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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 282-817-4 | CAS number: 84434-18-4
- 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:
- 1988-04-05 to 1988-04-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- The study pre-dates the introduction of GLP
Test material
- Reference substance name:
- N,2-dimethyl-N-phenylbutyramide
- EC Number:
- 282-817-4
- EC Name:
- N,2-dimethyl-N-phenylbutyramide
- Cas Number:
- 84434-18-4
- Molecular formula:
- C12H17NO
- IUPAC Name:
- N,2-dimethyl-N-phenylbutanamide
- Reference substance name:
- Unknown impurities
- Molecular formula:
- Unknown
- IUPAC Name:
- Unknown impurities
- Test material form:
- liquid
Constituent 1
impurity 1
- Specific details on test material used for the study:
- Substance name: Gardamide
Storage: Ambient
Stability: Stable to air and sunlight
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- New Zealand white rabbits, bought from commercial supplier, are used for testing when the hair is in the telegon (non-growh) phase of the hair cycle. Three to four days prior to testing, the dorsal area of thee trunk of healthy adult animals are clipped to identify those which are in telogen and which have no skin blemishes. Of these suitable rabbits, at least three and normally are selected for the test. A final clipping of the test animals is made approximately twenty-four hours before testing.
Throughout testing the rabbits are caged individually and have free access to water and pelleted food.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated skin of each animal serves as its own control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration: 100 % - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Rabbits are used for testing when the hair is in the telogen (non-growth) phase of the hair cycle. Three to four days prior to testing, the dorsal area of the trunk of healthy adult animals is clipped to identify those which are in telogen and which have no skin blemishes. A final clipping of the test animals is made approximately twenty-four hours before testing.
- Test patch: The test material is applied to a semi-occlusive patch. Each patch consists of a 25 x 25 mm gauze pad, backed by a 20 x 30 mm strip of thin polythene film stuck to a 25 x 75 mm strip of zinc oxide sticking plaster.
- Type of wrap if used: After patch application, each rabbit is immobilised in a canvas body sleeve and placed in a quiet place for the exposure duration.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After patch removal, excess test material is wiped from the skin with a damp tissue.
- Time after start of exposure: 4 hours
ASSESSMENT OF IRRITATION
Animals are observed for signs of erythema and oedema and the responses graded at thirty to sixty minutes, and then at twenty-four, forty-eight, and seventy-two hours after patch removal. Dermal irritation is graded and recorded according to the system below. Further observations may be needed, as necessary, to establish lesions such as corrosion (irreversible destruction of skin tissue). Other toxic effects should be fully described.
SCORING SYSTEM:
>Erythema and eschar formation scores
0 = No erythema
1 = Very slight erythema
2 = Well defined erythema
3 = Moderate to severe erythema
4 = Severe erythema (beet redness) to slight eschar formation (injuries in depth)
>Oedema formation
0 = No oedema
1 = Very slight oedema (barely perceptible)
2 = Slight oedema (edges of area well defined by definite raising)
3 = Moderate oedema (edges raised by approximately 1mm)
4 = Severe oedema (raised more than 1mm and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hour
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: Mean of 24, 48 and 72 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: Mean of 24, 48 and 72 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: Mean of 24, 48 and 72 hour
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: Mean of 24, 48 and 72 hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Two animals showed slight erythema of 48 hours duration. One animal showed marked erythema with a small area if necrosis. Histological examination of this area revealed shallow necrosis.
Any other information on results incl. tables
Table 1: Daily Macroscopic Assessment of Irritation Reactions
Animal Number |
Erythema |
Oedema |
||||||||
1 Hour |
24 Hours |
48 Hours |
72 Hours |
Mean |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
Mean |
|
9589 |
0 |
1 |
1 |
0 |
0.67 |
0 |
0 |
0 |
0 |
0 |
9457 |
3* |
4** |
4 |
4 |
4 |
3 |
2 |
2 |
2 |
2 |
9401 |
0 |
1 |
1*** |
0 |
0.67 |
0 |
0 |
0 |
0 |
0 |
* 0.5 x 0.5 cm patch of beet-red tissue
** 0.5 x 0.5 cm area of dark red/brown tissue
*** Skin starting to crack
The skin site of exposure from animal number 9457 was examined histologically. The depth of necrosis/slough was determined to be trace/well developed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test material was determined to be not irritating to the skin.
- Executive summary:
The skin irritation potential of the test material was investigated in a study which was conducted in accordance with the standardised guideline EU Method B.4.
During the study 0.5 mL of the undiluted test material was applied to the clipped skin of three healthy New Zealand White rabbits for 4 hours in a semi-occlusive fashion.
Irritation reactions were assessed one hour after removal of the patch and thereafter at 24, 48, and 72 hours.
One animal showed slight erythema for a duration of 48 hours. One animal showed marked erythema and moderate oedema, with a small area of necrosis. Histological examination of this area revealed shallow necrosis.
Under the conditions of this study, the test material was determined to be not irritating to the skin. I
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.