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EC number: 214-353-5 | CAS number: 1122-58-3
- 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
- Study period:
- April 16-1992 to July 31-1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to US guideline protocol (Skin Sensitisation)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The Buehler protocol for guinea pigs was used, with closed (occlusive) patches.
- GLP compliance:
- yes
- Type of study:
- other: closed epicutaneous application
Test material
- Reference substance name:
- N,N-dimethylpyridin-4-amine
- EC Number:
- 214-353-5
- EC Name:
- N,N-dimethylpyridin-4-amine
- Cas Number:
- 1122-58-3
- Molecular formula:
- C7H10N2
- IUPAC Name:
- N,N-dimethylpyridin-4-amine
- Test material form:
- other: Solid white to off white powder
- Details on test material:
- - Name of test material: 4-Dimethylaminopyridine
- Physical state: Solid
- Lot/batch No.: 20315AB
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
A total of 28 young healthy animals were used: 14 males and 14 females.
- Source: Elm Hill Breeding Labs, Chelmsford, MA
- Age at study initiation: 21 to 43 days old at the start of the study
- Weight at study initiation: 250 to 400 grams
- Housing: Animals were group housed in stainless steel cages. Hardwood chips (Sani-Chips, JP Murphy Forest Products, Montvale, NJ) were used as contact bedding within the cages.
- Diet: a diet of commercial guinea pig ration (Agway Prolab, Agway, Waverly, NY)
- Water : Ad libitum
- Acclimation period: animals were placed in quarantine for 6 days (Preliminary Irritation Study) and 9 days (Sensitization Study) under the same conditions as for the actual test.
ENVIRONMENTAL CONDITIONS
- Temperature: 68+3°F
- Humidity (%): 30-70%,
- Air changes (per hr): A minimum of 10 to 13 complete air exchanges per hour
- Photoperiod (hrs dark / hrs light): A 12-hour light/dark cycle using full spectrum fluorescent lights
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other:
- Concentration / amount:
- In the Preliminary Irritation Study with four previously unexposed animals, four different concentrations (0.4 ml) were applied by the closed patch technique described above. The concentrations run were 100%, 50%, 25% and 10%.
In the main study, in both Induction and challenge phases, a 50% concentration was used.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other:
- Concentration / amount:
- In the Preliminary Irritation Study with four previously unexposed animals, four different concentrations (0.4 ml) were applied by the closed patch technique described above. The concentrations run were 100%, 50%, 25% and 10%.
In the main study, in both Induction and challenge phases, a 50% concentration was used.
- No. of animals per dose:
- 5 males and 5 females per dose
- Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 Hours after which the skin was washed off
- Test groups: 3 exposures for 6 hrs on the side of the animal
- Control group: Positive control group was applied exactly like the test group
- Site: On one side of the animal.
- Frequency of applications: Once a week for three consecutive weeks.
- Duration: 6 hours
- Concentrations: 50%
A gauze pad was applied directly to the skin over the applied test substance, as soon as possible, and kept in place with occlusive bandaging.
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge:
- Exposure period: 24 hours
- Test groups: 24 hours exposure
- Control group: 24 hours exposure
- Site: Back of the animal
- Concentrations: 50%. During week 5, the challenge test was performed on freshly clipped skin sites in the same way as the 6 hour closed patch test of the induction phase. The skin was exposed to the test substance for 24 h.
- Evaluation): At 24 hours after application of the challenge dose, the area of the challenge was marked and the whole back shaved. Two hours after shaving, the test site was examined for erythema and edema. Reading of the skin area was repeated 48 hours after the challenge and the skin reactions were graded using BUEHLER TOPICAL CLOSED PATCH SENSITIZATION TEST method.
SCALE:
0.0 = No reaction
0.5 = Very gaint erythema, usually confluent.
1.0 = Faint erythema, usually confluent
2.0 = Moderate erythema
3.0 = Strong erythema with or without edema - Challenge controls:
- The day preceding the challenge, a 4 x 3 cm virgin skin site was shaved on the backs of the experimental and control animals.
- Positive control substance(s):
- yes
- Remarks:
- Positive Control Article: Dinitrochlorobenzene
Results and discussion
- Positive control results:
- All 10 animals in the positive control groups exhibited signs of erythema (2.0 - 3.0).
No signs of erythema were observed in any of the test animals. No signs of erythema were evident in the negative control group.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No erythema or edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No erythema or edema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No erythema.
- Reading:
- other: 1st and 2nd readings
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: 1st and 2nd readings. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- other: 1st and 2nd readings
- Hours after challenge:
- 24
- Group:
- positive control
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- erythema (2.0-3.0 severity)
- Remarks on result:
- other: Reading: other: 1st and 2nd readings. . Hours after challenge: 24.0. Group: positive control. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: erythema (2.0-3.0 severity).
Any other information on results incl. tables
Positive Control
Observation/Scores for Erythema and Edema
Animal # |
24 h 7/17/92) |
48 h |
21 |
2.0 |
2.0 |
22 |
2.0 |
3.0 |
23 |
3.0 |
3.0 |
24 |
3.0 |
3.0 |
Combined |
Incidence |
= |
4/4 = |
100% |
||
Combined |
Severity |
(24 |
hr.) |
= 10/4 |
= |
2.50 |
Combined |
Severity |
(48 |
hr.) |
= 11/4 |
= |
2.75 |
Test Group
Erythema and Edema
Animal |
24 h (07/17/92) |
48 h (07/18/92) |
1 |
0.0 |
0.0 |
2 |
0.0 |
0.0 |
3 |
0.0 |
0.0 |
4 |
0.0 |
0.0 |
5 |
0.0 |
0.0 |
6 |
0.0 |
0.0 |
7 |
0.0 |
0.0 |
8 |
0.0 |
0.0 |
9 |
0.0 |
0.0 |
10 |
0.0 |
0.0 |
Combined |
Incidence |
= |
0/10 |
= |
0% |
||
Combined |
Severity |
(24 |
hr.) |
= |
0/10 |
= |
0.0 |
Combined |
Severity |
(48 |
hr.) |
= |
0/10 |
= |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study (Buehler closed patch test in guinea pigs), the test substance (50% concentration) is not considered a skin sensitizer. No signs of erythema or edema were observed in treated animals.
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