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EC number: 947-979-9 | CAS number: -
- 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:
- 29 April 1987 - 6 May 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study is performed under GLP and according to OECD 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute 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:
- Description: amber-coloured liquid
Container: glass screw-top bottle
Sponsor's identification : AMPHOLAK X00-30P
Date of arrival : 15 April 1987
Storage conditions : room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K. and Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.40 -3.12 kg
- Housing: Individually housed in suspended metal cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 55-60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 29 April 1987 - 6 May 1987
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:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm
- % coverage: no data
- Type of wrap if used: A quantity of 0.5ml of the test material was introduced under a 2.5 cm x 2.5 cm gauze patch and placed i n position on the shorn skin. The patch was secured i n position over the test material with a strip of surgical adhesive tape (BLENDERN: approximate size 25 m x 40 mm). To prevent the animals from interfering w i t h the patches the trunk of each I rabbit was wrapped in an elasticated corset (TUBIGRIP).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: According to 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:
- 0.53
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Irritant / corrosive response data:
- Very slight erythema was noted at all test sites one hour after removal of the wrapping and at the 24-hour observation but persisted at only one test site at the 48 and 72-hour observations. Very slight oedema was noted at all test sites one hour after removal of the wrapping but at only one test site at the 24-hour observation. All test sites appeared normal on day seven.
Any other information on results incl. tables
Summary of dermal lesions (following 4-h application)
no. |
Effect |
Hour |
Days after application |
Mean score erythema 24/48/72 h |
Mean score oedema 24/48/72 h |
|||
1 |
1 |
2 |
3 |
7 |
||||
31 |
Erythema/ eschar Oedema |
1 1 |
1 0 |
0 0 |
0 0 |
0 0 |
0.3 |
0.0 |
68 |
Erythema/ eschar Oedema |
1 1 |
1 0 |
0 0 |
0 0 |
0 0 |
0.3 |
0.0 |
90 |
Erythema/ eschar Oedema |
1 1 |
1 0 |
1 0 |
1 0 |
0 0 |
1.0 |
0.0 |
Mean |
0.53 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test material was found to be non-i rritant to rabbit skin according to GHS.
- Executive summary:
A skin irritation/corrosion study was carried out in order to assess the irritancy potential of a test material following a single 4-hour, semi-occluded application to the intact rabbit skin. The study was designed to comply with the recommendations of the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" and was performed under GLP. Very slight erythema was noted at all test sites one hour after removal of the wrapping and at the 24-hour observation but persisted at only one test site at the 48 and 72-hour observations. Very slight oedema was noted at all test sites one hour after removal of the wrapping but at only one test site at the 24-hour observation. All test sites appeared normal on day seven. The test material was found to be non-i rritant to rabbit skin according to GHS.
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