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EC number: 700-941-3 | CAS number: 1512859-54-9
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Cuprate(4-), [2-[[4-chloro-6-[ethyl[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-5-(hydroxy-kO)-6-[2-[2-[2-[2-(hydroxy-kO)-5-sulfophenyl]diazenyl-kN1]-4,5-dimethoxyphenyl]diazenyl-kN2]-1,7-naphthalenedisulfonato(6-)]-, hydrogen sodium (1:2:2)
- EC Number:
- 700-941-3
- Cas Number:
- 1512859-54-9
- Molecular formula:
- C37H28ClCuN9O19S5 . 2 Na . 2 H
- IUPAC Name:
- Cuprate(4-), [2-[[4-chloro-6-[ethyl[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-5-(hydroxy-kO)-6-[2-[2-[2-[2-(hydroxy-kO)-5-sulfophenyl]diazenyl-kN1]-4,5-dimethoxyphenyl]diazenyl-kN2]-1,7-naphthalenedisulfonato(6-)]-, hydrogen sodium (1:2:2)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Intradermal injection induction : the 2.5% (w/v) concentration of test article was used
Topical induction : 50% (w/v) concentration of test article was used
Challenge exposure : 10% (w/v) concentration of test article was used
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Intradermal injection induction : the 2.5% (w/v) concentration of test article was used
Topical induction : 50% (w/v) concentration of test article was used
Challenge exposure : 10% (w/v) concentration of test article was used
- Positive control substance(s):
- yes
- Remarks:
- α-hexylcinnamaldehyde
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Details on study design:
- Species: Mouse, CBA strain, inbred, SPF-Quality.
Recognized by the international guidelines as the recommended test system (e.g. OECD, EC, EPA).
Source: Charles River France, L'Arbresle Cedex, France
Number of animals: 20 females (nulliparous and non-pregnant), five females per group.
In the main study, three groups of five experimental animals were treated with test substance concentrations of 5%, 25% or 50% on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (Dimethyl sulphoxide).
Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised.
After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of Disintegrations Per Minute (DPM) and a stimulation index was subsequently calculated for each group. - Positive control substance(s):
- other: Dimethyl Sulfoxide
Results and discussion
- Positive control results:
- The latest results showed that positive control animals had shown skin reactions of 1 and the sensitization rate of HCA was 80%.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 6.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 9.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 5%. No with. + reactions: 2.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 5%. No with. + reactions: 3.0. Total no. in groups: 5.0.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The SI values calculated for the substance concentrations 5, 25 and 50% were 9.4, 8.9 and 12.9 respectively. These results show that the test substance elicits an SI >= 3. The EC3 value was established to be between 0 and 5%.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The DPM values calculated for the substance concentrations 5, 25 and 50% were 4038, 3835 and 5550 respectively.
Any other information on results incl. tables
| Skin Examination Data | |||||
| Group | Animal ID | Scores after challenge | Sensitization | ||
| 24 hours | 48 hours | (score > 1 within 48 hour) | |||
| Control | 3120040038 | 0 | 0 | ― | |
| 3120040039 | 1 | 1 | ― | ||
| 3120040040 | 0 | 0 | ― | ||
| 3120040041 | 0 | 0 | ― | ||
| 3120040042 | 0 | 1 | ― | ||
| Treated | 3120040043 | 1 | 1 | No | |
| 3120040046 | 0 | 1 | No | ||
| 3120040048 | 1 | 1 | No | ||
| 3120040049 | 1 | 0 | No | ||
| 3120040050 | 0 | 1 | No | ||
| 3120040051 | 0 | 1 | No | ||
| 3120040054 | 1 | 1 | No | ||
| 3120040056 | 0 | 2 | Yes | ||
| 3120040058 | 1 | 1 | No | ||
| 3120040059 | 1 | 2 | Yes | ||
| Sensitization rate (%) | 20 | ||||
| Sensitization classification | Mild sensitizer | ||||
| ―: not available | |||||
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- There were no systemic adverse effects including effects on clinical signs of toxicity and body weight observed in all animals. During the 48 hours
after challenge exposure, two of ten treated animals showed sensitive to the test article. The sensitization rate was 20%.
The substance is classified as a "mild sensitizer" as defined by the sensitization classification system.
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