slightly irritating.
Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-productswas extremely irritant to the eyes of 3 male and 3 female rabbits after single instillation of 0.1 ml. The test was terminated after 24h for humane reasons.
There are no data from inhalation studies. However, exposure by inhalation is not likely considering the high boiling point (> 300 °C) and very low vapour pressure ( 8.4 x 10 -8 Pa at 25°C).
Justification for selection of skin irritation / corrosion endpoint:
Only study available
Justification for selection of eye irritation endpoint:
Only study available
Effects on skin irritation/corrosion: moderately irritating
Effects on eye irritation: corrosive
Justification for classification or non-classification
Tall oil + ammonia-ethanolamine reaction by-products was extremely irritant to the eyes of 3 male and 3 female rabbits after single instillation of 0.1 ml. The test was terminated after 24h for humane reasons.
Consequently, classification as skin irritant (GHS Cat.2) and corrosive to eyes (GHS Cat.1) is appropriate.
There is no data from inhalation studies. However, in view of the very low vapour pressure ofFatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products, exposure by inhalation is not likely.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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