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EC number: 825-403-6 | CAS number: 2060541-51-5
- 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
- Study period:
- 14 September 1993 - 19 September 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed under GLP and according to OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts
- EC Number:
- 307-458-3
- EC Name:
- Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts
- Cas Number:
- 97659-53-5
- Details on test material:
- Identity: Ampholak 7CX
Chemical name: Cocoamphopolycarboxyglycinate
Ref No.: 19882,1458
Batch number: FP 91327
Expiry: 18 August 1995
Purity: 27% in water
Appearance: Clear amber liquid
Storage conditions: Room temperature
Date received: 18 August 1993
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.R.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2.2-2.6 kg
- Housing: housed individually in metal cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes, time not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 14 September 1993 - 19 September 1993
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 6 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 25 mm x 25 mm gauze pad to one intact skin site on each animal.
- % coverage: no data
- Type of wrap if used: Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30°C to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Scoring system Erythema and oedema
Erythema and eschar formation
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema formation
0 No oedema
1 Very slight edema(barely perceptible)
2 Slight edema(edges of the area well defined by definite raising)
3 Moderate edema(raised approximately 1mm)
4 Severe edema( raised more than 1 mm and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- Well defined erythema wjth very slight oedema was seen in all three animals on Day 1. These reactions gradually ameliorated and had resolved completely by Day 6.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Any other information on results incl. tables
Summary of dermal lesions (following 4-h application)
Animal no. |
Effect |
Hour |
Days after application |
Mean score erythema 24/48/72 h |
Mean score oedema 24/48/72 h |
||||
1/2 |
1 |
2 |
3 |
4 |
5 |
||||
2457 |
Erythema/ eschar Oedema |
2 1 |
1 0 |
1 0 |
1 0 |
1 0 |
0 0 |
1 |
0 |
2458 |
Erythema/ eschar Oedema |
2 1 |
1 1 |
1 0 |
1 0 |
1 0 |
0 0 |
1 |
0.3 |
2459 |
Erythema/ eschar Oedema |
2 |
1 1 |
1 0 |
1 0 |
1 0 |
0 0 |
1 |
0.3 |
Mean |
1 |
0.2 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- A single semi-occlusive application of the test material to intact rabbit skin for four hours elicited slight to well-defined dermal reactions. All reactions had resolved by Day 6. The composition of the test material is estimated to be 40% active ingredient (incl NaCl) and 60 % water. Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts (CAS no 2060541-51-5) is therefre not classified as irritating to skin under GHS.
- Executive summary:
A study was performed to assess the in-vivo skin irritation potential of the test material consisting with a composition of 40% active ingredient (incl NaCl) and 60 % water. The method followed was that described in EEC Methods for the determination of toxicity, Annex to Directive 92/69/EEC (OJ No. L383A, 29.12.92), Part B, Method B.4. Acute toxicity (skin irritation). Three rabbits were each administered a single dermal dose of 0.5 ml of the test substance and observed for six days. A single semi-occlusive application of the active ingredient to intact rabbit skin for four hours elicited slight to well-defined dermal reactions in all three animals. All reactions had resolved by Day 6. Based on the result, test substance Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts (CAS no 2060541-51-5) is not classified as irritating to skin under GHS.
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