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EC number: 202-992-2 | CAS number: 101-96-2
- 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:
- other: Acceptable, well-documented study which meets basic scientific principles.
- Justification for type of information:
- Key study, GLP, Klimisch score 2
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
- Principles of method if other than guideline:
- According to G. Klecak: Identification of Contact Allergens (Predictive Tests in Animals) in: Advances in Modern Toxicology Vol. 4, - Dermatotoxicology and Pharmacology -, ed. F. N. Marzulli, H.I. Maibach, pp. 321 - 324 (1977)
- GLP compliance:
- yes
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- The test was performed in 1984, before LLNA was selected as the first-choice test and before OECD 429 was adopted.
Test material
- Reference substance name:
- N,N'-di-sec-butyl-p-phenylenediamine
- EC Number:
- 202-992-2
- EC Name:
- N,N'-di-sec-butyl-p-phenylenediamine
- Cas Number:
- 101-96-2
- Molecular formula:
- C14H24N2
- IUPAC Name:
- N,N'-di-sec-butyl-p-phenylenediamine
- Details on test material:
- - Name of test material (as cited in study report): Kerobit BPD = N,N'-Di-sek .-butyl-p-phenylendiamin
- Physical state: red liquid
- Analytical purity: 96.92%
- Lot/batch No.: 82/175; 82/175-1
- Stability under test conditions: assured for period of study
- Storage condition of test material: under oxygen exclusion
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White, Dunkin Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co., KG, Exertal, Germany
- Weight at study initiation: mean 258 - 428 g (1. Experiment); mean 244 - 309 g (2. Experiment)
- Housing: 4 animals in Makrolon Type IV cages
- Diet: Ssniff GK 4 mm (Standard diet for rabbits and guinea pigs), ad libitum
- Water: tap water, ad libitum (2x times a week addition of 2 g ascorbic acid to 10 L water)
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- 0.1, 0.3, 1 and 3% in ethanol
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- 0.1, 0.3, 1 and 3% in ethanol
- No. of animals per dose:
- 8
- Details on study design:
- RANGE FINDING TESTS: In a pre-test 0.025 mL/cm² of 10, 3, 1 and 0.3% test substance in ethanol and conc. ethanol were applied to the skin of guinea pigs (epicutaneous open). 1% was found to be the minimal irritating concentration and 0.3% as the maximal non-irritating concentration. Readings were conducted 24, 48 and 72 hours following application.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 20
- Exposure period: 24 h epicutaneous
- Test groups:
application of vehicle (conc. ethanol)
- Control group:
application of test substance in ethanol
- Site: right flank (for the 3% solution application site was changed from cranial to caudal due to severe irritation reactions cranial)
- Frequency of applications: daily on week days
- Duration: 26 days
- Concentrations: 0.005, 0.01 (Experiment II), 0.1, 0.3, 1, 3% (Experiment I)
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 28 and 42
- Exposure period: 72 hours
- Test groups: epicutaneous challenge with 4 (experiment I), 2 (Experiment II) test substance concentrations (1. and 2. challenge)
- Control group: epicutaneous challenge with test substance (2. challenge all groups; 1. challenge one control group was challenged with ethanol)
- Site: left flank
- Concentrations: 0.005, 0.01, 0.1, 0.3, 1, 3%
- Evaluation (hr after challenge): 0.005, 0.01 (Experiment II), 0.1, 0.3, 1, 3% (Experiment I) - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1% induction, 0.3% challenge
- No. with + reactions:
- 8
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1% induction, 0.3% challenge. No with. + reactions: 8.0. Total no. in groups: 8.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3% induction, 0.3% challenge
- No. with + reactions:
- 8
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.3% induction, 0.3% challenge. No with. + reactions: 8.0. Total no. in groups: 8.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% induction, 0.3% challenge
- No. with + reactions:
- 7
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% induction, 0.3% challenge. No with. + reactions: 7.0. Total no. in groups: 8.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3% induction, 0.3% challenge
- No. with + reactions:
- 7
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3% induction, 0.3% challenge. No with. + reactions: 7.0. Total no. in groups: 8.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1% induction, 0.1% challenge
- No. with + reactions:
- 2
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1% induction, 0.1% challenge. No with. + reactions: 2.0. Total no. in groups: 8.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3% induction, 0.1% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.3% induction, 0.1% challenge. No with. + reactions: 0.0. Total no. in groups: 8.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% induction, 0.1% challenge
- No. with + reactions:
- 1
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% induction, 0.1% challenge. No with. + reactions: 1.0. Total no. in groups: 8.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3% induction, 0.1% challenge
- No. with + reactions:
- 4
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3% induction, 0.1% challenge. No with. + reactions: 4.0. Total no. in groups: 8.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.005 or 0.01% induction, 0.005 or 0.01% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- no reactions were seen for both dose groups
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.005 or 0.01% induction, 0.005 or 0.01% challenge. No with. + reactions: 0.0. Total no. in groups: 8.0. Clinical observations: no reactions were seen for both dose groups.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1% induction, 0.1% challenge
- No. with + reactions:
- 3
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1% induction, 0.1% challenge. No with. + reactions: 3.0. Total no. in groups: 8.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3% induction, 0.1% challenge
- No. with + reactions:
- 5
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.3% induction, 0.1% challenge. No with. + reactions: 5.0. Total no. in groups: 8.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% induction, 0.1% challenge
- No. with + reactions:
- 5
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% induction, 0.1% challenge. No with. + reactions: 5.0. Total no. in groups: 8.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3% induction, 0.1% challenge
- No. with + reactions:
- 5
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3% induction, 0.1% challenge. No with. + reactions: 5.0. Total no. in groups: 8.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.005 or 0.01% induction, 0.005 or 0.01% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- no reactions were seen for both dose groups
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.005 or 0.01% induction, 0.005 or 0.01% challenge. No with. + reactions: 0.0. Total no. in groups: 8.0. Clinical observations: no reactions were seen for both dose groups.
Any other information on results incl. tables
Table 1. Results of Experiment I
|
Concentrations of |
||||||||
|
Induction |
Challenge |
Challenge |
||||||
|
|
3% |
1% |
0.3% |
0.1% |
3% |
1% |
0.3% |
0.1% |
Control 1 |
a |
8/8 |
4/8 |
0/8 |
0/8 |
8/8 |
8/8 |
4/8 |
0/8 |
Control 2 |
a |
0/8 a |
0/8 a |
0/8 a |
0/8 a |
8/8 |
7/8 |
0/8 |
0/8 |
Exp. 1 |
3% |
8/8 |
8/8 |
7/8 |
4/8 |
8/8 |
8/8 |
8/8 |
5/8 |
Exp. 2 |
1% |
8/8 |
8/8 |
7/8 |
1/8 |
8/8 |
8/8 |
8/8 |
5/8 |
Exp. 3 |
0.3% |
8/8 |
8/8 |
8/8 |
0/8 |
8/8 |
8/8 |
8/8 |
5/8 |
Exp. 4 |
0.1% |
8/8 |
8/8 |
8/8 |
2/8 |
8/8 |
8/8 |
8/8 |
3/8 |
a = Ethanol (vehicle control); x/y = no. of positive reactions/no. of application sites 48 hours after challenge
Control 2 was challenged using vehicle at first challenge
Table 2. Results of Experiment II
|
Concentrations of |
||||
|
Induction |
Challenge |
Challenge |
||
|
|
0.01% |
0.005% |
0.01% |
0.005% |
Control 1 |
a |
0/8 |
0/8 |
0/8 |
0/8 |
Control 2 |
a |
0/8 a |
0/8 a |
0/8 |
0/8 |
Exp. 1 |
0.01% |
0/8 |
0/8 |
0/8 |
0/8 |
Exp. 2 |
0.005% |
0/8 |
0/8 |
0/8 |
0/8 |
a = Ethanol (vehicle control); x/y = no. of positive reactions/no. of application sites 48 hours after challenge
Control 2 was challenged using vehicle at first challenge
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- DSD: Xi, R43
CLP: Cat. 1, H317
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