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EC number: 619-447-3 | CAS number: 99607-70-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 May 1987 to 02 July 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was performed to meet the regulatory data requirements under a different legislation long before REACH came into force.
Test material
- Reference substance name:
- heptan-2-yl [(5-chloroquinolin-8-yl)oxy]acetate
- EC Number:
- 619-447-3
- Cas Number:
- 99607-70-2
- Molecular formula:
- C18H22ClNO3
- IUPAC Name:
- heptan-2-yl [(5-chloroquinolin-8-yl)oxy]acetate
- Details on test material:
- - Name of test material (as cited in study report): CGA185072 technical
- Analytical purity: 91.6%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source of test animals: Animal Production, Ciba-Geigy Ltd., Stein, Switzerland
- Age at study initiation: circa 10 weeks
- Weight at study initiation: 300 to 398 g
- Housing: conventional laboratory caging, not otherwise specified
IN-LIFE DATES: From: 11.05.1987 To: 02.07.1987
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: Test substance was dissolved in 20% propylene glycol and 80% physiological saline. During second and third week of induction, a mixture of the normal vehicle with complete Bacto adjuvant in a ratio 1:1 was used.
- Concentration / amount:
- 0.1% test substance applied in 0.1 mL solution
- Day(s)/duration:
- Every second day (except weekends), in total 10 intracutaneous injections
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 1%
- Day(s)/duration:
- 10 days after the intradermal challenge injection
- Adequacy of challenge:
- other: Sub-irritant dose
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- other: 20% propylene glycol plus 80% physiological saline
- Concentration / amount:
- 0.1% of test material dissolved in vehicle
- Day(s)/duration:
- 14 days after after the last injection during induction period.
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20 test animals for intracutaneous challenge
10 controls and 20 test animals for epicutaneous challenge - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: three weeks
- Test groups: 20 animals for intracutaneous challenge and 20 animals for epicutaneous challenge
- Control group: 10 animals
- Site: Dorsum of guinea pig
- Frequency of applications: 10 intracutaneous injections - the first three without adjuvant and seven including adjuvant
- Duration: Injections made every second day
- Concentrations: 0.1%
B. CHALLENGE EXPOSURE
- No. of exposures: Two. An intracutaneous challenge was made 14 days after last induction injection, into the left flank. Ten days later an epicutaneous challenge was applied (topical exposure for 24 hours) under an occlusive dressing
- Day(s) of challenge:
- Exposure period:
- Test groups:
- Control group:
- Site:
- Concentrations: 0.1% and 1% for intracutaneous and epicutaneous challenges respectively
- Evaluation (hr after challenge): Reactions evalauted 24 hours after intracutaneous challenge and 24 and 48 hours after epicutaneous challenge
OTHER: - Challenge controls:
- Concomitant control animals were treated with the vehicle only. The sensitivity of the test system was tested in an independent test every 6 months using Paraphenylene-diamine or Potassium dichromate as positive controls.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- The sensitivity of the test system was tested at six monthly intervals with paraphenylene-diamine or potassium dichromate. Historical positive control study results are not presented but the methods are assumed to be validated by the six-monthly positive control assessments.
In vivo (non-LLNA)
Resultsopen allclose all
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No relevant clinical signs observed.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No relevant clinical signs observed.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- No relevant clinical signs observed.
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Epicutaneous challenge
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- No relevant clinical signs observed.
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Epicutaneous challenge
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Not applicable
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- No relevant clinical signs observed.
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Intradermal injection challenge
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- No relevant clinical observations reported.
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Intradermal injection challenge
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Conclusions:
- Cloquintocet-mexyl was found to have skin sensitising potential in the guinea pig (optimization test).
- Executive summary:
The skin sensitising properties of the substances were tested under GLP to OECD TG 406 in an open epicutaneous maximisation test for sensitising potential. Guinea Pigs were allocated to control and test groups. In the induction phase, 0.1% test substance in 20% propylene glycol + 80% physiological saline was injected into the skin of the dorsum on three occasions in week 1. During the second and third week of the induction period, the test article was admixed to the vehicle and complete Freund’s adjuvant (1:1 v/v). A further 7 injections were administered every other day to give a total induction injection schedule of ten injections. Intracutaneous challenge was done with an injection of 0.1% test substance in 20% propylene glycol + 80% physiological saline 14 days after the last induction injection. There was no significant statistical difference of responses between the vehicle control group and the test group. A second, epicutaneous challenge was done 10 days after the intradermal injection challenge. 1% of the test article in vaseline was applied to the skin of the animals in the test group and was kept under occlusion for 24 hours. It was shown in a pretest that this was the highest non-irritating concentration. All animals treated treated in this way showed positive skin reactions in the skin readings after 24 and 48 hours. Cloquintocet-mexyl was found to be a skin sensitiser in this skin sensitisation maximisation test.
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