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EC number: 276-374-6 | CAS number: 72139-17-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study is older than 12 years
Test material
- Reference substance name:
- Disodium 1-amino-4-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-2-methyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- EC Number:
- 276-374-6
- EC Name:
- Disodium 1-amino-4-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-2-methyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- Cas Number:
- 72139-17-4
- Molecular formula:
- C25H16ClF2N5O8S2.2Na
- IUPAC Name:
- disodium 1-amino-4-({3-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-methyl-5-sulfophenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Diet (ad libitum): Altromin® 3020 - Haltungsdiat fUr Meerschweinchen, Hersteller: Altromin GmbH, Lage
- Water (ad libitum): tap water
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 mL of a 5 % suspension/application
see details on study design - Day(s)/duration:
- single application
- Adequacy of induction:
- other: based on pre-test
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.5 mL of a 50 % suspension
see details on study design - Day(s)/duration:
- single application, one week after intradermal induction for 48 h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.5 mL of a 50 % suspension
- Day(s)/duration:
- Day 22 for 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 test animals, plus two control groups (10 animals each)
- Details on study design:
- RANGE FINDING TESTS:
missing in study report
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal application
- No. of exposures: 1
- Test groups:
Three pairs of intradermal injections of 0.1 ml volume were given in the shoulder region so that one of each pair lies on each side of the midline.
Injection 1 (cranial): a 1:1 mixture (v/v) FCA/ physiological saline
Injection 2 (medial): 5% suspension of the test material in physiological saline
Injection 3 (caudal): 5% suspension of the test material formulated in a 1:1 mixture (v/v) FCA/ physiological saline.
- Control group:
Three pairs of intradermal injections of 0.1 ml volume were given in the shoulder region so that one of each pair lies on each side of the midline.
Injection 1 (cranial): a 1:1 mixture (v/v) FCA/ physiological saline
Injection 2 (medial): physiological saline
Injection 3 (caudal): physiological saline in a 1:1 mixture (v/v) FCA/ physiological saline.
- Frequency of applications: 1
Epicutaneous application
- No. of exposures: 1
- Exposure period: 48 h
One day before exposure, the application sides have been clipped and painted with 0.5 mL of 10% sodium lauryl sulphate in parafine oil . A hypoallergenic band-aid (2x4 cm) impregnated with 0.5 ml the test suspension (50 % test material in physiological saline (test group) or physiological saline (control)) was put on the injection sides of the intradermal application, covered with aluminium foil and fixed for 48 h using a Fermoflex tape (Transatlantic GmbH, Schwarzenbach). At the end of the exposure period the substance was removed using physiological saline.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21 days after intradermal induction
- Exposure period: 24 h
One day before exposure, the application sides have been clipped. Two hypoallergenic band-aids (2x4 cm) impregnated with 0.5 ml the test suspension (50 % test material in physioloigical saline) was applied to the left flank of all animals (test and control group) and fixed for 24 h using a Fermoflex tape (Transatlantic GmbH, Schwarzenbach). A control band-aids impregnated with 0.5 mL physiological saline was applied to right flank of each animal in the same manor. At the end of the application sides have been chemically depilated using Pilca-Crème (Olivin GmbH, Hamburg).
- Concentration: 50 %
- Evaluation (hr after challenge): 48 and 72 h
- Scoring: The skin reaction have been scored according to Draize.
OTHER:
The body weight of all animals was recorded one day before study inition and on the las day of the study. - Challenge controls:
- 10 animals previously treated with the vehicle were challenged together with the test group using the same test article concentration as used for the test group.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- n.a.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- one animal died during the test
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- one animal died during the test
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- one animal died during test
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- one animal died during test
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs observed
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- other: not stated in the study report
Any other information on results incl. tables
Results of the main test
Clinical observations:
No clinical signs were
observed in any animal during the study, but 2 and 3 days following the
2. induction all animals of the test group had red-coloured ears. One
animal of the test groups died on day 2. Necropsy revealed a blood
filled thorax and a pale liver. The body weight development of the
remaining animals corresponded to the control group.
The individual erythema and edema scores after the challenge are shown in Table 2.
Table 2: Individual results of the 1. Challenge
| Animal Nr. | Test material concentration Erythema/Edema Score |
|||
| 0% | 50% | |||
| 48 h | 72 h | 48 h | 72 h | |
| Control group | ||||
| 1 | 0/0 | 0/0 | 0/0 | 0/0 |
| 2 | 0/0 | 0/0 | 0/0 | 0/0 |
| 3 | 0/0 | 0/0 | 0/0 | 0/0 |
| 4 | 0/0 | 0/0 | 0/0 | 0/0 |
| 5 | 0/0 | 0/0 | 0/0 | 0/0 |
| 6 | 0/0 | 0/0 | 0/0 | 0/0 |
| 7 | 0/0 | 0/0 | 0/0 | 0/0 |
| 8 | 0/0 | 0/0 | 0/0 | 0/0 |
| 9 | 0/0 | 0/0 | 0/0 | 0/0 |
| 10 | 0/0 | 0/0 | 0/0 | 0/0 |
| Test group | ||||
| 21 | 0/0 | 0/0 | 0/0 | 0/0 |
| 22 | 0/0 | 0/0 | 0/0 | 0/0 |
| 23 | 0/0 | 0/0 | 0/0 | 0/0 |
| 24 | 0/0 | 0/0 | 0/0 | 0/0 |
| 25 | 0/0 | 0/0 | 0/0 | 0/0 |
| 26 | 0/0 | 0/0 | 0/0 | 0/0 |
| 27 | 0/0 | 0/0 | 0/0 | 0/0 |
| 28 | 0/0 | 0/0 | 0/0 | 0/0 |
| 29 | 0/0 | 0/0 | 0/0 | 0/0 |
| 30 | 0/0 | 0/0 | 0/0 | 0/0 |
| 31 | 0/0 | 0/0 | 0/0 | 0/0 |
| 32 | 0/0 | 0/0 | 0/0 | 0/0 |
| 33 | 0/0 | 0/0 | 0/0 | 0/0 |
| 34 | 0/0 | 0/0 | 0/0 | 0/0 |
| 35 | 0/0 | 0/0 | 0/0 | 0/0 |
| 36 | 0/0 | 0/0 | 0/0 | 0/0 |
| 37 | 0/0 | 0/0 | 0/0 | 0/0 |
| 38 | 0/0 | 0/0 | 0/0 | 0/0 |
| 39 | 0/0 | 0/0 | 0/0 | 0/0 |
| 40 | + | + | + | + |
+ animal died during study period
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, conducted according to OECD 406, the test material can be considered as no dermal sensitiser.
- Executive summary:
In a dermal sensitization study conducted according to OECD 406 with a suspension of the test material in physiological saline, male guinea pigs were tested using the Guinea Pig Maximisation Test according to Magnusson and Kligman. Intradermal application was performed using a 5 % suspension of the test material. Epicutaneous induction was performed occlusive with a 50 % suspension for 48 h. The challenge was conducted with a 50 % suspensions of the test material for 24 h 21 days after the intradermal induction. Skin reaction was scored according to Draize. The application sides have been examined 48 and 72 h following application. No clinical sign or sign of sensitisation ware observed throughout the study, but the ears of all test group animals were coloured red 2 and 3 days after the epicutaneous application. One animal died on day two of the study. The body weight of the remaining animals developed correspondingly to the control group. Based on the results obtained in this study, the test material can be considered as not dermal sensitising.
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