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EC number: 430-710-1 | CAS number: 15290-77-4
- 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:
- From 1997-09-23 to 1997-10-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- OJ No. L383A, 29.12.92
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This in vivo skin sensitisation study was carried out before 10 May 2017, and that in compliance with EC B.6.
Test material
- Reference substance name:
- -
- EC Number:
- 430-710-1
- EC Name:
- -
- Cas Number:
- 15290-77-4
- Molecular formula:
- C5H3F7
- IUPAC Name:
- 1,1,2,2,3,3,4-heptafluorocyclopentane
Constituent 1
- Specific details on test material used for the study:
- Batch No.: 9705-2A
Purity: 98.18 %
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England.
- Microbiological status of animals, when known:
- Age at study initiation: 5-8 weeks
- Weight at study initiation: 317-405 g
- Housing: housed in groups of five in suspended metal cages with wire mesh floors
- Diet: vitamin C enriched guinea-pig diet (Harlan Teklad 9600 FD2 SQC), ad libitum; Hay given weekly
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0-24.0
- Humidity (%): 34-66
- Air changes (per hr): Ca. 15
- Photoperiod: 12 hrs dark / 12 hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 30% v/v / 0.1 mL
- 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:
- 100% / 0.4 mL
- Day(s)/duration:
- six days after the injections
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 100%, 50% v/v
- Day(s)/duration:
- two weeks after the topical induction
- No. of animals per dose:
- Test: 10
Vehicle controls: 5 - Details on study design:
- RANGE FINDING TESTS:
Animals were pre-treated with an intradermal injection of Freund's complete adjuvant, 50 : 50 with water for irrigation (Ph.Eur.), approximately two weeks prior to the start of the preliminary investigations.
Intradermal injections concentrations: 0.1 % - 100% v/v
Typical application concentrations: 30 %, 50 %, 70%, 100 % v/v。
Maximum concentration not causing irritation affects in the preliminary study: 100%.
MAIN STUDY
A. INDUCTION EXPOSURE
- Induction intradermal injections - test animals:
A 40 x 60 mm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers. Three pairs of intradermal injections were made into a 20 x 40 mm area within the clipped area.
Injectables for the test animals were prepared as follows:
1. Freund's complete adjuvant was diluted with an equal volume of water for irrigation (Ph.Eur.).
2. Test item, 30% v/v in Alembicol D.
3. Test item, 30% v/v in a 50 : 50 mixture of Freund's complete adjuvant and Alembicol D.
- Induction topical application - test animals:
Six days after the injections, the same 40 x 60 mm interscapular area was clipped and shaved free of hair and the site was pre-treated by gentle rubbing with 0.5 mL per site of 10% w/w sodium lauryl sulphate in petrolatum. Twenty-four hours later a 20 x 40 mm patch of Whatman No. 3 paper was saturated with approximately 0.4 mL of test item, as supplied. The patch was placed on the skin of the test animals and covered by a length of impermeable plastic adhesive tape (50 mm width "Blenderm"). This in turn was firmly secured by elastic adhesive bandage (50 mm width "Elastoplast") wound round the torso of the animal and fixed with "Sleek" impervious plastic adhesive tape. The dressing was left in place for 48 hours.
- Induction - control animals:
Treated similarly to the test animals with the exception of the test substance was omitted from the intradermal injections and topical application.
B. CHALLENGE EXPOSURE
- Challenge - control and test animals:
The control and test animals were challenged topically two weeks after the topical induction application using test item, as supplied and 50% v/v in Alembicol D.
Hair was removed by clipping and ten shaving from an area on the left flank of each guinea-pig. A 20 x 20 mm patch of Whatman No. 3 paper was saturated with approximately 0.2 mL of HFCPA, as supplied and applied to an anterior site on the flank. The test item, 50% w/w in Alembicol D was applied in a similar manner to a posterior site. The patches were scaled to the flank for 24 hours under strips of “Blenderm" covered by “Elastoplast" wound round the trunk and secured with “Sleck".
- Evaluation: evaluated 24 and 48 hours after removal of the patches.
OTHER:
- Clinical signs: observed daily for signs of ill health or toxicity
- Bodyweight: recorded on Day 1 (day of intradermal injections) and on the last day observations were made of dermal responses to the challenge applications. - Challenge controls:
- 30% and 100%
- Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- Hexyl cinnamic aldehyde (HCA): 10/10, 10/10 positive results obtained in two recent tests.
Benzocaine and mercaptobenzothiazole (MBT): 10/10, 9/10 positive results obtained in two recent tests.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity recorded
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity recorded
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity recorded
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity recorded
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of ill health or toxicity recorded
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of ill health or toxicity recorded
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of ill health or toxicity recorded
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of ill health or toxicity recorded
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Dose level:
- 50, 100% v/v
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- No data
- Remarks on result:
- other: test material: HCA
- Group:
- positive control
- Dose level:
- 83.33 and 40 % v/v
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- No data
- Remarks on result:
- other: MBT
- Group:
- positive control
- Dose level:
- 83.33 and 40 % w/v
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- No data
- Remarks on result:
- other: MBT
Any other information on results incl. tables
Signs of irritation during induction:
Intradermal: Necrosis was recorded at sites receiving Freund' s Complete Adjuvant in test and control animals.Slight irritation was seen in test animals at sites receiving test item 30% v/v in Alembicol D and slight irritation was observed in control animals receiving Alembicol D.
Topical: Slight erythema was observed in test and control animals.
Challenge: no dermal reactions observed
Bodyweight: No effects
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified.
- Conclusions:
- The test item did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the test aniamals.
- Executive summary:
This study was designed to assess the skin sensitisation potential of test item using the guinea-pig following EC B.6. Ten test and five control animals were used.
Based on the results of a preliminary study and in compliance with the guideline, the following dose levels were selected: Intradermal injection: 30% v/v in Alembicol D; Topical application: As supplied; Challenge application: As supplied and 50% v/v in Alembicol D.
The test item did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the test animals.
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