Registration Dossier
Registration Dossier
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EC number: 239-590-1 | CAS number: 15541-60-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 June 2004 to 14 April 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Huntingdon Life Sciences, Eye Research Centre, Eye, Suffolk, IP23 7PX, UK
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine
- EC Number:
- 239-590-1
- EC Name:
- Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine
- Cas Number:
- 15541-60-3
- Molecular formula:
- C3H6N6.xH4O7P2
- IUPAC Name:
- diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): MPP
- Appearance: white powder
- Analytical purity: 98.9%
- Lot/batch No.: 10184
- Storage conditions: room temperature, dry
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: reputable laboratory animal supplier
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: suspended cages
- Diet: certified rabbit diet, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 light / 12 hours dark
IN-LIFE DATES: From: 1 March 2005 To: 4 March 2005
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5g
- Concentration (if solution): moistened with 0.5ml water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: on the back of each animal
- % coverage: not reported
- Type of wrap if used: elasticated corset
REMOVAL OF TEST SUBSTANCE
- Washing: residual material was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema and Eschar formation: scale of 1-4 (1 = no erythema; 4 = severe erythema/eschar formation
Oedema formation: scale of 1-4 (1= no oedema; 4= severe oedema)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Individual skin reactions
Skin Reaction |
Observation Time |
Individual Scores-Rabbit Number and Sex |
Total |
||
Male 1 |
Male 2 |
Male 3 |
|||
Erythema/Eschar |
1 Hour |
0 |
0 |
0 |
(0) |
24 Hours |
0 |
0 |
0 |
0 |
|
Formation |
48 Hours |
0 |
0 |
0 |
(0) |
72 Hours |
0 |
0 |
0 |
0 |
|
Oedema Formation |
1 Hour |
0 |
0 |
0 |
(0) |
24 Hours |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
(0) |
|
72 Hours |
0 |
0 |
0 |
0 |
|
Sum of 24 and 72-hour Readings (S) 0 |
|||||
Primary Irritation Index (S/6) 0/6 = 0.0 |
|||||
Classification NON-IRRITANT |
|||||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No evidence of skin irritation was noted in the study.
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