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Registration Dossier
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EC number: 308-114-5 | CAS number: 97862-65-2
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:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
- EC Number:
- 308-114-5
- EC Name:
- Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
- Cas Number:
- 97862-65-2
- Molecular formula:
- C40H28CrN8O10S2.C28H31N2O3.C20H32N
- IUPAC Name:
- Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
- Test material form:
- solid: particulate/powder
- Details on test material:
- Physical state / color: red, solid
Storage conditions: at room temperature in the dark
Batch: 001-141502
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V.,lnc ., Postbus 6174, 5960 AD Horst, The Netherlands
- Females (if applicable) nulliparous and non-pregnant:yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: Ca. 15 - 25 g
- Housing: single cages
- Diet (e.g. ad libitum): ad libtum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 15 Nov 2016 To: 5 Dec 2016 (main study) (Pre-tests for dose-selection and vehicle selection were performed before the main study)
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 1, 2.5 and 5%
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: The substance is generally of poor solubility. In DMF, a homogeneous suspension could be achieved.
- Irritation: Concentrations exceeding 5% im DMF were irritating to the skin of mice ears.
- Systemic toxicity:
- Ear thickness measurements:
- Erythema scores:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:3H-Thymidine incorporation
- Criteria used to consider a positive response: SI > 3
TREATMENT PREPARATION AND ADMINISTRATION: Test substance was weighed and mixed with the vehicle shortly before treatment. Homogeneity was achieved by stirring with a magnetic stirrer.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.52
- Test group / Remarks:
- 1%
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 2.5%
- Parameter:
- SI
- Value:
- 1.41
- Test group / Remarks:
- 5%
- Parameter:
- EC3
- Remarks on result:
- not determinable
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
See table 2
DETAILS ON STIMULATION INDEX CALCULATION
EC3 CALCULATION
An EC3 could not be calculated because there was no dose-dependent increase and no values above 3.
CLINICAL OBSERVATIONS:
BODY WEIGHTS
See table 4
Any other information on results incl. tables
Table 1: 3H-Thymidine incorporation
| DPM / lymph node pair | S.D. | Stimulation Index | |
| vehicle DMF | 982.9 | 232.8 | 1.00 |
| 1% in DMF | 1493.9 | 331.5 | 1.52 |
| 2.5% in DMF | 1184.0 | 384.2 | 1.20 |
| 5% in DMF | 1389.7 | 167.8 | 1.41 |
Table 2: Cell counts
| Mean [Counts / lymph node pair] |
S.D. | Stimulation Index | |
| vehicle DMF | 11'946'000 | 1'401'690 | 1.00 |
| 1% in DMF | 14'852'400 | 3'134'248 | 1.24 |
| 2.5% in DMF | 13'856'400 | 2'179'411 | 1.16 |
| 5% in DMF | 14'186'400 | 2'122'103 | 1.19 |
Table 3: Lymph node weights
| Mean [mg] | S.D. | Stimulation Index | |
| vehicle DMF | 5.2 | 0.5 | 1.00 |
| 1% in DMF | 5.7 | 0.9 | 1.08 |
| 2.5% in DMF | 5.5 | 0.7 | 1.06 |
| 5% in DMF | 5.6 | 0.9 | 1.07 |
Table 4: Body weights
| Mean Weight d0 | S.D. | Mean Weight d5 | S.D. | |
| vehicle DMF | 19.8 | 1.1 | 20.7 | 1.2 |
| 1% in DMF | 19.3 | 0.7 | 20.2 | 0.8 |
| 2.5% in DMF | 19.7 | 0.5 | 20.7 | 0.5 |
| 5% in DMF | 18.8 | 1.1 | 19.8 | 1.2 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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