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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test material was examined for possible irritation and sensitisation activity in an experiment with guinea pigs. The Landsteiner/Draize method was used.
The test material was administered by intradermal injections. The test animals were treated repeatedly, the controls only once. - GLP compliance:
- no
- Remarks:
- The study pre-dates the introduction of GLP
- Type of study:
- other: Landsteiner/Draize method
- Justification for non-LLNA method:
- LLNA not available at the time of testing.
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 Identification: Gardamide
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Remarks:
- albino
- Sex:
- male
- Details on test animals and environmental conditions:
- Sixteen male albino guinea pigs, weighing from 201 to 281 g, were divided into two groups of eight animals each, one test group and one control group.
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- 8 per group (test animals and control)
- Details on study design:
- The test material was administered by intradermal injections. The test animals were treated repeatedly, the controls only once.
PRELIMINARY INVESTIGATIONS
Preliminary observations showed that a concentration of 1 % of the test material induced moderate to severe skin irritation. Therefore, a 1 % dilution of the test material in propylene glycol was used for administration. The dilution was freshly prepared once every week.
A. INDUCTION EXPOSURE
For the induction exposure a 1 % aqueous suspension of the test material was used.
Some days before starting the treatment the right flank of the animals was shaved with electric clippers. Shaving was repeated before each injection and reading if necessary.
During the induction period, the test animals received a total of 10 intradermal injections, 3 times weekly for 3 weeks. The injections were given on different spots on the right flank, within an area of 3 to 4 square cm.
As the first injection, each animal received 0.05 mL of the 1 % dilution; for the 2nd to the 10th injections, 0.1 mL per animal was applied.
B. CHALLENGE EXPOSURE
For the challenge dose a 1 % aqueous suspension of the test material was used.
Two weeks after the 10th induction injection, the challenge dose was given in an amount of 0.05 mL of the 1 % aqueous suspension per animal.
The reaction sites were examined 24 hours after the injection. Diameter, colour and thickness were used as criteria for the intensity of the reaction. - Challenge controls:
- At the same time as the challenge exposure in the test animals, the control animals were injected with 0.05 mL of the 1 % aqueous suspension of the test sample. The reaction sites were examined 24 hours after the injection. Diameter, colour and thickness were used as criteria for the intensity of the reaction.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Results
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Table 1 shows the number of individual positive skin reactions observed during the induction and challenge period with the test material.
The test material caused mild to severe skin reactions upon repeated intradermal injections in all animals during the induction period. The challenge dose provoked moderate to severe reactions in all test animals and in all controls which were injected at the same time.
In general, the reactions in the controls were even more pronounced than in the test animals.
From these results it can be concluded that no sensitisation occurred after treatment with the test material.
Table 1: Individual Positive Reactions Observed During the Induction and Challenge Phase
Test Animals |
Control Animals |
||||||||||||
Animal number |
Individual direct reactions at each injection during the induction phase |
Challenge |
Animal number |
Challenge |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
||||
1836 |
++ |
++ |
++ |
++ |
+ |
++ |
+++ |
++ |
+++ |
++ |
++ |
1844 |
+++ |
1837 |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
+++ |
+++ |
++ |
++ |
1845 |
+++ |
1838 |
+ |
+ |
++ |
++ |
++ |
++ |
+ |
+++ |
++ |
+++ |
+++ |
1846 |
+++ |
1839 |
++ |
+ |
++ |
+++ |
+ |
+ |
++ |
++ |
++ |
++ |
++ |
1847 |
++ |
1840 |
++ |
++ |
++ |
+ |
+ |
++ |
++ |
+ |
++ |
+++ |
++ |
1848 |
+++ |
1841 |
++ |
+ |
++ |
++ |
++ |
++ |
+++ |
+++ |
++ |
+++ |
++ |
1849 |
++ |
1842 |
++ |
++ |
++ |
++ |
++ |
+++ |
++ |
++ |
++ |
++ |
++ |
1850 |
+++ |
1843 |
++ |
+++ |
+++ |
+++ |
++ |
++ |
++ |
+++ |
+++ |
++ |
++ |
1851 |
+++ |
Degree of reaction:
+ = Mild
++ = Moderate
+++ = Severe
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Gardamide was concluded to be not sensitising in a guinea pig Landsteiner/Draize test. The study was conducted prior to the introduction of GLP or the applicable OECD test guideline.
- Executive summary:
In an experiment with male albino guinea pigs, the test material was examined for sensitisation properties using the Landsteiner/Draize test.
The test material was administered by intradermal injections. The test animals were treated repeatedly, the controls only once. Preliminary observations showed that a concentration of 1 % of the test material induced moderate to severe skin irritation. Therefore, a 1 % dilution of the test material in propylene glycol was used for administration. For the challenge dose, a 1 % aqueous suspension of the test material was used.
During the induction period, the test animals received a total of 10 intradermal injections, 3 times weekly for 3 weeks. The injections were given on different spots on the right flank.
Two weeks after the 10th injection, the challenge dose was given. At the same time, the control animals were injected with the 1 % aqueous suspension of the test sample. The reaction sites were examined 24 hours after the injection. Diameter, colour and thickness were used as criteria for the intensity of the reaction.
The test material caused mild to severe skin reactions upon repeated intradermal injections in all animals during the induction period. The challenge dose provoked moderate to severe reactions in all test animals and in all controls which were injected at the same time. In general, the reactions in the controls were even more pronounced than in the test animals.
From these results, it can be concluded that no sensitisation occurred after treatment with the test material.
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