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EC number: 305-403-8 | CAS number: 94534-99-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- non-radioactive version
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Ammonium [trisulphamoyl-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-)
- EC Number:
- 305-403-8
- EC Name:
- Ammonium [trisulphamoyl-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-)
- Cas Number:
- 94534-99-3
- Molecular formula:
- C32H18CuN11O9S4.H4N
- IUPAC Name:
- Ammonium [trisulphamoyl-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-)
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
- Reference substance name:
- Urea
- EC Number:
- 200-315-5
- EC Name:
- Urea
- Test material form:
- liquid
- Details on test material:
- Name of the test substance used in the study report: Basacid Blau 762 fluessig
Aqueous formulation, content of dye: 19%
Constituent 1
Constituent 2
Constituent 3
- Specific details on test material used for the study:
- Composition:
19% CAS 94543-99-3
72% Water
8% Urea
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Age at the beginning of the study: about 8 weeks
Body weight range at day 0: 18.5 g - 22.2 g
The single housed animais were identif led by cage cards.
The animals were housed in fully air-conditioned rooms in which a central air-conditioning system ensured a temperature in the range of 20 - 24°C and a relative humidity in the range of 30 - 70%. The day/night rhythm was 12 h light and 12 h darkness.
Single housing in Makrolon type I cages.
Bedding: Granulat Typ 3/4 (staubfrei); SSNIFF
Type of diet: Kliba Labordiaet (Ratte-Maus-Hamster Haltungsdiaet), Provimi Kliba SA, Kaiseraugst, Switzerland ad libitum
Watering: Tap water ad libitum
Acclimatization period: At least 8 days before the first test substance application
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Remarks:
- for the high dose, the test material was used in the pure form.
- Concentration:
- Undiluted or 10% or 30% in propylene glycol
Each test animal was applied with 25 uL per ear of the respective test substance / test substance preparation to the dorsum of both ears for three consecutive days. The control group was treated with 25 uL per ear of the vehiole alone.
19% is the solubility limit. Higher concentrations are not possible. - No. of animals per dose:
- 6
- Details on study design:
- The test substance preparations were produced on a weight by weight (wlw) basis shortly before the application by stirring with a magnetic stirrer.
The homogeneity of the test substance preparations during application was provided by stirring with a magnetic stirrer.
Form of test substance preparations: The test substance was applied undiluted resp. as an emulsion for all applications. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks:
- Cell count
- Value:
- 1.11
- Test group / Remarks:
- 10% in propylene glycol (1.9% of the substance)
- Parameter:
- SI
- Remarks:
- cell count
- Value:
- 0.97
- Test group / Remarks:
- 30% in propylene glycol (5.7% of the substance)
- Parameter:
- SI
- Remarks:
- cell count
- Value:
- 1.07
- Test group / Remarks:
- undiluted (19% of the test substance)
- Parameter:
- SI
- Remarks:
- Lymph node weight
- Value:
- 1.08
- Test group / Remarks:
- 10% in propylene glycol
- Parameter:
- SI
- Remarks:
- Lymph node weight
- Value:
- 1.17
- Test group / Remarks:
- 30% in propylene glycol
- Parameter:
- SI
- Remarks:
- Lymph node weight
- Value:
- 1.15
- Test group / Remarks:
- Undiluted (19% of the test substance)
Any other information on results incl. tables
Table 1: Individual values for the lymph node weights
| Test Group | Animal No. | Lymph Node Weight [mg] | ||
| Individual | Mean | S.D. | ||
| 1 | 4.0 | |||
| 2 | 4.2 | |||
| 1 vehicle propylene glycol |
3 | 5.3 | 4.6 | 0.6 |
| 4 | 5 | |||
| 5 | 4.9 | |||
| 6 | 4.0 | |||
| 7 | 4.3 | |||
| 8 | 4.0 | |||
| 2 10% in propylene glycol |
9 |
5.8 |
5.0 | 0.7 |
| 10 | 5 | |||
| 11 | 5.5 | |||
| 12 | 5.1 | |||
| 13 | 5.3 | |||
| 14 | 4.3 | |||
| 3 30% in propylene glycol |
15 | 6.0 |
5.3 | 0.6 |
| 16 | 5.3 | |||
| 17 | 5.3 | |||
| 18 | 5.8 | |||
| 19 | 6.5 | |||
| 20 | 5.5 | |||
| 4 undiluted |
21 |
4.2 |
5.2 | 0.9 |
| 22 | 4.7 | |||
| 23 | 5.8 | |||
| 24 | 4.7 | |||
Table 2: Individual counts for the cell counts
| Test Group | Animal No. | Cell Count [Count/Lymph Node Pair] | ||
| Individual | Mean | s.d. | ||
| 1 | 7'062'000 | |||
| 2 | 8'380'000 | |||
| 1 vehicle propylene glycol |
3 | 9,538,000 |
7'968'333 | 1'179'450 |
| 4 | 8,524,000 | |||
| 5 | 8'118'000 | |||
| 6 | 6'188'000 | |||
| 7 | 6'646'000 | |||
| 8 | 6'160'000 | |||
| 2 10% in propylene glycol |
9 | 10,930,000 |
8'858'667 | 1'994'323 |
| 10 | 9,316,000 | |||
| 11 | 10'480'000 | |||
| 12 | 9'620'000 | |||
| 13 | 9'442'000 | |||
| 14 | 4'699'000 | |||
| 3 30% in propylene glycol |
15 |
7,558,000 |
7'733'500 | 1'695'198 |
| 16 | 7,760,000 | |||
| 17 | 7'722'000 | |||
| 18 | 9'220'000 | |||
| 19 | 12'858'000 | |||
| 20 | 7'420'000 | |||
| 4 undiluted |
21 |
6,826,000 |
8'506'000 | 2'390'135 |
| 22 | 6,246,000 | |||
| 23 | 9'222'000 | |||
| 24 | 8'464'000 | |||
s.d. = standard deviation
Table 3: Ear weights
| Test Group | Treatment | Mean | S.D. | Index |
| 1 | vehicle propylene glycol | 27.4 | 0.9 | 1.00 |
| 2 | 10% in propylene glycol | 27.6 | 0.5 | 1.01 |
| 3 | 30% in propylene glycol | 28.4 | 1.7 | 1.04 |
| 4 | undiluted | 27.9 | 1.3 | 1.02 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No signs of systemic toxicity were noticed. The test material (19% aquaeous formulation) did not induce a statistically significant and biologicaily relevant response of the auricular Iymph nodes when applied as 10% preparation in propylene glycol or applied as the undiluted test substance. The statisticaliy significant increase in lymph node weights of mice treated with the 30% test material preparation was not in congruency with the ceIl counts, which were not statisticaily significant at all concentrations. The ear weights did not indicate a significant Irritation of the ear skin by the test substance.
From the results of the study it is concluded, that the 19% aquaeous formulation does not have a skin sensitizing effect in the Murine Local Lymph Node Assay.
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