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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:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same 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
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
- 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)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: Induction phase 20% propylene glycol and 80% physiological saline (plus Freund's complete adjuvant during 2nd and 3rd weeks). For intracutaneos challenge - 20% propylene glycol and 80% physiological saline. For epicutaneous challenge - vaseline
- Concentration / amount:
- 0.1% for induction phase
0.1% for intradermal challenge
1% for epicutaneous challenge
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Induction phase 20% propylene glycol and 80% physiological saline (plus Freund's complete adjuvant during 2nd and 3rd weeks). For intracutaneos challenge - 20% propylene glycol and 80% physiological saline. For epicutaneous challenge - vaseline
- Concentration / amount:
- 0.1% for induction phase
0.1% for intradermal challenge
1% for epicutaneous challenge
- No. of animals per dose:
- 20 test animals for intracutaneous challenge
10 controls and 20 test animals for epicutaneous challenge - Details on study design:
- RANGE FINDING TESTS: no data
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 every 6 months using Paraphenylene-diamine or Potassium dichromate as positive controls.
- Positive control substance(s):
- yes
- Remarks:
- See challenge controls above
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 posiitive control assessments.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: Erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: Erythema.
Any other information on results incl. tables
Table 1: Cloquintocet-mexyl - Optimization test - Number of animals with signs of allergic skin reactions
Control group |
Test group |
|||
Scored after |
24 h |
48 h |
24 h |
48 h |
Intradermal challenge - Vehicle control - Cloquintocet-mexyl |
|
2/20 |
||
Epicutaneous challenge - Vehicle control - Cloquintocet-mexyl |
1/10 |
0/10 |
20/20 |
20/20 |
After epicutaneous challenge a number of females in the test group also had oedema, 3 after 24 hours and 2 after 48 hours.
Maximum erythema score 2 (maximum possible 4)
Maximum edema score 1 (maximum possible 4)
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Cloquintocet-mexyl was found to have skin sensitising potential in the guinea pig (optimization test), 20/20 responded positively to the epicutaneous challenge.
- Executive summary:
CGA185072 technical, purity 91.6%, batch P. 607001/002 was tested in a open epicutaneous maximisation test for sensitising potential. Guinea Pigs were allocated to control and test groups. In the induction phase: 0.1% CGA185072 in 20% propylene glycol + 80% physiological saline was injected in to 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% CGA185072 in 20% propylene glycol + 80% physiological saline. Epicutaneous challenge: 1% of the test article in vaseline. It was shown in a pretest that this was the highest non-irritating concentration. Dosing procedure: During the induction phase, every second day one intracutaneous injection was made into the back skin of the animals (total of 10 injections). After three injections without adjuvants, the seven following injections were made with complete Freund’s adjuvants. Fourteen days after the induction, intradermal challenge was made by a single injection into the skin of the left flank. Ten days after intracutaneous challenge, epicutaneous challenge was done by 24 hours dermal administration of the test article in vaseline under occlusive dressing (right flank). After epidermal challenge application of cloquintocet-mexyl, all treated animals showed positive skin reactions.
Cloquintocet-mexyl was assessed in the guinea pup using an optimisation test protocol - 20/20 responded positively to the epicutaneous challenge indicating that the test substance has sensitisation potential by skin contact.
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