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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study OECD 402 (BASF method).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- According to BASF-internal standard. Young adult laboratory rats in groups of 5 to 10 rats per sex and dose were treated simultaneously with preparations of the test substance in suitable vehicle occlusive on the skin. Group-wise documentation of clinical signs was performed over the 7 to 14 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form. On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
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: liquid, colorless
- Analytical purity: 98%
- Lot/batch No.: 82/175
- Stability under test conditions: stable for study period
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: 12 weeks
- Weight at study initiation: 200 - 300 g
- Housing: single housing in V-II-A-Stahl cages, Type DK-III during exposure, if no skin lesions were identified group housing
- Diet: SSNIFF R, Fa. SSNIFF, Versuchstierdiaeten, Soest
- Water: tap water, ad libitum
- Acclimation period: approximately 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5 % aqueous
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 50 cm2, dorsal and dorsolateral areas of the trunk
- Type of wrap if used: inert foil
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Concentration (if solution): 10% (g/V)
- Amount(s) applied (volume or weight with unit): 3.2, 5.6, 8.3 and 12.1 ml/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 316, 562, 825 and 1210 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days - Frequency of observations and weighing: observations: several times on the day of application and at least once per working day thereafter, check of moribund and dead animals twice each working day and once on weekends and on public holidays, skin observations: 30 - 60 minutes after removal of the occlusive bandage and at least once during the observation period, body weight: before application and on days 4, 7 and 13 following application - Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 756 mg/kg bw
- 95% CL:
- 623 - 903
- Mortality:
- Male animals: 316 mg/kg bw: no deaths after 14 days; 562 mg/kg bw: 2/5 after 14 days; 825 mg/kg bw: 4/5 after 14 days; 1210 mg/kg bw: 5/5 after 14 days Female animals: 316 and 562 mg/kg bw: no deaths after 14 days; 825 mg/kg bw: 1/5 after 14 days; 1210 mg/kg bw: 5/5 after 14 days
- Clinical signs:
- other: Dyspnea, apathy, staggering, trembling (males only), poor general state (all symptoms were observed on day 1) Local signs: substance residues (day 1), deep necrosis (from day 7 to day 13), edema (from day 1 to day 13)
- Gross pathology:
- Animals that died: congestive hyperpemia; liver: partly clay-coloured peripher markings of lobules; application area: colloidal edema of the subcutis.
Sacrificed animals: nothing abnormal detected; application area: extensive necrosis, status: healing (demarcation).
Any other information on results incl. tables
Table 1. Table for acute dermal toxicity.
Dose |
Toxicological results* |
Duration of clinical signs |
Local skin effects |
Time of death |
Mortality (%) |
|
Males |
||||
316 |
0/5 |
Day 1 |
substance residues on day 1, deep necrosis (day 7 – day 13) edema (day 1 day 13) |
--- |
0 |
562 |
2/5 |
Day 1 |
substance residues on day 1, deep necrosis (day 7 – day 13) edema (day 1 day 13) |
Day 1 |
40 |
825 |
4/5 |
Day 1 |
substance residues on day 1, deep necrosis (day 7 – day 13) edema (day 1 day 13) |
Day 1 – Day 2 |
80 |
1210 |
5/5 |
Day 1 |
--- |
Day 1 |
100 |
|
Females |
||||
316 |
0/5 |
Day 1 |
substance residues on day 1, deep necrosis (day 7 – day 13) edema (day 1 day 13) |
--- |
0 |
562 |
0/5 |
Day 1 |
substance residues on day 1, deep necrosis (day 7 – day 13) edema (day 1 day 13) |
--- |
0 |
825 |
1/5 |
Day 1 |
substance residues on day 1, deep necrosis (day 7 – day 13) edema (day 1 day 13) |
Day 1 |
20 |
1210 |
5/5 |
Day 1 |
--- |
Day 1 |
100 |
|
LD50 = 756 mg/kg bw |
* first number = number of dead animals
second number = number of animals used
Applicant's summary and conclusion
- Interpretation of results:
- toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD:Xn, R21
CLP: Cat. 3, H311
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.