Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 424-210-0 | CAS number: 23911-85-5
- 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:
- 1996-09-09 to 1996-10-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- According to the Reach Annex VIII, 8.3.2 column 2 the in vivo studies carried out before 10 May 2017 and that meet the requirements set out in Article 13(3), first subparagraph, and Article 13(4) shall be considered appropriate to address this standard information requirement. The non-LLNA study was conducted in 1996, according to GLP, and based on the performance and results it is considered suitable to cover the sensitisation endpoint.
Test material
- Reference substance name:
- -
- EC Number:
- 424-210-0
- EC Name:
- -
- Cas Number:
- 23911-85-5
- Molecular formula:
- C29 H24 O7
- IUPAC Name:
- 2-benzoyl-5-[3-(4-benzoyl-3-hydroxyphenoxy)-2-hydroxypropoxy]phenol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Buftonon-Trent, Staffordshire, UK.
- Age at study initiation: 8 – 12 weeks old
- Weight at study initiation: males: 356 to 445 g
- Housing: in solid-floor polypropylene cages furnished with woodflakes
- Historical data: yes
- Diet (ad libitum): Guinea Pig FD1 Diet, special Diets services Limited, witham, Essex, uK)
- Water (ad libitum): yes, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 – 22
- Humidity (%): 47 – 68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- 5% (w/v)
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 25% (w/w)
- Day(s)/duration:
- Day 7
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- 10% (w/w)
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- 5% (w/w)
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- other: one lower than the highest non-irritant concentration of the test material
- No. of animals per dose:
- Number of animals for selection of concentrations: 8
Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- RANGE FINDING TESTS:
1. Intradermal Induction: Four concentrations of test material were investigated (25%, 10%, 5% and 1% w/v in arachis oil BP). Injections were attempted in a total of four guinea pigs. A 25% preparation was considered to be impractical to dose satisfactorily. Therefore three guinea pigs received four 0.1 mL injections of only one concentration of test material. The degree of erythema at the injection sites was assessed approximately 24, 48 and 72 hours and 7 days after injection according to the Draize scale (see reference). The degree of oedema was not evaluated. Any evidence of systemic toxicity was also recorded. The highest concentration that caused only mild to moderate skin irritation, and which was well tolerated systemically, was selected for the intradermal induction stage of the main study.
2. Topical Induction: Two guinea pigs (intradermally injected with Freund's Complete Adjuvant ten days earlier) were treated with four preparations of the test material (25%, 10%, 5% and 2% w/v in arachis oil BP). Applications were made to the clipped flanks under occlusive dressings for an exposure period of 48 hours. The degree of erythema and oedema was evaluated approximately 1, 24 and 48 hours after dressing removal. The highest concentration producing only mild to moderate dermal irritation was selected for the topical induction stage of the main study.
3. Topical Challenge: Four preparations of the test material (25%, 10%, 5% and 2% w/v in arachis oil BP) were applied to the clipped flanks of two guinea pigs under occlusive dressings for an exposure period of 2+ hours. These guinea pigs did not form part of the main study but had been treated identically to the control animals of the main study, up to Day 14. The degree of erythema and oedema was evaluated approximately 1, 24 and 48 hours after dressing removal. The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge stage of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: topical 1; intradermal: 1
- Exposure period: not applicable for intradermal, topical: 48 h
- Test groups: 2 , for challenge concentrations 10% and 5% in arachis oil BP, both treated with 3 injections at induction phase:
a) Freund's complete Adjuvant plus distilled water in the ratio 1:1
b) a 5% w/v suspension of the test material in arachis oil BP
c) a 5% w/v suspension of the test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water
- Control group: 1 (vehicle group) treated with
a) Freund's complete Adjuvant plus distilled water in the ratio 1:1
b) arachis oil BP
c) a 5% w/v suspension of the test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water
- Site: shoulder region
- Frequency of applications: Day 0: intradermal injections in a row, Day 7: topical application
- Duration: 9 days in total
- Concentrations: Intradermal: 5% w/v in Arachis oil BP, Topical Induction: 25% w/w in Arachis oil BP
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: Day 21
- Exposure period: 24 h
- Test groups: 2
- Control group: 1 (vehicle group)
- Site: right flank
- Concentrations: a) 10% (w/w) in Arachis oil BP; b) 5% (w/w) in Arachis oil
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 5% w/w in arachis oil BP was similarly applied to a skin site on the left shorn flank
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- The strain used in this study record has been shown to produce satisfactory sensitisation responses using known positive sensitisers. As positive control trials have been conducted in the testing laboratory on a regular basis, no positive control has been evaluated in the presented test.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- -
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Remarks:
- see "Positive control results"
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- -
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Remarks:
- see "Positive control results"
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 5 %
Signs of irritation during induction:
Intradermal Induction: Erythema was noted at the intradermal induction sites of test group animals at the 24 and 48-hour observations. Very slight erythema was noted at the intradermal induction sites of all control group animals at the 24-hour observation and three control group animals at the 48-hour observation.
Topical Induction:
Very slight to well-defined erythema (8/10 animals) and incidents of very slight oedema (2/10 animals) were noted at the topical induction sites of test group animals at the 1-hour observation.
Evidence of sensitisation of each challenge concentration: None
Bodyweights: Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FADEX He 1819 PK produced a 0% (0/10) sensitisation rate and was therefore classified as a non-sensitiser to guinea pig skin.
- Executive summary:
A study was performed to assess the contact sensitisation potential of the test material FADEX He 1819 pK in the albino guinea pig. The study was performed in compliance with the OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992) and Method B6 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
Ten test and five control animals were used for the main study. The bodyweight of each animal was recorded at the start and end of the study. Two main phases were involved in the main study; (a) an induction of a response and (b) a challenge of that response. Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as follows:
lntradermal lnduction: 5% w/v in arachis oil BP
Topical lnduction: 25% w/w in arachis oil BP
Topical Challenge: 10% and 5% w/w in arachis oil BP
Approximately 24 and 48 hours after challenge dressing removal, the degree of erythema and oedema was quantified using the scale according to Draize (1977).
The test material produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.