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Diss Factsheets
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EC number: 915-589-8 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Skin Sensitisation (OECD 406, GPMT, guinea pig): not sensitising
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:
- Dec 26, 1996 - May 8, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study conducted before LLNA was established.
- Species:
- guinea pig
- Strain:
- other: albino Crl:(HA)BR
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc.; Portage, Michigan, USA)
- Age at study initiation: young adult (age not precisely specified)
- Weight at study initiation: 350g - 550g
- Housing: individually in suspended screen-bottom stainless steel cages (during acclimation and throughout the study)
- Diet: Certified Guinea Pig Diet #5026 (PMI Feeds, Inc.) ad libitum
- Water: ad libitum
- Acclimation period: 7 days after receipt
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): relative humidity 50% (+/-20%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted (since the test item was non-irritating based on the results of the range finding test).
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted (since the test item was non-irritating based on the results of the range finding test).
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- total 34 of any sex
- Irritation screen study: 4
- Main study: 20 (test group)
10 (Irritation control group)
Identification by individual numbered ear tag - Details on study design:
- RANGE FINDING TESTS: Irritation screening study
- Four animals were treated with test item: undiluted, 25%, 50%, 75% (w/v in mineral oil). Each animal received two different concentrations.
- The test item was was applied to saturation to filter papers (Whatman No. 3, 2 cm x 2 cm), which were applied to both sides of each animal
(right and left side of the shaved back) and covered with overlapping strips of Blenderm™ tape and overwrapped with Elastoplast® tape.
- After 24 hours the patches were removed, and the application sites were wiped with wet disposable paper towels.
- The application sites were opserved at 24 and 48 hours after removal for dermal reactions.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal injections (Day 1):
2 pairs of intradermal injections within a 2 cm x 4 cm-area (3 injections on each side of the midline of the shoulder region)
- Test group: anterior sites: 0.1 mL of Freund's Complete Adjuvant (FCA; 1:1 dilution with sterile water)
medial sites: 0.1 mL suspension of test material (5% w/v in mineral oil)
posterior sites: 0.1 mL suspension of test material in Freund's Complete Adjuvant (5% w/v in 1:1 FCA in sterile water)
- Control group: anterior sites: 0.1 mL of Freund's Complete Adjuvant (1:1 dilution with sterile water)
medial sites: 0.1 mL of mineral oil
posterior sites: 0.1 mL mineral oil in Freund's Complete Adjuvant
Topical application
- Pretreatment with 10% w/w sodium lauryl sulfate (SLS) (Day 7)
- The test item or control item was was applied to saturation to filter papers (Whatman No. 3, 2 cm x 2 cm), which were placed over the injection site
and covered with overlapping strips of Blenderm™ tape and overwrapped with Elastoplast® tape (Day 8).
- After48 hours the patches were removed and the application sites were wiped with wet disposable paper towels.
- Test groups: Test item, FCA
- Control group: vehicle control (mineral oil), FCA
- Site: shoulder
- Frequency of applications: 2 (intradermal injection and topical application)
- Duration: 48 h (topical application)
- Concentrations: undiluted test item
B. CHALLENGE EXPOSURE (Day 22; two weeks after topical application)
- No. of exposures: 1
- Day of challenge: test day 22
- Exposure period: 24 h
- Test groups: Test item, vehicle
- Control group: Test item, vehicle
- Site: flanks
- Concentrations: undiluted test item(right side) and vehicle (left side)
- Application sites were covered with overlapping strips of Blenderm™ tape and overwrapped with Elastoplast® tape.
- Evaluation (hr after challenge): 24 h and 48 h
Clinical observation: daily until experimental termination - Challenge controls:
- A positive control study using the same maximisation method was conducted within six month of the conduct of the main study.
Control group: 5 animals
Test group: 10 animals - Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene (0.1% w/v in acetone)
- Positive control results:
- 1st reading (24 hrs after challenge): All animals of the test group challenged with 4-dinitrochlorobenzene (0.1% w/v in acetone) exhibited dermal
reactions in the range between 2 and 3 at the treated areas;
2nd reading (48 hrs after challenge): All animals of the test group challenged with 4-dinitrochlorobenzene (0.1% w/v in acetone) exhibited
desquamation, one in combination with subcutaneous hemorrhaging.
Control application of the test group did not result in any reactions.
All animals in the vehicle control group kept healthy after challenging. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted test item
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs observed
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs observed
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted test item
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs observed
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs observed
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- induction: 0.1% (w/v) intradermal, 0.3 % (w/v) epictuaneous, challenge: 0.1% (w/v)
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- induction: 0.1% (w/v) intradermal, 0.3 % (w/v) epictuaneous, challenge: 0.1% (w/v)
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- Under the conditions of the conducted GPMT test, the test substance did not exhibit sensitising properties.
CLP: not classified
Reference
In the preliminary irritation screening study the test material caused no dermal reaction in any animal at any concentration. Therefore it was administered undiluted for topical induction and for the challenge phase in the main study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A valid GLP-conform Guinea Pig Maximisation Test (Corning Hazelton 1997), provided no evidence of a sensitisation potential of Alkylation and transalkylation products of biphenyl with propene.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available skin sensitisation study performed with Alkylation and transalkylation products of biphenyl with propen is conclusive but not sufficient for classification, and thus, does not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP).
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.
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