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EC number: - | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 31, 1981 to April 14, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A study was conducted with the test substance following application of single dose to one of the eyes of the experimental animal and the untreated eye serves as the control. The degree of eye irritation/corrosion was evaluated by scoring lesions of conjunctiva, cornea, and iris, at specific intervals. Other effects in the eye and adverse systemic effects were also described to provide a complete evaluation of the effects.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Protein hydrolyzates, keratin, reaction products with 3-chloro-2-hydroxypropyl-cocoalkyl-dimethylammonium chloride
- Molecular formula:
- Molecular formula of major active constituents: C22H45Cl1N2O5 (representative molecular formula for C12 alkyl chain quaternised glutamic acid) C20H43CL1N2O3 (representative molecular formula for C12 alkyl chain quaternised alanine) C25H50CL1N3O6 (representative molecular formula for C12 alkyl chain quaternised peptides of alanine and glutamic acid)
- IUPAC Name:
- Protein hydrolyzates, keratin, reaction products with 3-chloro-2-hydroxypropyl-cocoalkyl-dimethylammonium chloride
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 24, 48, and 72 h
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- Procedure
This test was designed to determine the ocular irritation potential of the test substance in rabbits. The procedure followed was a modification of that described by J.H. Draize. Six (6) New Zealand White rabbits, weighing approximately 2 kg and about 3 months of age, Sex unspecified, were obtained from a suitably licensed dealer. Animals were checked carefully upon receipt for ocular defects, diarrhea and dehydration, respiratory difficulties, postural deficiencies and general condition. Animals were acclimated at least 3 d prior to test initiation. They were housed in galvanized or stainless steel cages and identified through individual markings on the outer ear of each animal, as well as a cage label. Diet consisted of a growth and maintenance ration from a commercial producer, as well as water, libitum. Immediately prior to test initiation, the animals were placed in wooden restrainers. A dose of 0.1 mL of the test substance was placed on one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. The eyelids were gently held together for 1 second. The contralateral eye, remaining untreated, served as control. If any of the test substance remained in the eye at 24 h. the eye was washed out with lukewarm water after the 24 h reading. Observations of ocular irritation were recorded 24, 48 and 72 h following instillation of the test substance. Additional readings were made at 4 and 7 d after application if irritation persisted. An animal was considered as exhibiting a positive reaction if the test substance produced any of the following: ulceration of the cornea other than a fine stippling, opacity of the cornea other than a slight dulling of the normal luster, inflammation of the iris other than a slight deepening of the folds or slight circumcorneal injection of the blood vessels, obvious conjunctival swelling with partial eversion of the lids or a diffuse crimson-red with individual vessels not discernible. If two (2) or more animals exhibited a positive reaction, the test substance was considered an ocular irritant (Unless the test was repeated with another six animals without positive reactions).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No adverse effect reported
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: No adverse effected reported
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No swelling observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 20
- Reversibility:
- other: No adverse effects observed
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Summary of eye irritation
Rabbit |
Day |
Cornea (A*B*5) + |
Iris (A*5) + |
Conjunctivae (A+B+C)*2 - |
|
|
Total score* |
|
Opacity (A) |
Area of cornea involved (B) |
Values (A) |
Redness (A) |
Chemosis (B) |
Discharge © |
|||
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
- |
- |
- |
- |
- |
- |
- |
|
7 |
- |
- |
- |
- |
- |
- |
- |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
- |
- |
- |
- |
- |
- |
- |
|
7 |
- |
- |
- |
- |
- |
- |
- |
3 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
- |
- |
- |
- |
- |
- |
- |
|
7 |
- |
- |
- |
- |
- |
- |
- |
4 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
- |
- |
- |
- |
- |
- |
- |
|
7 |
- |
- |
- |
- |
- |
- |
- |
5 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
- |
- |
- |
- |
- |
- |
- |
|
7 |
- |
- |
- |
- |
- |
- |
- |
6 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
- |
- |
- |
- |
- |
- |
- |
|
7 |
- |
- |
- |
- |
- |
- |
- |
Average |
1 |
|
|
|
|
|
|
0 |
|
2 |
|
|
|
|
|
|
0 |
|
3 |
|
|
|
|
|
|
0 |
|
4 |
|
|
|
|
|
|
- |
|
7 |
|
|
|
|
|
|
- |
*Total score possible/animal/observation interval = 110 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- (no concentration specified)
- Conclusions:
- Under the study conditions, the test substance was determined to be non irritating to the eyes.
- Executive summary:
A study was conducted to determine the eye irritation potential of the test substance, 'Cocodimonium hydroxypropyl hydrolysed keratin' (active: not specified) according to the Draize method, in compliance with GLP. Six (6) New Zealand white rabbits, free from visible ocular defects, each received a single intraocular application of 0.1 mL of the test substance in one eye. The contralateral eye, remaining untreated, served as a control. The test substance was used as received (pH - 6.3). The eyes of all animals remained unwashed for 24 h. Observations of corneal opacity, iritis, and conjunctivitis were recorded 24, 48 and 72 h after treatment, and at 4 and 7 d, if irritation persisted. No irritation effects were observed in all animals. The overall, Draize score was determined to 0. Under the study conditions, the test substance was determined to be non irritating to the eyes (CPT, 1981).
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