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EC number: 230-258-1 | CAS number: 6992-11-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- DEC 2004 to 25 JAN 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 429) performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- due to technical reasons only one lymph node could be analysed for one animal
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-[(2,5-dichlorophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxynaphthalene-2-carboxamide
- EC Number:
- 230-258-1
- EC Name:
- 4-[(2,5-dichlorophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxynaphthalene-2-carboxamide
- Cas Number:
- 6992-11-6
- Molecular formula:
- C24H15Cl2N5O3
- IUPAC Name:
- 4-[(1E)-2-(2,5-dichlorophenyl)diazen-1-yl]-3-hydroxy-N-(2-oxo-2,3-dihydro-1H-1,3-benzodiazol-5-yl)naphthalene-2-carboxamide
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands BV, Horst, The Netherlands
- Age at study initiation: 8-12 weeks
- Housing: Individually in Macrolon Type I cages with wire mesh top and granulated sooft wood bedding
- Diet: Pelleted standard diet (provided by Harlan Winkelmann GmbH, Borchen, Germany); ad libitum
- Water: Community tap water from Rossdorf, ad libitum
- Acclimation period: yes, but duration not mentioned
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 3.75, 7.5, and 15 % (w/v)
- No. of animals per dose:
- 5 females per dose group
2 females in the pre-test - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: acetone/olive oil (4:1) was selected as solvent because it was the most suitable solvent
- 15% (w/v) was the highest technically applicable concentration
- Irritation: no signs of systemic toxicity after single application of test item concentration of 15% (w/v). Due to the intense brown colour of the test item local irritation reactions such as ear redness could not be detected. No swelling of the ears was observed.
- Lymph node proliferation response: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response:
1: exposure to at least one concentration of the test item resulted in an incorporation of 3H-methyl thymidine at least 3-fold or greater than that recorded in control mice as indicated by the stimulation index
2: data are compatible with a conventional dose response, although allowance must be made for either local toxicity or immunological suppression
TREATMENT PREPARATION AND ADMINISTRATION:
- individual preparation of weight volume dilutions using a magnetic stirrer as homogenizer
- test item preparations were made feshly before each dosing occasion
- 25 µl were spread over the entire dorsal surface of each ear lobe once daily for three consecutive days - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- - calculations of mean values and standard deviations for body weight
- A statistical analysis was conducted for assessment of the dose-response relationship, and the EC3 value was calculated according to the equation EC3 = (a-c) [(3-d)/(b-d)] + c; where EC3 is the estimated concentration of the test item required to produce a 3-fold increase in draining Iymph node cell proliferative activity; (a, b) and (c, d) are respectively the co-ordinates of the two pair of data lying immediately above and below the value of 3 on the local lymph node assay dose response Plot.
- The Dunnett-test (ANOVA) was conducted to assess whether the difference is statistically significant between test item groups and negative control (vehicle) group. Statistical significance was at the five per cent level (p < 0.05).
Results and discussion
- Positive control results:
- Stimulation indices of 2.0, 3.0 and 4.9 were determined with the positive control item at concentrations of 5%, 10% and 25% (w/v), respectively, in acetone:olive oil, 4:1 (v/v). An EC3 value was calculated (= 9.9% (w/v)).
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- CG 1_5
- Remarks on result:
- other: Stimulation indices (SI) were all below 3. The following SI were calculated: 3.75% test item: 1.35 7.5% test item: 0.73 15% test item: 0.79
- Parameter:
- SI
- Value:
- 1.35
- Test group / Remarks:
- TG 2_5
- Remarks on result:
- other: Stimulation indices (SI) were all below 3. The following SI were calculated: 3.75% test item: 1.35 7.5% test item: 0.73 15% test item: 0.79
- Parameter:
- SI
- Value:
- 0.73
- Test group / Remarks:
- TG 3_5
- Remarks on result:
- other: Stimulation indices (SI) were all below 3. The following SI were calculated: 3.75% test item: 1.35 7.5% test item: 0.73 15% test item: 0.79
- Parameter:
- SI
- Value:
- 0.79
- Test group / Remarks:
- TG 4_5
- Remarks on result:
- other: Stimulation indices (SI) were all below 3. The following SI were calculated: 3.75% test item: 1.35 7.5% test item: 0.73 15% test item: 0.79
Any other information on results incl. tables
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. Calculation of the EC3 value was not performed because no test concentration produced a SI of 3 or higher.
Test item |
Measurement |
Calculation |
Result |
Calculation |
DPM per lymph node b) |
Result |
|
% (w/v) |
Group |
DPM-BG |
S.I,* |
number |
S.I. |
||
--- |
BG I |
2.9 |
--- |
--- |
--- |
--- |
---- |
--- |
BG II |
3.7 |
--- |
--- |
--- |
--- |
--- |
--- |
CG 1_1 |
1905.2 |
1901.9 |
--- |
--- |
--- |
--- |
--- |
CG 1_2 |
1269.1 |
1265.8 |
--- |
--- |
--- |
--- |
--- |
CG 1_3 |
1384.1 |
1380.8 |
--- |
--- |
--- |
--- |
--- |
CG 1_4 |
1522.3 |
1519.0 |
--- |
--- |
--- |
--- |
--- |
CG 1_5 |
1667.7 |
1664.4 |
--- |
10 |
773.2 |
1.00 |
3.75 |
TG 2_1 |
1466.3 |
1463.0 |
0.9 |
--- |
--- |
--- |
3.75 |
TG 2_2 |
2294.1 |
2290.8 |
1.5 |
--- |
--- |
--- |
3.75 |
TG 2_3 |
2562.7 |
2559.4 |
1.7 |
--- |
--- |
--- |
3.75 |
TG 2_4 |
1941.8 |
1938.5 |
1.3 |
--- |
--- |
--- |
3.75 |
TG 2_5 |
1112.5 |
1109.2c) |
0.7 |
9 |
1040.1 |
1.35 |
7.5 |
TG 3_1 |
823.7 |
820.4 |
0.5 |
--- |
--- |
--- |
7.5 |
TG 3_2 |
1316.3 |
1313.0 |
0.8 |
--- |
--- |
--- |
7.5 |
TG 3_3 |
1252.3 |
1249.0 |
0.8 |
--- |
--- |
--- |
7.5 |
TG 3_4 |
984.3 |
981.0 |
0.6 |
-- |
--- |
--- |
7.5 |
TG 3_5 |
1305.8 |
1302.5 |
0.8 |
10 |
566.6 |
0.73s |
15.0 |
TG 4_1 |
1113.7 |
1110.4 |
0.7 |
--- |
--- |
--- |
15.0 |
TG 4_2 |
898.2 |
894.9 |
0.6 |
--- |
--- |
--- |
15.0 |
TG 4_3 |
1420.1 |
1416.8 |
0.9 |
--- |
--- |
--- |
15.0 |
TG 4_4 |
1352.7 |
1349.4 |
0.9 |
--- |
--- |
--- |
15.0 |
TG 4_5 |
1313.8 |
1310.5 |
0.8 |
10 |
608.2 |
0.79 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
CG = Control Group
TG = Test Group
5.1 = Stimulation Index
* = mean net DPM value per lymph node of the mouse divided by the mean net DPM value of the vehicle control group
a) =The mean of the Background value (BGI and BGH) was subtracted from the value.
b) DPM/node was determined by dividing the sum of the measured values from all lymph nodes within a group by the number of lymph nodes taken from that group
c) DPM value of one lymph node
s = Mean DPM value for the group was according to the Dunnett test significantly lower than corresponding control value. The p value for the analysis was 0.038. This is, however,irrelevant, since the significant value (0.73) is below the control value and not above.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Tested in this study according to OECD test guideline no. 429 and GLP conditions the test item was not a skin sensitiser.
- Executive summary:
In the study the test item dissolved in acetone:olive oil, 4:1 (v/v)was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay was performed using test item concentrations of 0, 3.75, 7.5 and 15 % (w/v).
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
In this study Stimulation Indices (S.l..) of 1.35, 0.73 and 0.79 were determined with the test item at concentrations of 3.75, 7.5 and 15 % (w/v) in acetone:olive oil, 4:1 (v/v), respectively,
The test item was not a skin sensitiser in this assay
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