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EC number: 237-997-9 | CAS number: 14154-09-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 July - 15 August 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992-07-17
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The data requirements as laid down in the REACH regulation Annex VII, foresee “the murine local lymph node assay (LLNA) as the first choice method for in vivo testing. Only in exceptional circumstances should another test be used. Justification for the use of another in vivo test (e.g. Guinea pig maximisation test (GPMT)) shall be provided.
The poor solubility (see water solubility) and the granulometry of the test item manganese phosphate, topical application to the mouse ear was difficult to achieve. Due to the difficult feasibility of the LLNA assay, it was decided to perform the GPMT assay, which allows to assess the skin sensitising properties of difficult to test substances.
Test material
- Reference substance name:
- Trimanganese bis(orthophosphate)
- EC Number:
- 237-997-9
- EC Name:
- Trimanganese bis(orthophosphate)
- Cas Number:
- 14154-09-7
- Molecular formula:
- Mn3O8P2
- IUPAC Name:
- trimanganese bis(orthophosphate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical state: pink solid powder
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature 15 - 25 °C
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 300.7-358.3 g
- Housing: test animals were housed in groups of up to ten.
- Diet: commercial feeding mixture (Mühle Knull, Rostock, Germany), ad libitum
- Water: tap water (drinking quality, supplemented with 1 g/L vitamin C), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 16
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.5 % of the test item
- Day(s)/duration:
- day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 100% of the test item
- Day(s)/duration:
- Day 7 (duration 48 hours)
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 100 % of the test item
- Day(s)/duration:
- Day 21 (duration: 24 hours)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 (negative control)
10 (test group) - Details on study design:
- RANGE FINDING TESTS:
The appropriate test material concentrations for intradermal and epicutaneous induction and epicutaneous challenge exposures were determined in a preliminary test using 6 additional FCA-treated animals.
For intradermal exposure, animals were given the test material at 5, 2.5, 1 and 0.5% suspensions in water by intradermal injections (0.1 mL). Animals were examined for signs of skin irritation at 24 and 48 h post-injection according to the Magnusson and Kligman grading scale.
For topical exposure, animals were treated with the test material at 100, 50 and 25% in distilled water for 24 h under occlusive conditions. Irritation responses were assessed at 24 and 48 h after patch and substance removal.
Based on the results of the preliminary test (see Table 1), in the main test, 0.5% test material in water and 100% test material moistened with water were selected for intradermal and topical treatment, respectively.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections 0.1 mL)
Injection 1: 1:1 mixture (v/v) FCA/water
Injection 2: 0.5% test substance in water
Injection 3: 0.5% test substance in a 1:1 mixture (v/v) FCA/water
- Negative control group:
Intradermal (3 pairs of injections, each 0.1 mL)
Injection 1: 1:1 mixture (v/v) FCA/water
Injection 2: water
Injection 3: 1:1 mixture (v/v) FCA/water
Epicutaneous:
Test group: test substance at 100%
Negative control: water
- Site: scapular region (intradermal + epicutaneous)
- Frequency of applications: single
- Duration: Days 0-8 (on Day 6, one day prior to epicutaneous induction, the shorn skin of all animals in each group was treated with 0.5 mL of 10% sodium lauryl sulphate vaseline, in order to create a local irritation).
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (challenge)
- Day(s) of challenge: 21 (challenge)
- Exposure period: 24 h
- Test groups: 100% test substance moistened with water
- Control group: 100% test substance moistened with water
- Site: flank region
- Concentrations: 100%
- Evaluation (hr after challenge): 48 and 72 h - Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic acid (CAS No 101-86-0, routinely evaluated every 6 month at challenge concentrations of 55% in vaseline)
Results and discussion
- Positive control results:
- Hexyl cinnamic acid (at challenge concentration of 55% in vaseline) induced skin sensitisation reactions in 90% of the treated animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% of the test item
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No skin reactions were noted. All animals showed the expected body weight development. The animals did not show any visible clinical symptoms over the period of observation.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% of the test item
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No skin reactions were noted. All animals showed the expected body weight development. The animals did not show any visible clinical symptoms over the period of observation.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% of the test item
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reactions were noted. All animals showed the expected body weight development. The animals did not show any visible clinical symptoms over the period of observation.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% of the test item
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reactions were noted. All animals showed the expected body weight development. The animals did not show any visible clinical symptoms over the period of observation.
Any other information on results incl. tables
Animal weights
Table 3: Individual animal weights (g) at start / test end (test group)
Animal |
Test start |
Test end |
Body weight change |
1 |
315.0 |
389.5 |
74.5 |
2 |
320.6 |
401.5 |
80.9 |
3 |
306.3 |
381.9 |
75.6 |
4 |
304.6 |
378.0 |
73.4 |
5 |
346.6 |
432.8 |
86.2 |
6 |
300.8 |
392.5 |
91.7 |
7 |
323.9 |
404.2 |
80.3 |
8 |
301.5 |
361.5 |
60.0 |
9 |
301.8 |
362.9 |
61.1 |
10 |
314.3 |
389.4 |
75.1 |
Individual weight of control group
Table 4: Individual animal weights (g) at test start and at test end (control group)
Animal |
Test start |
Test end |
Body weight change |
K1 |
300.7 |
376.2 |
75.5 |
K2 |
309.3 |
381.7 |
72.4 |
K3 |
358.3 |
420.8 |
62.6 |
K4 |
328.2 |
405.9 |
77.7 |
K5 |
339.4 |
418.4 |
79.0 |
Table 5: Skin reactions of test animals after treatment with the test material
Animal |
Numerical grading after |
|
24 h |
48 h |
|
1 |
0 |
0 |
2 |
0 |
0 |
3 |
0 |
0 |
4 |
0 |
0 |
5 |
0 |
0 |
6 |
0 |
0 |
7 |
0 |
0 |
8 |
0 |
0 |
9 |
0 |
0 |
10 |
0 |
0 |
Table 6: Skin reactions of control animals after treatment with the test material
Animal |
Numerical grading after |
|
24h |
48h |
|
K1 |
0 |
0 |
K2 |
0 |
0 |
K3 |
0 |
0 |
K4 |
0 |
0 |
K5 |
0 |
0 |
Table 7: Skin reactions of animals after challenge treatment with HCA 55 % in vaseline
Animal |
Numerical grading after |
|
24 h |
48 h |
|
1 |
1 |
1 |
2 |
0 |
0 |
3 |
1-2 |
1-2 |
4 |
1 |
1 |
5 |
1-2 |
2 |
6 |
1 |
1 |
7 |
1-2 |
1-2 |
8 |
0-1 |
1 |
9 |
1-2 |
1 |
10 |
1 |
1 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not a skin sensitiser.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin sensitiser.
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