Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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
Toxicological information
Skin sensitisation
Currently viewing:
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
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.
