Registration Dossier
Registration Dossier
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EC number: 218-817-8 | CAS number: 2243-62-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 1,5-naphthylenediamine
- EC Number:
- 218-817-8
- EC Name:
- 1,5-naphthylenediamine
- Cas Number:
- 2243-62-1
- Molecular formula:
- C10H10N2
- IUPAC Name:
- 1,5-naphthylenediamine
- Details on test material:
- IUCLID4 Test substance: other TS: purity 98.4 %
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: DHPW
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Cremophor (EL 2%)
- Concentration / amount:
- Intradermal induction: 2,5%
Topical induction: 50%
1. Provocation: 50%
2. Provocation: 5% and 25%
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: Cremophor (EL 2%)
- Concentration / amount:
- Intradermal induction: 2,5%
Topical induction: 50%
1. Provocation: 50%
2. Provocation: 5% and 25%
- No. of animals per dose:
- 20- Test substance groups
10- Control groups - Details on study design:
- The animals in the 3 groups were treated as follows:
a) Test substance group:
1. cranial pair of intradermal injections: Freud´s complete adjuvant (Difco Lab.) 1:1 with sterile physiological saline.
2. medial pair of intradermal injections: 1,5-Naphthylendiamin 2,5% in Cremophor EL (2% v/v) in sterile, physiological NaCl-solution.
3. caudal pair of intradermal injections: 1,5-Naphthylendiamin 2,5% in Cremophor EL (2% v/v) in sterile, physiological NaCl-solution and Freud´s
complete adjuvant (half and half).
b) Control groups
The animals of the control groups were treated the same way as the test substance groups, however no test substance was added to the medial
and caudal pairs of intradermal injections.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- Slight to medium reddening
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: Slight to medium reddening.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- Slight to medium reddening
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: Slight to medium reddening.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- Slight to medium reddening
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: Slight to medium reddening.
Any other information on results incl. tables
No. of animals with sensitized skin after 48 hours after provocation:
| Test substance group (20 animals) | 1., respectively 2. control group (10 animals respectively) | |||
| Test substance patch | Control patch | Test substance patch | Control patch | |
| 1.Provocation 50% | 9 | 0 | 0 | 0 |
| 2.Provocation 25% | 10 | 0 | 0 | 0 |
| 5% | 4 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Classification: sensitizing
- Executive summary:
Male guinea pigs were tested with the Maximisation test (MAGNUSSON and KLINGMAN).
The test was executed with following concentrations of the test substance:
Intradermal Induction: 2,5%
Topical Induction: 50%
1. Provokation: 50%
2. Provokation: 5% and 25 %
The test substance was formulated with Cremophor EL (2% v/v) in sterile, physiological NaCl-solution.
After the 1. provocation in 9 of 20 animals an obvious skin sensitization was observed with 50% test substance-formulation.
After the 2. provocation with the 25% test substance-formulation in 10 animals and with the 5% test substance-formulation in 4 animals a skin sensitization was observed.
The test substance was found to be sensitizing to the skin.
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