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EC number: 286-839-5 | CAS number: 85391-83-9
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
- Study period:
- 16 Jan - 09 Mar 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- - Principle of test: guinea pig maximisation test with subsequent modified Buehler test (epicutaneous test)
- Short description of test conditions: first control group of maximisation test was used as test group in subsequent epicutaneous test (with additional untreated animals as control)
- Parameters analysed / observed: skin reaction - GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study predates LLNA method
Test material
- Reference substance name:
- 7-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-4-hydroxy-3-[(4-methoxy-2-sulphophenyl)azo]naphthalene-2-sulphonic acid, sodium salt
- EC Number:
- 286-839-5
- EC Name:
- 7-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-4-hydroxy-3-[(4-methoxy-2-sulphophenyl)azo]naphthalene-2-sulphonic acid, sodium salt
- Cas Number:
- 85391-83-9
- Molecular formula:
- C21H14ClF2N5O8S2.xNa
- IUPAC Name:
- 7-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-4-hydroxy-3-[(4-methoxy-2-sulphophenyl)azo]naphthalene-2-sulphonic acid, sodium salt
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Red 123
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Bor:DHPW
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 5 to 7 weeks
- Weight at study initiation: mean 325g, range 288 - 375g
- Housing: 5 animals in one makrolon cage (Type IV)
- Diet (e.g. ad libitum): Altromin 3020, ad libitum
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): ca. 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/12h
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- First induction: 2 x 3 injections: ca 0.1 mL each
1. Freund's complete adjuvant in physilogical saline (cranial)
2. 5% test item in physilogical saline (medial)
3. 5% test item in solution of physilogical saline and Freund's complete adjuvant (caudal)
control: same treatment without test item - Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Second induction: 5 mL of physiological saline with 12% test item on a patch, covered with aluminium foil for 48h
control: same treatment without test item - Day(s)/duration:
- Day 8 for 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Bühler Test: subsequent epicutaneous test with first control group of maximisation test: 12%
1. induction: 1 challenge from maximisation test: 5 mL for 24 h
2. and 3 induction: 5 mL on a patch for 6 h
7 days between the inductions - Day(s)/duration:
- Day 22 of GPMT = Day 1 Bühler Test for 24 h; Day 8 and 22 Bühler Test for 6 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.5mL of physiological saline with 12% test item on a patch
- Day(s)/duration:
- Day 22 for 24h
- Adequacy of challenge:
- other: concentration proved to be irritating in challenge
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.5 mL of physiological saline with 6 % test item on a patch
- Day(s)/duration:
- Day 29 for 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Bühler Test: 6% and 9% at 0.5 mL
- Day(s)/duration:
- Day 36 for 6 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- maximisation test: 20 per dose, 10 per control
epicutaneous test: 10 per dose, 10 per control - Details on study design:
- MAXIMISATION TEST
A. INDUCTION EXPOSURE
- No. of exposures: two (one intradermal, one epicutaneous)
- Exposure period: epicutaneous induction one week after intradermal induction
- Site: intradermal injections each one cranial, medial and caudal; epicutaneous induction on skin area of injections
- Concentrations: intradermal injections with 0.1mL physilogical saline with 5% test iteml; epicutaneous induction with 0.5mL of physiological saline with 12% test item on a patch
B. CHALLENGE EXPOSURE
- No. of exposures: two
- Day(s) of challenge: 3 and 4 weeks after intradermal induction
- Exposure period: 24h
- Site: left
- Concentrations: first challenge: 12%; second challenge: 6%
- Evaluation (hr after challenge): 48 and 72h after application
EPICUTANEOUS TEST
A. INDUCTION EXPOSURE
- No. of exposures: three (epicutaneous)
- Exposure period: epicutaneous inductions in interval of one week
- Exposure period: first: 24h, second and third: 6h
- Site: left
- Concentrations: 0.5mL of physiological saline with 12% test item on a patch
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 2 weeks after last induction
- Exposure period: 6h
- Site: left
- Concentrations: 6 and 9% test item
- Evaluation (h after challenge): 24, 48 and 72h after application - Positive control substance(s):
- not specified
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:
- 12%
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Remarks on result:
- not determinable
- Remarks:
- irritating effects
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 12%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Remarks on result:
- not determinable
- Remarks:
- irritating effects
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 12%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: irritating effects
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 12%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: irritating effects
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 6%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 6%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 6%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 6%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 9% - Bühler Test
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 9% - Bühler Test
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 9% - Bühler Test
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test item was found to have skin sensitising properties in the GPMT and in the Buehler test. The substance is classifiable according to CLP criteria.
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