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EC number: 402-990-3 | CAS number: 163702-01-0 ESACURE KIP 100; ESACURE KIP 150
- 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
Study conducted to recognised testing guidelines with GLP certification.
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
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Organization for Economic Cooperation and Development (1981) OECD Short-Term and LongvTerm Toxicology Groups. Final Report: Acute Dermal Irritation & Corrosion
Cater, R.O. & Griffith, J.F., (1965). Experimental Basis for the Realistic Assessment of Safety of Topical Agent. Toxicol. Appl. Pharm. 1., 60-75. - Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animal origin:
"Padre Antonio" breeding center, Mariano Comense - CO— Italy
Weight:
2.000 - 3.000 kg
Housing:
Environmental conditions
Housing overpressure environment compared to the external atmosphere, maintained at following conditions:
Temperature: 0 °C ± 3 °C
Humidity: 55% ± 15% Relative humidity
Air parts: At least eight per hour
Cages:
Model 1472 stainless steel cages of the company "Tecuiplast" Gazzada (Varese). Cycle of 10 seconds automatic washing every 60 minutes.
Food supply:
Complete pelletized diet
Acgua:
"Ad libitum". Municipal water supply system filtered with Seitz filter, chemically and bacteriologically analyzed twice a year.
Quarantine:
One week
Preparation of animals:
Animal health conditions are check 24 hours before the test starts. The back of the animals is shaved by doing be careful not to damage the skin. Only animals with intact skin are used. - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 1.0 g/animal
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- After 24 hours the gauze is removed and the skin reactions are immediately evaluated. The evaluation is then repeated 72 hours after application. The skin reactions are re-evaluated after five and seven days to determine the reversibility or irreversibility of the lesions observed.
- Number of animals:
- 6
- Details on study design:
- Administration:
The back and sides of the animals are shaved. Two areas about 10 cm apart. are designated for affixing the material in question.
The fiance area is abraded by practicing with the tip of a needle three light epidermal incisions along parallel lines, of about 3 cm. and distant 0.5 cm.
The engravings are of exclusive interest the stratum corneum and are not so deep as to cause bleeding. The material under examination is absorbed on two surgical gauze tablets (2.5x2.5 cm) consisting of 12 layers.
The two tablets are fixed to the sides of the animal using a hypoallergenic adhesive tape (Blenderm BM). The entire trunk of the animal is further protected by an elastic bandage (Acrylastic Beyersdorf AG Hamburg). - Irritation parameter:
- erythema score
- Remarks:
- Intact and scarified
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- Intact and scarified
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- Intact and scarified
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- Intact and scarified
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- Intact and scarified
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- Intact and scarified
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact and scarified
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact and scarified
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact and scarified
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact and scarified
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact and scarified
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact and scarified
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance does not meet the criteria for classification under CLP.
- Executive summary:
In this guideline study, the test substance (EC 402-990-3) was found not to meet the criteria for classification as a skin irritant/corrosive under CLP.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Organisation for Economic Co-operation and Development (1979).
OECD Short-term and Long-term Toxicology Groups, Final Report:
Acute Eye Irritation/Corrosivity, 31 December, p. 40 - Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
Source: "Padre Antonio" Mariano breeding center
Weight: 2.000-3.000 Kg.
Quarantine: A week
Diet: Pellets
Water: water
Ad libitum. Municipal water supply system filtered with Seitz filter, chemically and bacteriologically analyzed twice a year.
Preliminary selection: Animal health conditions are check 24 hours before the test. All animals with irritation or other eye defects are discarded
ENVIRONMENTAL CONDITIONS
Pressure: Atmospheric pressure
Humidity: 55 ± 15% relative humidity
Air changes (per hr): At least 8
Cages: Model 1472 stainless steel cages of the"Tecniplast" company ~ Gazzada - VA - Italy - with automatic washing cycle 10 seconds every 60 minutes - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1g/animal applied once
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- The eyes of rabbits were examined at intervals of 1-24-48-72 hours from application. In the cases where corneal damage or irritation occurs persistent ocular examination, additional observations were conducted for the purpose of determining the reversibility or irreversibility of any injuries observed.
- Number of animals or in vitro replicates:
- One group of 6 animals
- Details on study design:
- The material under examination is instilled in the outer corner of the right eye of each rabbit slightly pushing the lower eyelid apart. After instillation the eyelids are closed and pressed lightly so as to avoid any loss of material. It is the untreated left eye that served as a control.
The eyes of the rabbits were examined in the following order: a) conjunctiva, b) iris, c) cornea. The lesions of the iris and cornea were exami ned either for direct observation and for lighting with ultraviolet lamp (365 nm) later fluorescein instillation.
The severity of injuries is expressed in points, according to the numerical scale illustrated in the annex table 1 (Draize, J. It., Woodward, G. and Calvary, H. 0. (1944). Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the skin and Mucous Membranes, J. Pharmacol. Exp. Ther. 82 377-390).
Any other injury not relevant to the cornea, iris or conjunctiva data was also recorded and reported. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- All animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- All animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance EC 402-990-3 is not classified as an eye irritant under CLP.
- Executive summary:
In this guideline study, the substance (EC 402-990-3) is not sufficiently irritant to be classified under CLP criteria.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The substance does not meet the criteria for classification in accordance with the classification, labelling and packaging regulation (EC 1272/2008).
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