Registration Dossier
Registration Dossier
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EC number: 407-550-4 | CAS number: 69184-17-4
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)
- Rationale for reliability incl. deficiencies:
- other: GLP-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:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Adopted on 1984.
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Methyl O-(4-amino-3,5-dichloro-6-fluoropyridin-2-yloxy)acetate
- EC Number:
- 407-550-4
- EC Name:
- Methyl O-(4-amino-3,5-dichloro-6-fluoropyridin-2-yloxy)acetate
- Cas Number:
- 69184-17-4
- Molecular formula:
- Hill formula: C8 H7 Cl2 F N2 O3 CAS formula: C8 H7 Cl2 F N2 O3
- IUPAC Name:
- methyl 2-[(4-amino-3,5-dichloro-6-fluoropyridin-2-yl)oxy]acetate
- Details on test material:
- - Name of test material (as cited in study report): Fluroxypyr methyl ester
- Physical state: dark grey powder
- Analytical purity: 90.8%
- Purity test date: 28.08.1990
- Lot/batch No.: C-3B
- Expiration date of the lot/batch: August 1992
- Storage condition of test material: at room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Staffordshire, England
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 422-550 g
- Housing: suspended cages with wire mesh floors
- Diet (ad libitum): vitamin C-enriched guinea-pig Diet F.D.1 (Hay was given weekly)
- Water (ad libitum): drinking water
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 21
- Humidity (%): 30-70
- Air changes (per hr): approx. 19
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: acetone
- Concentration / amount:
- Induction (intradermal): 0.5%
Induction (epicutaneous): 75%
Challenge: 40 and 75%
75% is the maximum practical concentration and did not give rise to irritating effects.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- Induction (intradermal): 0.5%
Induction (epicutaneous): 75%
Challenge: 40 and 75%
75% is the maximum practical concentration and did not give rise to irritating effects.
- No. of animals per dose:
- 20 (test group)
10 (control group) - Details on study design:
- RANGE FINDING TESTS:
Concentrations:
Intradermal: 0.1, 0.25, 0.5, 1.0, 2.5, 5.0, 7.5 and 10.0%
Epicutaneous: 20, 50, 60 and 75%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: Day 1 (intradermal) and Days 7-9 (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture FCA/water
Injection 2: fluroxypyr methyl ester at 0.5% (w/w) in 5% acetone in Alembicol
Injection 3: fluroxypyr methyl ester at 0.5% (w/w) in a 1:1 mixture (v/v) FCA/5% acetone in Alembicol
Epicutaneous: On Day 6 the exposure site was pre-treated by gentle rubbing with 0.2 mL per site of 10% w/w sodium lauryl sulphate in petrolatum. On Day 7 a filter paper (2 x 4 cm) was saturated with approx. 0.4 mL of fluroxypyr methyl ester, 75% w/w in acetone and applied to the test area of clipped skin and held in contact by an occlusive dressing for 48 h.
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: 5% acetone in Alembicol
Injection 3: a 1:1 mixture (v/v) FCA/5% acetone in Alembicol
Epicutaneous: On Day 6 the exposure site was pre-treated by gentle rubbing with 0.2 mL per site of 10% w/w sodium lauryl sulphate in petrolatum. On Day 7 a filter paper (2 x 4 cm) was saturated with approx. 0.4 mL of 5% acetone in Alembicol and applied to the test area of clipped skin and held in contact by an occlusive dressing for 48 h
- Site: dorsal skin on the scapular region
- Frequency of applications: single
- Duration: Days 1-9
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: Days 21-23
- Test groups: test substance
- Control group: test substance
- Site: left flank
- Evaluation (hr after challenge): 24 and 48 h - Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the guinea-pig strain used is checked periodically at H.R.C. with formalin, a known sensitizer.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40%
- 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: 40%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40%
- 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: 40%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- 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: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- 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: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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