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EC number: 428-100-3 | CAS number: 94239-04-0
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Not provided in the report
- Specific details on test material used for the study:
- Substance ID: F6TF
Lot #: 8922/16
Purity: 99.7% - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adults
- Weight at study initiation: 380-486 g
- Housing: five per cage in cages suitable for animals of this strain and the weight range expected during the course of the study
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 changes/hour
- Photoperiod (hrs dark / hrs light): Artificial, giving 12 hours light, 12 hours dark - Route:
- intradermal and epicutaneous
- Vehicle:
- other: corn oil or Freund's Complete Adjuvant
- Concentration / amount:
- Induction Phase (each animal received three injections plus a week later, the topical application)
Injection 1: Freund's Complete Adjuvant plus corn oil in the ratio 1:1
Injection 2: 10% w/v preparation of the test substance in corn oil
Injection 3: 10% w/v preparation of the test substance in Freund's Complete Adjuvant plus corn oil in the ratio 1:1
Topical Application: 0.2-0.3 mL undiluted test substance
Challenge Phase (each animal received the 2 topical applications)
Topical Application: 0.05-0.1 mL undiluted test substance
Topical Application: 0.05-0.1 mL 75% test substance in corn oil - Route:
- epicutaneous, occlusive
- Vehicle:
- other: corn oil or Freund's Complete Adjuvant
- Concentration / amount:
- Induction Phase (each animal received three injections plus a week later, the topical application)
Injection 1: Freund's Complete Adjuvant plus corn oil in the ratio 1:1
Injection 2: 10% w/v preparation of the test substance in corn oil
Injection 3: 10% w/v preparation of the test substance in Freund's Complete Adjuvant plus corn oil in the ratio 1:1
Topical Application: 0.2-0.3 mL undiluted test substance
Challenge Phase (each animal received the 2 topical applications)
Topical Application: 0.05-0.1 mL undiluted test substance
Topical Application: 0.05-0.1 mL 75% test substance in corn oil - No. of animals per dose:
- Test substance - 20
Control - 10 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
An area approximately 5 x 5 cm on the scapular region of each animal was clipped free of hair with a pair of veterinary clippers and a row of three injections (0.05-0.1 mL each) was made on each side of the mid-line. The injections were:
i) Top: Freund's Complete Adjuvant plus corn oil in the ratio 1: 1;
ii) Middle: a 10% w/v preparation of the test substance in corn oil;
iii) Bottom: a 10% w/v preparation of the test substance in a 1: 1 preparation of Freund's Complete Adjuvant plus corn oil.
Control animals were treated the same as the test animals, except that they were treated with corn oil in place of the test substance. The injections were checked for any adverse effects approximately 1 day after dosing. One week after intradermal injection, the scapular area was clipped again and treated with a topical application of the undiluted test substance. This preparation (0.2-0.3 mL) was applied on filter paper (approximate size 4 cm x 2 cm) which was held in place by a piece of surgical tape. The tape was covered by a strip of adhesive bandage (approximate size 20-30 cm x 5 cm) and secured by a piece of self-adhesive PVC tape. This occlusive dressing was kept in place for at least 48 hours. Control animals were similarly treated except that the test substance was not applied to the filter paper. The application sites were checked approximately 1 day after removal of the dressings, and twice further prior to challenge.
B. CHALLENGE EXPOSURE
Two weeks after the topical inductions, an area, approximately l5 cm x 5 cm, on both flanks of all the test and control animals, was clipped free of hair with a pair of veterinary clippers. An occlusive dressing was prepared which consisted of two pieces of filter paper (approximate size l cm x 2 cm) stitched to a piece of rubber sheeting (approximate size l2 cm x 5 cm). The undiluted test substance (0.05-0.l mL) was applied to one of the pieces of filter paper and a 75% w/v preparation in com oil (0.05-0.l mL) was applied to the second piece of filter paper. The dressing was placed on the shorn flank of the guinea pig so that the undiluted test substance was on the left and the 75% w/v preparation was on the right. It was then covered with a strip of adhesive bandage (approximate size 25-40 cm x 7.5 cm) which was secured by a self-adhesive PVC tape. After at least 24 hours, the dressings were carefully cut, using blunt-tipped scissors, removed and discarded. The position of the pieces of filter paper on the skin were identified using a black waterproof marker-pen. Skin sites were examined approximately I and 2 days after removal of the dressings. - Positive control substance(s):
- yes
- Remarks:
- A positive control study using hexylcinnamaldehyde was carried out at approximately 6 month intervals to ensure that the test system continued to respond to known sensitizers.
- Positive control results:
- The net percentage response was calculated to be 65% and, under the conditions of the test, hexylcinnamaldehyde was classified as a strong skin sensitizer.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 75% w/v
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 75% w/v
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Undiluted and 75% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Undiluted and 75% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not sensitising in the guinea pig Maximisation Test.
- Executive summary:
The sensitisation potential of the test substance was assessed using a method based on the maximisation test according to the guidelines OECD 406 and EU method B.6.
The skin sensitization potential of the test substance was assessed in a group of 20 guinea pigs. For the induction phase, the test substance was dosed intradermally as a 10% w/v preparation in corn oil (with or without Freund's Complete Adjuvant) and a week later, as an undiluted topical application. Two weeks after the topical induction the challenge phase was conducted with a topical application of a 75% test substance preparation in corn oil and undiluted test substance. Skin treatment sites were examined 24 hours later.
Slight erythema was seen in the test animals following intradermal induction. Following challenge of the induced guinea pigs with the test substance, there was no erythematous response in any of the test or control animals. The test substance was not a sensitizer under the conditions of the test.
Reference
Slight erythema was observed in test animals following intradermal induction.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization potential was assessed in guinea pigs. In the induction phase, the test substance was dosed intradermally as a 10% w/v preparation in corn oil (with or without Freund's Complete Adjuvant) and a week later, as an undiluted topical application. Two weeks after the topical induction, the challenge phase was conducted with a topical application of a 75% test substance preparation in corn oil and undiluted test substance. Following challenge of the induced guinea pigs with the test substance, there was no sensitization response in any of the test animals.
Migrated from Short description of key information:
OECD 406; no sensitization was observed in guinea pigs. Reliability = 1
Justification for classification or non-classification:
There was no evidence of dermal sensitization in guinea pigs. The substance does not need to be classified for sensitization according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Justification for classification or non-classification:
There was no evidence of dermal sensitization in guinea pigs. The substance does not need to be classified for sensitization according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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