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EC number: 239-590-1 | CAS number: 15541-60-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 March 2005 to 20 April 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in accordance with an internationally recognised method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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 in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: reputable laboratory animal supplier
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15 - 23g
- Housing: suspended solid-floor polypropylene cages furnished with softwood woodflakes.
- Diet: certified rat and mouse food. ad libitum
- Water: mains tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: To: 21 March 13 April 2005
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Preliminary test: 25% w/w
Main test: 5, 10 and 25% w/w - No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: the maximum concentration that could be formulated in any solvent was 25% w/w. The substance was soluble at this level in the preferred solvent, 4:1 acetone/olive oil
- Irritation: observations for any irritancy were made, as well as for signs of systemic toxicity, clinical signs, bodyweight and mortality
- Lymph node proliferation response: not performed
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node assay
- Criteria used to consider a positive response: a test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentrations results in a 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.).
TREATMENT PREPARATION AND ADMINISTRATION:
The test material was freshly prepared in acetone/olive oil 4:1. This vehicle was chosen as it produced the highest concentration that was suitable for dosing.
Each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a suspension in acetone/olive oil 4:1 at concentrations of 25%, 10% or 5% w/w. A further group of four animals was treated with acetone/olive oil 4:1 alone. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Formulated in cottonseed oil:
10% v/v SI index, 1.52, negative
25% v/v SI index, 2.63, negative
50% v/v SI index, 5.07, positive
Conclusion: hexylcinnamaldehyde is a sensitiser under the conditions of the test
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.78
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 0.58
- Test group / Remarks:
- 505
Any other information on results incl. tables
Preliminary test
No signs of systemic toxicity were observed and therefore the main test was conducted at dose levels of 5, 10 and 25% w/w.
Main test
A stimulation index of less than 3 was recorded for the three concentrations of the test material (25%, 10 % and 5% w/w).
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered to be a non-sensitiser under the conditions of the test.
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