Registration Dossier
Registration Dossier
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EC number: 620-216-4 | CAS number: 298692-41-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-12-02 - 2003-03-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- isopropyl (diaminophosphoryl) carbamate
- Cas Number:
- 298692-41-8
- Molecular formula:
- C4H12N3O3P
- IUPAC Name:
- isopropyl (diaminophosphoryl) carbamate
- Reference substance name:
- Carbamic acid, (diaminophosphinyl)-1-methylethylester
- IUPAC Name:
- Carbamic acid, (diaminophosphinyl)-1-methylethylester
- Details on test material:
- Purity: > 95 %
Batch no.: P204/98/S-2
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: aqua pro injectione
- Concentration / amount:
- induction by intracutaneous injection:
injection 1: mixture of aqua pro injectione and Freund's Complete Adjuvant 1:1
injection 2: 5 % solution of test item in aqua pro injectione
injection 3: 5 % solution of test item in aquapro injectione/Freund's Complete Adjuvans 1:1
induction by epicutaneous administration:
0.5 g of the 25 % mixture of test item with vaseline
challenge by epicutaneous administration:
0.5 g of the 25 % mixture of test item with vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: aqua pro injectione
- Concentration / amount:
- induction by intracutaneous injection:
injection 1: mixture of aqua pro injectione and Freund's Complete Adjuvant 1:1
injection 2: 5 % solution of test item in aqua pro injectione
injection 3: 5 % solution of test item in aquapro injectione/Freund's Complete Adjuvans 1:1
induction by epicutaneous administration:
0.5 g of the 25 % mixture of test item with vaseline
challenge by epicutaneous administration:
0.5 g of the 25 % mixture of test item with vaseline
- No. of animals per dose:
- 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % (w/w). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 % (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25 % (w/w). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- No clinical signs were observed in the course of testing. The body weights and the body weight gain were not affected by the treatment. The intracutaneous injection of the 5 % solution of the test item in aqua pro injectione did not cause any skin reaction. In combination with sensitisation potentiating FCA slight to moderate erythema and oedema were observed. The epicutaneous administration of 25 % mixture of the test item with vaseline did not cause any irritation. The challenge with the 25 % mixture of the test item with vaseline did not cause any irritation signs in all animals. The test item is not to classify as skin sensitiser.
- Executive summary:
No clinical signs were observed in the course of testing. The body weights and the body weight gain were not affected by the treatment. The intracutaneous injection of the 5 % solution of the test item in aqua pro injectione did not cause any skin reaction. In combination with sensitisation potentiating FCA slight to moderate erythema and oedema were observed. The epicutaneous administration of 25 % mixture of the test item with vaseline did not cause any irritation. The challenge with the 25 % mixture of the test item with vaseline did not cause any irritation signs in all animals. The test item is not to classify as skin sensitiser.
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