Registration Dossier
Registration Dossier
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EC number: 406-250-0 | CAS number: 72619-32-0 HALOXYFOP R-(+)-ME HERBICIDAL CHEMICAL
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Not provided
Test material
- Reference substance name:
- Methyl (R)-2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate
- EC Number:
- 406-250-0
- EC Name:
- Methyl (R)-2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate
- Cas Number:
- 72619-32-0
- Molecular formula:
- C16H13ClF3NO4
- IUPAC Name:
- methyl 2-(4-{[3-chloro-5-(trifluoromethyl)pyridin-2-yl]oxy}phenoxy)propanoate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Haloxyfop-R Methyl Ester Technical
Lot # RMM 1783
Purity: Not reported
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Females nulliparous and non-pregnant: not specified]
- Age at study initiation: Approximately eight to twelve weeks
- Weight at study initiation: 362-449 g
- Housing: The animals were housed in groups of up to three in solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-21°C
- Humidity: 46-63%
- Air changes: 15 per hr
- Photoperiod: 12 hrs dark /12 hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 1%, 5%, 10% or 25% wlv in arachis oil B.P.
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Undiluted
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- other: highest concentration producing only mild to moderate dermal irritation after a 48-hour occlusive exposure
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 75% and 50% (v/v) in arachis oil B.P.
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Sighting study: 4
Main study: 15 (10 for test group and 5 for control group) - Details on study design:
- RANGE FINDING TESTS: The concentrations of test substance to be used at each stage of the main study were determined by 'sighting tests' in which groups of guinea pigs were treated with various concentrations of test substance. The procedures were as follows:
a} Selection of Concentration for Intradermal Induction
Four animals were intradermally injected with preparations of test substance (1%, 5%, 10% or 25% w/v in arachis oil). The highest concentration (up to a maximum of 25%) that caused only mild to moderate irritation and that did not cause systemic toxicity, was selected for the intradermal induction stage of the main study.
b) Selection of Concentration for Topical Induction
Two guinea pigs (intradermally injected with Freund's Complete. Adjuvant nine days earlier) were treated with the undiluted test substance and three preparations of the test substance (75%, 50% and 25% v/v in arachis oil).
The highest concentration producing only mild to moderate dermal irritation after a 48-hour occlusive exposure, was selected for the topical induction stage of the main study.
c) Selection of Concentration for Topical Challenge
The undiluted test substance and three preparations of the test substance (75%, 50% and 25% v/v in arachis oil) were applied occlusively to the flanks of two guinea pigs for a period of 24 hours. These guinea pigs did not form part of the main study but had been treated identically to the control animals of the main study, up to Day 14. The highest non-irritant concentration of the test substance and one lower concentration were selected for the topical challenge stage of the main study.
MAIN STUDY
A. INTRADERMAL INDUCTION EXPOSURE
- No. of exposures: 1
- Test groups: a 25% (w/v) dilution of test material in arachis oil and a 25% (w/v) dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus arachis oil
- Control group: Freund's Complete Adjuvant plus distilled water in the ratio 1:1
- Site: 3 sties (Each side of the mid-line)
- Frequency of applications: Single
B. TOPICAL INDUCTION EXPOSURE
- No. of exposures: 1 (one week after intradermal exposure)
- Exposure period: Day 7
- Site: Same sit of intradermal induction
- Frequency of applications: Single
- Duration: 48 h
- Concentrations: Undiluted test substance
C. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day of challenge: Day 21
- Exposure period: 24 h
- Site: Right shorn flank and left shorn flank for test and control respectively
- Concentrations: 75 and 50% (v/v)
- Evaluation (hr after challenge): 24 and 48 hrs - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75% & 50% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75% & 50% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: HCD data
- Hours after challenge:
- 0
- Group:
- positive control
- Dose level:
- 0.25%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Historical positive control data was provided
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance produced a 0% (0/10) sensitisation rate and is a non-sensitiser to guinea pig skin
- Executive summary:
A study was performed to assess the skin contact sensitisation potential of the test substance in the albino guinea pig. The method used followed the guidelines OECD 406 (Skin Sensitisation) and EU Method B.6 (Skin Sensitisation).
Ten test and five control animals were used for the main study.
Based on the results of sighting tests, the concentrations of test substance for the induction and challenge phases were selected as follows:
Intradermal Induction: 25% (w/v) in arachis oil B.P.
Topical Induction: Undiluted as supplied
Topical Challenge: 75% and 50% (v/v) in arachis oil B.P.
The test substance produced a 0% (0/10) sensitisation rate and is a non-sensitiser to guinea pig skin. The test substance is not classified regarding potential to cause sensitisation by skin contact and no symbol or risk phrase is required (93/21/EEC).
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