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EC number: 629-735-0 | CAS number: 1226892-50-7
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2 May 1990 - 13 June 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study performed similar to standard guideline and under GLP. There is no CoA avaialble for the test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Extra exposure periods were added; 3-minute, 1-hour, and 4-hour applications.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tall oil, reaction products with tetraethylenepentamine
- EC Number:
- 271-417-5
- EC Name:
- Tall oil, reaction products with tetraethylenepentamine
- Cas Number:
- 68555-22-6
- IUPAC Name:
- 68555-22-6
- Reference substance name:
- Tall oil, reaction products with tetraethylene-pentamine (Amidoamine/Imidazoline)
- IUPAC Name:
- Tall oil, reaction products with tetraethylene-pentamine (Amidoamine/Imidazoline)
- Details on test material:
- Description : opaque, darkplum-coloured, slightly viscous liquid
Container : glass screw-top bottle
Label: CATIMULS 404
Reference: 16085
Storage conditions: room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., England
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.22-2.50 kg
- Housing: individuall y housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: minimal 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 60-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: No data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- 3-minute, 1-hour, and 4-hour applications
- Observation period:
- 3-minute: 7 days
1-hour: 7 days
4-hour: 14 days - Number of animals:
- 3-minute: 6 animals
1-hour: 6 animals (same as for 3 min exposure)
4-hour: 3 animals - Details on study design:
- TEST SITE
- Area of exposure: flanks, for 3 minutes the left flank was exposed, 7 days later for 1 hour left flank was exposed of the same animals. 3 new animals were used for the 4 hour exposure and the left flank was exposed.
- % coverage: 2.5 x 2.5 cm guaze patches
- Type of wrap if used:
The patch was secured in position over the test material with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). The trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: after 3 minutes, 1 hour of 4 hours.
SCORING SYSTEM: according to draize (Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas,
"The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics")
EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation Value
No erythema ........................................................ . 0
Very slight erythema (barely perceptible) 1
Well -defined erythema ........................................ 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) .....................................4
Oedema Formation
No oedema ......................................................... 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by
definite raising) 2
Moderate oedema (raised approximately 1
millimetre) ..................................................... 3
Severe oedema (raised more than 1 millimetre
ending beyond the area of exposure) 4
Results and discussion
In vivo
Results
- Time point:
- other: 14 days
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: 4 hour exposure: on day 14 scoring was not possible due to the corrosive effecst of the test substance
- Irritant / corrosive response data:
- 3 minute exposure
Incidents of very slight erythema were noted up to 72 hours after patch removal. Desquamation was noted at one treated skin site. No other adverse
dermal reactions were observed. No corrosive effects were noted.
1 hour exposure
Well-defined erythema was noted at all treated skin sites one hour after patch removal. Haemorrhage of the dermal capil laries was aso commonly
noted. On occasions the reactions extended beyond the site of application. Well-defined or moderate to severe erythema persisted at all treated skin
sites up to the 72-hour observation. Other adverse reactions commonly noted at these times were light brown discolouration of the epidermis and
haemorrhage of the dermal capillaries. The reactions extended beyond the site of application in two animals.
One animal was found dead on day 4 of the test. This was not treatment related and did not affect the integrity of the study. The remaining animals all showed hyperkeratinisation when observed on day 7. One animal also showed signs of reduced re-growth of fur at this time. Slight to severe oedema was observed at all treated skin sites one hour after patch removal. The oedema dropped ventrally below the treatment site in one animal. Slight to severe oedema was observed at the 24-hour observation and slight to moderate oedema persisted at all treatment sites up to 72 hours after patch removal. No oedema formation was observed in the remaining animals on day 7. No corrosive effects were noted.
4 hour exposure
Severe erythema and green-coloured necrosis was noted at all treated skin sites one hour after patch removal. Well-defined er,ythema surrounded the scabs and two treatment sites showed haemorrhage of the dermal capillaries. These reactions persisted at the 24-hour observation.
At the 48-hour observation and for the duration of the study it was not possible to evaluate the erythema due to the other adverse dermal effects. These included hardened dark brown/black-coloured or undulating scabs, light brown discolouration of the epidermis, blanching, well -defined or moderate erythema surrounding the scabs, desquamation, hyperkeratinisation, scabs, lifting to reveal further deep scabbing and scar tissue.
Severe oedema was noted one and 24 hours after patch removal. At the 48-hour observation it was not possible to evaluate the oedema at two treatment sites due to the degree of thickening. The remaining treatment site showed moderate oedema at this time and at the 72-hour observation. On days 7 and 14 it was not possible to evaluate the oedema at any treated skin site. On occasions during the study the oedema was observed to extend beyond the site of application.
The dermal responses seen in all three animals were considered to be indicative of corrosion.
Any other information on results incl. tables
Legenda
N = green-coloured necrosis
Me = moderate erythema surrounding scab
We = well-defined erythema surrounding scabs
Hy = hyperkeratinisation
?e = evaluation of erythema not possible due to adverse dermal reactions
St = hardened dark brown/black-coloured scabs
Sw = undulating scab
B7 = blanching
D = desquamation
Sd = scab lifting to reveal further deep scabbing
?Od = degree of thickening precluded evaluation of oedema
R = reactions extends beyond treatment site
Hd = haemorrhage of the dermal capillaries
Br = light brown discolouration of the epidermis
Sc = scar tissue
Fr = reduced re-growth of fur
Oe = oedema drops ventrally below treatment site
* = animal found dead on day 4 of the study
3 minute exposure
Skin Reaction | Reading (Hours) | Individual score - Rabbit No. and Sex | ||||||
97 | 115 | 119 | 123 | 129 | 130 | |||
Male | Male | Female | Male | Male | Male | |||
Erythema/eschar formation | 1 | 0 | 1 | 1 | 1 | 0 | 0 | |
24 | 0 | 1 | 1 | 1 | 0 | 0 | ||
48 | 0 | 0 | 1 | 0 | 0 | 0 | ||
72 | 0 | 0 | 1D | 0 | 0 | 0 | ||
7 days | 0 | 0 | 0D | 0 | 0 | 0 | ||
oedema formation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
24 | 0 | 0 | 0 | 0 | 0 | 0 | ||
48 | 0 | 0 | 0 | 0 | 0 | 0 | ||
72 | 0 | 0 | 0 | 0 | 0 | 0 | ||
7 days | 0 | 0 | 0 | 0 | 0 | 0 |
1 hour exposure
Skin Reaction | Reading (Hours) | Individual score - Rabbit No. and Sex | ||||||
97 | 115 | 119 | 123 | 129 | 130 | |||
Male | Male | Female | Male | Male | Male | |||
Erythema/eschar formation | 1 | 2Hd | 2RHd | 2RHd | 2Hd | 2R | 2Hd | |
24 | 3HdBr | 2HdBr | 2HdBrR | 2HdBr | 2R | 2Hd | ||
48 | 3Br | 2Br | 2HdBrR | 2Br | 2R | 2Hd | ||
72 | 3Br | 2Br | 2BrR | 2Br | 2R | 2Br | ||
7 days | 0Hy | 0Hy | 0HyFr | 0Hy | 0Hy | * | ||
oedema formation | 1 | 4 | 4 | 3 | 30e | 2 | 2 | |
24 | 4 | 3 | 3 | 3 | 2 | 2 | ||
48 | 3 | 3 | 3 | 3 | 3 | 2 | ||
72 | 2 | 3 | 3 | 3 | 3 | 2 | ||
7 days | 0 | 0 | 0 | 0 | 0 | * |
4 hour exposure
Skin Reaction | Reading (Hours) | Individual score - Rabbit No. and Sex | ||||||
24 | 35 | 48 | ||||||
Female | Male | Male | ||||||
Erythema/eschar formation | 1 | 4NWe | 4NhdWe | 4NhdWe | ||||
24 | 4NWe | 4NhdWe | 4NhdWe | |||||
48 | ?eStSwWe | ?eStBrBlMe | ?eStSwWe | |||||
72 | ?eStSwWeBl | ?eStSwBrBlMe | ?eStSwWeBl | |||||
7 days | ?eStSwD | ?eStSwHy | ?eStSw | |||||
14 days | ?eSdD | ?eScD | ?eSdD | |||||
oedema formation | 1 | 4 | 4 | 4 | ||||
24 | 4R | 4R | 4 | |||||
48 | ?0d | 3R | ?0d | |||||
72 | ?0d | 3R | ?0d | |||||
7 days | ?0d | ?0d | ?0d | |||||
14 days | ?0d | ?0d | ?0d |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The test material produced evidence of visible necrosis following an exposure period of up to four hours and no recovery was observed within 14 days.
- Executive summary:
The study was based on the recommendations of the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" and performed under GLP.
In total 9 new zealand white rabbits were dermally exposed under semi-occlusion to 0.5ml of the undiluted test substance. 6 rabbits were first exposed for 3 minutes on their left flank, 7 days later the same animals were exposed on their right flank for 1 hour. The other three animals were exposed for 4 hours on their left flank. After exposure the test substance was removed by gentle swabbing with cotton wool soaked in distilled water. Obervations were made at 1 , 24, 48 72 hours and after 7 days. The animals exposed for 4 hours were observed up to 14 days.
After 3 minutes exposure slight effects were observed and these were reversible after 7 days. Irritation was observed after the 1 hour exposure and these effects were not revesible within 7 days. The test material produced evidence of visible necrosis following an exposure period of up to four hours and no rceovery was observed within 14 days. Based on this study the test substance should be regarded as corrosive to skin.
This study on Tall oil, reaction products with tetraethylene-pentamine (Amidoamine/Imidazoline) is valid for the evaluation of Tall oil fatty acids, reaction products with polyethylenepolyamines (Amidoamine):
All 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 are therefore not expected to differ much between these substances. In case of no imidazoline forming as is the case for Tall oil fatty acids, reaction products with polyethylenepolyamines (Amidoamine), makes thatthere are more free available primary amine groups available compared to the situation that imidazolines are formed. This is expected to have an increasing effect on its irritating properties.
As all in vivo skin irritation/corrosion studies performed on AAI substances all indicate them to be corrosive following 4 hour exposure. Also, there seems to be no big difference in response with the variation on EA length used for the production of the AAI. Consequently, similar results can be expected for Tall oil fatty acids, reaction products with polyethylenepolyamines (Amidoamine).
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