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Toxicological information

Skin sensitisation

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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:
2017
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

Constituent 1
Chemical structure
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


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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