Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 945-910-7 | 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:
- weight of evidence
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study follows protocols to similar to a recognised guideline under GLP.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl 2-[[(2,4-dimethyl-3-cyclohexen-1-yl)methylene]amino]benzoate
- EC Number:
- 272-449-2
- EC Name:
- Methyl 2-[[(2,4-dimethyl-3-cyclohexen-1-yl)methylene]amino]benzoate
- Cas Number:
- 68845-02-3
- Molecular formula:
- C17H21NO2
- IUPAC Name:
- methyl 2-[[(2,4-dimethylcyclohex-3-en-1-yl)methylidene]amino]benzoate
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: liquid
- Other: yellow
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Recognised supplier
- Age at study initiation: not reported
- Weight at study initiation: 2.4 - 3.0 Kg
- Housing: individually housed in grid-bottomed metal cages.
- Diet (e.g. ad libitum): certified pelleted diet ad libitum
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 51 - 77
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5ml test material applied to clipped backs of test animals and over areas of approximately 6sqcm
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- skin reaction to the test article was assessed after one, 24, 48, 72, 168 and 336 hours. Additional assessments were carried out 7 and 14 days after dosing.
- Number of animals:
- 4 females
- Details on study design:
- TEST SITE
- Area of exposure: doral surface of the trunk
- % coverage: not reported. 6 sq. centimetres is described as the treatment site using a 2.5 x 2.5 cm lint pad held in place with an adhesive bandage.
- Type of wrap if used: Elastoplast elastic adhesive bandage 10cm wide.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes - test substance application site cleansed using cotton wool soaked in warm water (37°C)
- Time after start of exposure: 4 hours
SCORING SYSTEM: Consistent with Draize et al. under European Communities No. L257, 16th September 1983 was used to classify the material. (Commission Directive of 29th July 1983 adapting technical progress for the fifth time, Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances) criteria.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 14 days
- Score:
- 1.25
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0.75
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hour
- Score:
- 1.75
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hour
- Score:
- 2.25
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 14 days
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritant / corrosive response data:
- Individual scores are presented in the full study report and presented in table 1.
Any other information on results incl. tables
Table 1. individual scores
|
Time |
Erythema |
Oedema |
Comments |
|
|
|
|
|
1 |
1 hour |
2 |
1 |
|
2 |
|
2 |
0 |
|
3 |
|
1 |
1 |
|
4 |
|
1 |
1 |
|
1 |
24 hours |
2 |
2 |
|
2 |
|
2 |
1 |
|
3 |
|
2 |
2 |
|
4 |
|
2 |
2 |
|
1 |
48 hours |
2 |
2 |
|
2 |
|
2 |
2 |
|
3 |
|
2 |
2 |
|
4 |
|
2 |
2 |
|
1 |
72 hours |
2 |
3 |
|
2 |
|
2 |
2 |
|
3 |
|
2 |
2 |
|
4 |
|
2 |
2 |
Treated skin thickened |
1 |
7 days |
2 |
3 |
Treated skin thickened |
2 |
|
2 |
3 |
Treated skin thickened |
3 |
|
2 |
3 |
Treated skin thickened |
4 |
|
2 |
3 |
Treated skin thickened |
1 |
14 days |
1 |
0 |
Slight desquamation |
2 |
|
2 |
2 |
Desquamation |
3 |
|
1 |
1 |
Slight desquamation |
4 |
|
1 |
1 |
Slight desquamation |
|
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study the test substance is considered to be irritating to skin.
- Executive summary:
The study was performed in a method equivalent or similar to EU Method B.4 under GLP to assess the irritancy potential of the test substance to the skin of the New Zealand White rabbit. The test substance was applied over an area of approximately 2.5cm square to the clipped backs of 4 albino rabbits. The test substance was held in contact with the skin under a semi-occlusive patch for a 4 hour period. After this time the patches were removed and the skin reaction to the test substance was assessed after one, 24, 48 and 72 hours. Additional assessments were carried out 7 and 14 days after dosing to determine the degree of reversibility of the skin reaction. The response increased within twenty four hours of dosing when well defined erythema of the skin was noted in all four animals. Slight oedema was apparent and very slight oedema of the skin was observed. Well defined erythema and slight oedema were observed at the treated sites at the forty eight hour observation. Seventy two hours after dosing slight increase in oedematous reaction had occurred in one animal and thickening of the treated skin was observed in a second animal. Well defined erythema, moderate oedema and thickening of the treated skin was observed in all organisms seven days after dosing. This reaction declined and fourteen days after dosing well defined erythema and slight oedema remained in one organism, and very slight irritation was observed at the treated sites of the remaining organisms. Desquamation from the skin surface was noted in all four rabbits of the group. Applicant recalculation of the results indicates that under the conditions of this study, that the mean erythema scores between 24 and 72 hours were > 2.0 in at least 3 of 4 organisms and the response had not fully reversed within a 14 day period. The test item should be considered as irritating to the skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.