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EC number: 270-151-7 | CAS number: 68411-85-8
- 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:
- 27 April 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- ; 24 hour exposure, occlusive dressing, abraded and non-abraded skin
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: U.S. Federal Hazardous Substances Act Consumer Product Safety Commission16 CFR § 1500.41 - Method of testing primary irritant substances
- Version / remarks:
- Formerly U.S. Federal Hazardous Substances Act Food and Drug Commission 21 CFR § 191.11
- Principles of method if other than guideline:
- - Principle of test: The method of testing the dermal corrosivity and primary irritation of substances referred to in § 1500.3(c)(3) and (4), respectively, is a patch-test technique on the abraded and intact skin of the albino rabbit, clipped free of hair. An equal number of exposures are made on areas of skin that have been previously abraded. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.
- Short description of test conditions: Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of the albino rabbit, clipped free of hair. A minimum of six subjects are used in abraded and intact skin tests. Introduce under a square patch, such as surgical gauze measuring 1 inch by 1 inch and two single layers thick, 0.5 milliliter (in the case of liquids) or 0.5 gram (in the case of solids and semisolids) of the test substance. Dissolve solids in an appropriate solvent and apply the solution as for liquids. The animals are immobilized with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an impervious material, such as rubberized cloth, for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances.
- Parameters analysed / observed: After 24 hours of exposure, the patches are removed and the resulting reactions are evaluated on the basis of the following designated values:
Erythema and eschar formation:
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 formations (injuries in depth) 4
Edema formation:
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 millimeter) 3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) 4
The “value” recorded for each reading is the average value of the six or more animals subject to the test. Readings are again made at the end of a total of 72 hours (48 hours after the first reading). Evaluate the reactions of the abraded skin at 24 hours and 72 hours, as described in this paragraph. Add the values for erythema and eschar formation at 24 hours and at 72 hours for intact skin to the values on abraded skin at 24 hours and at 72 hours (four values). Similarly, add the values for edema formation at 24 hours and at 72 hours for intact and abraded skin (four values). The total of the eight values is divided by four to give the primary irritation score - GLP compliance:
- no
- Remarks:
- Study predates GLP
Test material
- Reference substance name:
- Hydrazinecarboximidamide, 2-[(2-hydroxyphenyl)methylene]-, reaction products with 2-undecanone
- EC Number:
- 270-151-7
- EC Name:
- Hydrazinecarboximidamide, 2-[(2-hydroxyphenyl)methylene]-, reaction products with 2-undecanone
- Cas Number:
- 68411-85-8
- Molecular formula:
- C19H32N4O2
- IUPAC Name:
- 2-{[(6-oxocyclohexa-2,4-dien-1-ylidene)methyl]amino}guanidine; undecan-2-one
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Mobil Chemical Company (Edison, NJ) Lot# 1086
- Expiration date of the lot/batch: not specified
- Purity test date: not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, humidity
- Stability under test conditions: stable for duration of test
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Remarks:
- Albino
- Details on test animals or test system and environmental conditions:
- Details on test animals and environmental conditions not provided.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- Abraded and Non-Abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- Both abbraded and intact skin of the albino rabbit, clipped free of hair were used in this study. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. The test material is held against the skin for 24 hours by a dermal patch covered with an occlusive dressing.
- Observation period:
- 24 and 72 hours post application
- Number of animals:
- Six
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch x 1 inch
- Type of wrap if used: impervious material such as rubberized cloth
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
- Time after start of exposure: 24 hours
OBSERVATION TIME POINTS (indicate if minutes, hours or days): 24 and 72 hours
SCORING SYSTEM:
- Method of calculation: After 24 hours of exposure, the patches are removed and the resulting reactions are evaluated on the basis of the following designated values:
Erythema and eschar formation:
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 formations (injuries in depth) 4
Edema formation:
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 millimeter) 3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) 4
The “value” recorded for each reading is the average value of the six or more animals subject to the test. Readings are again made at the end of a total of 72 hours (48 hours after the first reading). Evaluate the reactions of the abraded skin at 24 hours and 72 hours, as described in this paragraph. Add the values for erythema and eschar formation at 24 hours and at 72 hours for intact skin to the values on abraded skin at 24 hours and at 72 hours (four values). Similarly, add the values for edema formation at 24 hours and at 72 hours for intact and abraded skin (four values). The total of the eight values is divided by four to give the primary irritation score. A primary irritation index score of 5.0 or more was considered to indicate a primary dermal irritant.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 24h / 72h
- Score:
- 0.95
- Remarks on result:
- other: includes both abraded and non-abraded scores
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks:
- Effect persisted at 72 hours in 4 of 6 rabbits
- Remarks on result:
- other: 24 hour exposure, non-abraded
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.7
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks:
- Study terminated at 72 hours
- Remarks on result:
- other: 24 hour exposure non-abraded
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 1 animal had slight edema
- Remarks:
- 24 hour exposure, non-abraded
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- 24 hour exposure, non-abraded
- Other effects:
- Abraded skin Irritation scores (irritation parameter; basis; timepoint; value; max score; reversibility; remarks):
Erythema; mean; 24 hours; ca. 1.0; max score = 1.0; Effect persisted in 4 out of 6 rabbits at 72 hours; 24 hour exposure, abraded
Erythema; mean; 72 hours; ca. 0.7; max scoe = 1.0; not specified, study terminated at 72 hours; 24 hour exposure, abraded
Edema; mean; 24 hours; ca. 0.2; max score = 1.0; Fully reversible within 72 hours; 24 hour exposure, abraded
Edema; mean; 72 hours; ca. 0.0; max score = 0.0; 24 hour exposure, abraded
Applicant's summary and conclusion
- Interpretation of results:
- other: Not Irritating
- Conclusions:
- Hydrazine Carboximidamide, 2-((2-hydroxyphenyl)methylene)-, reaction products with 2 undecanone did not produce evidence of primary skin irritation or corrosion in an in-vivo assay. While the exposure conditions do not align with current GHS criteria, the occlusive dressing and prolonged exposure time represent a worse case sceanrio. The low mean erythema and edema scores following such a prolonged exposure do not warrant classification of Hydrazine Carboximidamide, 2-((2-hydroxyphenyl)methylene)-, reaction products with 2 undecanone as a dermal irritant.
- Executive summary:
The mean erythema and edema scores for Hydrazine Carboximidamide, 2-((2-hydroxyphenyl)methylene)-, reaction products with 2 undecanone on unabraded skin were 1.0 and 0.2 respectively. These findings do not warrant classification of Hydrazine Carboximidamide, 2-((2-hydroxyphenyl)methylene)-, reaction products with 2 undecanone as a dermal irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
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