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EC number: 441-000-4 | CAS number: 121219-07-6 1-ETHOXY-2,3-DIFLUORBENZOL; 1-ETHOXY-2,3-DIFLUOROBENZENE; 2,3-DIFLUOROPHENETOL; DIPHOL
- 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
Skin sensitisation in vivo (OECD TG 406): no skin sensitisation potential (reference 7.4.1 -1).
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
- Study period:
- 2000-02-08 to 2000-03-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- July 1996
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was conducted due to non-REACH regulatory requirements. With the existing data from this study not only being acceptable but of good quality (Klimisch Score 1), this study precludes the need for an additional LLNA study. In addition, a supplementary LLNA study would violate the ECHA objectives with regards to animal welfare.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: about 6 weeks
- Weight at study initiation: 351 g (range from 313 to 399 g)
- Housing: in groups of two in a Makrolon cage type with a shelter placed on mobile racks
- Diet ad libitum, (Altromin Standard Diät TPF® 3012)
- Water: ad libitum, tap water
- Acclimation period: at least 7 days
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 40 - 64
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 25 g/L / 0.1 mL
- Day(s)/duration:
- 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: Freund's complete adjuvant with test substance + physiological saline
- Concentration / amount:
- 25 g/L / 0.1 mL
- Day(s)/duration:
- 1
- 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 / 1 mL
- Day(s)/duration:
- 7 / 48 hours
- Adequacy of induction:
- highest technically applicable concentration used
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 100 g/L / 0.5 mL
- Day(s)/duration:
- Day 21 / 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- RANGE FINDING TESTS:
To determine the concentrations suitable for the main study, a pretest with single intradermal or topical administrations of the vehicle and of test substance preparations was performed. Intradermal (i.d.) injections were given to one animal. Four further animals were used to determine the topical concentrations for the main study. Two of the guinea pigs were exposed for 48 hours without pretreatment to determine the concentration for the dermal induction. The other two animals were treated according to the control group including intradermal injections with FCA. One week after topical induction the two animals of the pretest group were exposed for 24 hours to different test material concentrations to find out the challenge concentration. In the pretest the following concentrations were used:
1. Sodium chloride solution: intradermal
2. Test substance with sodium chloride solution as vehicle:
intradermal: 50, 25, 10, 5, and 1 g/L
topical: undiluted and 500, 100, and 10 g/L
topical with FCA: 500, 100, 10, and 1 g/L
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6 intradermal and 2 topical exposures
- Exposure period: Day 1 (intradermal) and Day 14 (topical)
- Test groups:
intradermal:
1. Injection site: cranial
complete Freund's adjuvant (DIFCO LAB.) diluted 1:1 with physiological saline solution
2. Injection site: medial
25 g/L test substance formulated in physiological saline solution
3. Injection site: caudal
25 g/L test substance formulated at equal parts in physiological saline solution and complete Freund's adjuvant
topical:
Test item group: 0.5 mL 100 % test substance
- Control group: same treatment for intradermal and topical application without test substance.
- Site: shoulder region
- Frequency of applications: once
- Duration: 7 days (intradermal), 48 hours (topical)
- Concentrations: 25 g/L interadermal; 100 % topical
B. CHALLENGE EXPOSURE
- No. of exposures: 1 exposure
- Day(s) of challenge: 21
- Exposure period: 24 hours
- Test groups: undiluted test substance loaded on hypoallergenic patch
- Control group: like test group
- Site: shoulder region
- Concentrations: 10 % (100 g/L)
- Evaluation (hr after challenge): 24 and 48 hours - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
- Positive control results:
- 5 g/L alpha-hexylcinnamaldehyde in physiological saline led to the expected results. 50 % positive reactions were observed after challenge application.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 g/L (10 %)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 g/L (10 %)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 g/L (10 %)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 g/L (10 %)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5 g/L
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5 g/L
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin sensitising properties were observed in the guinea pig maximisation test.
- Executive summary:
In a dermal sensitisation study with the test substance in in physiological saline, 30 female Dunkin Hartley guinea pigs (20 animals for the test item group and 10 control animals) were tested using the guinea pig maximisation test (GMPT) in accordance with OECD guideline 406 and EU method B.6. Animals were between about 6 weeks old and exhibited a weight range of 313 - 399 g at the beginning of the study.
Induction included intradermal injection of test material preparation (25 g/L with and without Freund's complete adjuvant) on day 1, and topical application of undiluted test material on day 8.
Challenge by topical application of the test material preparation (100 g/L) was performed two weeks after topical induction.
The challenge using a 10 % test item formulation led to no skin effects in the animals of the treatment group or of the control group.
In summary, under the conditions of the maximization test and with respect to the evaluation criteria the test item therefore exhibits no skin-sensitization potential.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a dermal sensitisation study with the test substance in in physiological saline, 30 female Dunkin Hartley guinea pigs (20 animals for the test item group and 10 control animals) were tested using the guinea pig maximisation test (GMPT) in accordance with OECD guideline 406 and EU method B.6. Animals were between about 6 weeks old and exhibited a weight range of 313 - 399 g at the beginning of the study.
Induction included intradermal injection of test material preparation (25 g/L with and without Freund's complete adjuvant) on day 1, and topical application of undiluted test material on day 8.
Challenge by topical application of the test material preparation (100 g/L) was performed two weeks after topical induction.
The challenge using a 10 % test item formulation led to no skin effects in the animals of the treatment group or of the control group.
In summary, under the conditions of the maximization test and with respect to the evaluation criteria the test item therefore exhibits no skin-sensitization potential.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered not to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) No 2019/521.
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