Registration Dossier
Registration Dossier
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EC number: 609-336-8 | CAS number: 371756-75-1
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Remarks:
- RCC, Research & Consulting Company AG
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- EC Number:
- 224-073-5
- EC Name:
- Disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- Cas Number:
- 4193-55-9
- IUPAC Name:
- disodium 5-({4-anilino-6-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)-2-{2-[4-({4-[bis(2-hydroxyethyl)amino]-6-(cyclohexa-1,3-dien-1-ylamino)-1,3,5-triazin-2-yl}amino)-2-sulfonatophenyl]vinyl}benzenesulfonate
- Details on test material:
- - Name of test material (as cited in study report): FAT 65'019/H
- Physical state: powder
- Analytical purity: 93.3%
- Lot/batch No.: ex PA. 76-79/86
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd.
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 359 to 454 g
- Housing: individually in Makrolon type-3 cages
- Diet (e.g. ad libitum): pelleted standard Kliba 342 (ad libitum)
- Water (e.g. ad libitum): community tap water (ad libitum)
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 to 70
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- Intradermal injection of test article diluted to 1%, dermal application of 15%, and dermal challenge with 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- Intradermal injection of test article diluted to 1%, dermal application of 15%, and dermal challenge with 10%
- No. of animals per dose:
- 10 animals/sex in treatment group; 5 animals/sex in control group
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Site: dorsal skin from the scapular region
- Frequency of applications: single
- Concentrations: diluted to 1%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 24 hours
- Exposure period: 24 hours
- Test groups:
- Control group:
- Site: left and right flank
- Concentrations: 10% in petrolatum oil
- Evaluation (hr after challenge): 24 and 48 hours
- Positive control substance(s):
- yes
- Remarks:
- formaldehyde solution
Study design: in vivo (LLNA)
- Statistics:
- Mean values with standard deviations. Fisher-Test (The Exact Fisher Test for comparison of the basic proability of two binominal distributions. L. Sachs, Statistische Auswertungsmethoden, Georg Thieme Verlag, Stuttgart 1971). For calculation of p-values the 24 hours reading of the animals from the control and test groups was used.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 4.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 3.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- From the results described above a mild allergenic potency of the test article diluted to 10% i n petrolatum oil was concluded after first challenge application. After second application no allergenic potency of the test article diluted to 10% in petrolatumoil was observed when the results were interpreted according to the rating of Magnusson and Kligman (1970).
According t o the EEC (European Economic Community) classification criteria described in wide lines 831467, September 16, 1983, this test article is considered to be a non-sensitizer.
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