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Registration Dossier
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EC number: 477-690-9 | CAS number: 874819-71-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-08-24 - 1004-10-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- OECD 406 (1992)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- At the time of study performance the LLNA was not the current standard test method.
Test material
- Reference substance name:
- -
- EC Number:
- 477-690-9
- EC Name:
- -
- Cas Number:
- 874819-71-3
- Molecular formula:
- Hill formula: C6H9N4O3P CAS formula: C6H9N4O3P
- IUPAC Name:
- N-(diaminophosphoryl)-2-nitroaniline
- Test material form:
- solid: crystalline
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Species/strain: Guinea-pig/Dunkin Hartley, Crl:(HA)BR
Sex: male
Supplier: Charles River Wiga GmbH, D-97320 Sulzfeld
Age: 16 days
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intracutaneous induction
- Vehicle:
- other: 0.5% solution of Tylose MH 1000 in deionised water
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Induction: i.c.: 5 % (w/v) suspesion in a 0.5 % (m/v) of Tylose in deionised water
solution of Tylose MH 1000 in
deionised water
Induction: e.c.: 25 % (w/w) mixture of the test item with
vaseline
Concentration of test material and vehicle used for each challenge:
25 % (w/w) mixture of the test item with vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.5% solution of Tylose MH 1000 in deionised water
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Induction: i.c.: 5 % (w/v) suspesion in a 0.5 % (m/v) of Tylose in deionised water
solution of Tylose MH 1000 in
deionised water
Induction: e.c.: 25 % (w/w) mixture of the test item with
vaseline
Concentration of test material and vehicle used for each challenge:
25 % (w/w) mixture of the test item with vaseline
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 10
- Total no. in group:
- 10
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 25 %
Signs of irritation during induction:
only after i.c. induction: oedema
Evidence of sensitisation of each challenge concentration:
The administration of the 25 % (w/w) mixture of the test
item with vaseline caused only a slight erythema in one of
the ten animals of the dose group on day 23.
Number of animals with skin sensitisation reaction after administration of N(2-Nitrophenyl)phosphoric triamide (left flank: control; right flank: test item) |
Test group |
Time after challenge |
|||
48hours (Day23) |
72hours (Day24) |
|||
Left flank |
Right flank |
Left flank |
Right flank |
|
Animals with skin sensitisation reaction/used animals |
||||
Control group |
0/5 |
0/5 |
0/5 |
0/5 |
Dose group |
0/10 |
1 / 10 |
0/10 |
1 / 10 |
from this |
|
|
|
|
grade 1 |
|
1/10 |
|
1 / 10 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- N-(2-Nitrophenyl)phosphoric triamide is not a skin sensitiser.
- Executive summary:
The skin sensitisation potential of the test item N-(2-Nitrophenyl)phosphoric triamide was
investigated in the Guinea-Pig Maximisation Test with the Dunkin Hartley albino strain, whose sensitivity to Benzocaine had been demonstrated, according to OECD guideline 406.
The choice of doses for the main experiment based on the results of the pilot study.
None of the animals died or showed clinical signs during the course of investigation.
The body weights and the body weight gain were not affected by the treatment.
The intracutaneous injection of the 5 % (w/v) suspension of the test item in a 0.5 % Xylose solution induced oedema. In combination with sensitisation potentiating FCA slight to moderate erythema and oedema were observed.
The epicutaneous administration of the 25 % (w/w) mixture of the test item with vaseline did not cause any irritation signs.
The challenge with the 25 % (w/w) mixture of the test item with vaseline caused only a slight erythema in one of the ten animals of the dose group.
The skin fold thickness was not affected by the challenge.
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