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EC number: 280-445-7 | CAS number: 83411-71-6
- 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 December 20th 1994 to February 11th, 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP guideline study with some restrictions: no certificate of analysis
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no certificate of analysis
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA method is available
Test material
- Reference substance name:
- Bis(2,4,4-trimethylpentyl)phosphinic acid
- EC Number:
- 280-445-7
- EC Name:
- Bis(2,4,4-trimethylpentyl)phosphinic acid
- Cas Number:
- 83411-71-6
- Molecular formula:
- C16H35O2P
- IUPAC Name:
- bis(2,4,4-trimethylpentyl)phosphinic acid
- Test material form:
- liquid
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: D. Hall, Newchurch, Staffordshire, England
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 290-341g
- Housing: housed in groups of five in suspended metal cages with wire mesh floors
- Diet (e.g. ad libitum): A vitamin C enriched guinea-pig diet FD2, ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: yes, for 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From: To: no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- coconut oil
- Remarks:
- Alembicol D
- Concentration / amount:
- induction:
intradermal: 0.25%
topical: 100%
challenge: 25, 50 and 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- coconut oil
- Remarks:
- Alembicol D
- Concentration / amount:
- induction:
intradermal: 0.25%
topical: 100%
challenge: 25, 50 and 100%
- No. of animals per dose:
- 20 test animals, 10 control animals
- Details on study design:
- RANGE FINDING TESTS: 8 concentrations (between 0.1 and 10%) were tested on 2 animals by intradermal injection to study the skin irritation potential. Concentrations higher than 0.25 % caused severe skin reactions such as necrosis. 0.25 % was chosen as the intradermal induction concentration as it caused skin irritation without adverse effect in tested animals. Four concentrations (between 30 and 100%) were tested in 4 animals by topical application. The test item was not irritating at any concentrations.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal injection, 1 topical application
- Exposure period: topical application for 48h
- Test groups: FCA or TS in vehicle or TS in a 50:50 miwture of FCA and vehicle
- Control group: FCA, or vehicle or mixture of FCA and vehicle
- Site: 40 x 60 mm area of dorsal region on the scapular region (20 x 40 mm patch)
- Frequency of applications: -
- Duration: 0-7 days
- Concentrations:intradermal: 0.25 %, topical: 100 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 21 and day 28
- Exposure period: 24h
- Test groups: TS in vehicle
- Control group: TS in vehicle
- Site: left site of the flank (20 x 20 mm area)
- Concentrations: first challenge (d21): 50 and 100%; second challenge (d28): 25 and 50%
- Evaluation (hr after challenge): 24, 48, 72 hours after the removal of the patches
OTHER: during the induction period, on day 6, 0.2 ml of 10 % SLS in petrolatum was applied before the topical application of TS in order to induce a skin irritation reaction. - Challenge controls:
- 10 animals, same challenge treatment as the tested groups (50% and 100% TS)
- Positive control substance(s):
- no
- Remarks:
- HCA (the positive control is checked periodically at HRC)
Results and discussion
- Positive control results:
- the historical results of different tests performed with HCA between end of December 1992 and October 1994 were adequate.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Signs of dermal reaction such as dryness, thickening and sloughing of the epidermis. However, those effect are also observed in the control group at the same intensity.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% and 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Signs of dermal reaction such as dryness, thickening and sloughing of the epidermis. However, those effect are also observed in the control group at the same intensity..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Signs of dermal reaction such as dryness, thickening and sloughing of the epidermis. However, those effect are also observed in the control group at the same intensity.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 and 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Signs of dermal reaction such as dryness, thickening and sloughing of the epidermis. However, those effect are also observed in the control group at the same intensity..
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Signs of dermal reaction such as dryness, thickening and sloughing of the epidermis. However, those effect are also observed in the control group at the same intensity.
- Remarks on result:
- other: .
- Remarks:
- Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50 and 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Signs of dermal reaction such as dryness, thickening and sloughing of the epidermis. However, those effect are also observed in the control group at the same intensity.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no signs of skin irritation
- Remarks on result:
- other: Reading: rechallenge. Hours after challenge: 24.0. Group: test group. Dose level: 25 and 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no signs of skin irritation.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no signs of skin irritation
- Remarks on result:
- other: Reading: rechallenge. Hours after challenge: 48.0. Group: test group. Dose level: 25 and 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no signs of skin irritation.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no signs of skin irritation
- Remarks on result:
- other: Reading: rechallenge. Hours after challenge: 72.0. Group: test group. Dose level: 25 and 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no signs of skin irritation.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as a skin sensitiser according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- Non-skin sensitiser
- Executive summary:
In a guinea-pig maximisation test performed according to the OECD 406 Guideline and in compliance with the GLP, twenty male Dunkin/Hartley guinea-pigs were tested to assess the skin sensitisation potential of the test material.
In a preliminary study, different concentrations of the test substance were tested in order to determine the concentrations of the test substance that would produce irritation suitable for the induction phase of the main study and the maximum non-irritant concentration by the topical route of administration for the challenge phase of the main test.
In the main study, the animals received on day 1, an intradermal injection of the test substance diluted at 0.25 % in Alembicol D (coconut oil). Freund Complete Adjuvant (FCA) was also added to the mixture to potentiate the skin sensitisation. The control group was treated in the same condition with Alembicol D and FCA only. Six days after the intradermal induction, all animals (treated and control group) were treated with Sodium Lauryl Sulphate at 10 % in petrolatum. One day after (day 7), a topical application during 24h under occlusive patch conditions of undiluted (100 %, non irritant concentration) test substance was performed at the same site (dorsal region) in the treated group animals and a topical application of vehicle only was performed in the control group animals.
The first challenge test was conducted 2 weeks after the topical induction by applying the test substance on a different site (flank) at two different concentrations: 50 and 100 %. A second challenge test was conducted one week later (day 28) with lower concentrations (25 and 50 %). The challenge applications were performed under occlusive condition for 24h and the dermal reaction was assessed 24, 48 and 72 hours after the patch removal.
No signs of ill health or toxicity were recorded. During the induction exposure, dermal reactions were observed: necrosis after the intradermal injection of FCA and of test substance in FCA, and slight erythema after the topical application in the treated and control group. At the first challenge, dermal reactions were seen on both the control and test animals. Whilst the reactions seen for test animals were generally not more severe than those seen for the controls, the irritation seen for the control animals was considered to make precise evaluation of the test response difficult. A second challenge application was therefore carried out, one week later using lower concentrations of the test substance. At the second challenge application, there were no dermal reactions seen in any of the test or control animals.
Therefore, under the test conditions, the substance is not considered to be a skin sensitiser.
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