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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1982-11-30 to 1982-03-12
- 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, 24h exposure period instead of 4h recommended in the guideline (worst case condition), occlusive patch (worst case condition), only two observation time (24h and 72h), no assessment of the reversibility of the effects.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : no certificate of analysis, 24h exposure period instead of 4h recommended in the guideline (worst case condition), occlusive patch (worst case condition), only two observation times (24h and 72h), no assessment of the reversibility of the effects.
- GLP compliance:
- yes
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hare Haven Rabbitry, Middleboro, MA, USA
- Age at study initiation: 10 to 13 weeks
- Weight at study initiation: 2.3 to 2.7 kg
- Housing: no data
- Diet: Charles River rabbit formula, lot #W2300
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature: 74 ± 5 °F
- Humidity: 50 ± 15 %
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded on left side, unabraded (shaved) on right side
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 and 72 hours after patch removal
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: trunk. Two independent sites were exposed to the test substance (Site 1 and 2) on each flank of the animals: 2 sites on abraded skin (left side) and 2 sites on unabraded skin (right side)
- % coverage: no data
- Type of wrap if used: the test substance was introduced under a "1 x 1" gauze pad previsously secured to the test site with surgical tape. the animals were wrapped with an impervious covering (plastic wrap) and then stockinette to prevent removal of the patches by the animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data
SCORING SYSTEM: the scores were calculated at 24 and 72h after the patch removal according to the Draize scale.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin-Site 1 and Site 2
- Basis:
- other: 2 out of 6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin-Site 1 and Site 2
- Basis:
- other: 2 out of 6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin-Site 1 and Site 2
- Basis:
- other: 1 out of 6
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin-Site 1 and Site 2
- Basis:
- other: 1 out of 6
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- edema score
- Remarks:
- abraded skin-Site 1
- Basis:
- other: 3 out of 6
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- edema score
- Remarks:
- abraded skin-Site 1 and Site 2
- Basis:
- other: 2 out of 6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- edema score
- Remarks:
- abraded skin-Site 1 and Site 2
- Basis:
- other: 1 out of 6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- abraded skin-Site 2
- Basis:
- other: 1 out of 6
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritant / corrosive response data:
- The test substance caused erythema and edema to the abraded and intact test sites of all of the rabbits at the 24h observation period. By the 72h observation period, all erythema and edema subsided completely in one rabbit. In three other rabbits all erythema subsided. Of the remaining two rabbits, one displayed erythema and edema on the abraded test sites and edema on the intact sites. The other animal displayed erythema and edema on the abraded and intact test sites at the 72 h observation period. No irritation was observed on the control sites. The primary irritation score was 2.2.
- Other effects:
- no other effects
Any other information on results incl. tables
Irritant/corrosive response data for each animal at each observation time after the topical application of the test substance on unabraded skin
Score at time point / Reversibility |
Erythema |
Edema |
||
Max. score: 4 |
Max. score: 4 |
|||
|
Site 1 |
Site 2 |
Site 1 |
Site 2 |
24 h |
1/1/1/2/2/1 |
1/1/1/2/2/1 |
2/1/2/1/2/2 |
2/1/2/1/2/2 |
72 h |
0/0/0/0/0/1 |
0/0/0/0/0/1 |
1/1/0/1/1/1 |
1/1/0/1/1/1 |
Average 24h and 72h |
0.5/0.5/0.5/1.0/1.0/1.0 |
1.5/1.0/1.0/1.0/1.5/1.5 |
||
Reversibility |
No data |
No data |
Irritant/corrosive response data for each animal at each observation time after the topical application of the test substance on abraded skin
Score at time point / Reversibility |
Erythema |
Edema |
||
Max. score: 4 |
Max. score: 4 |
|||
|
Site 1 |
Site 2 |
Site 1 |
Site 2 |
24 h |
1/2/1/2/3/2 |
1/2/1/2/3/2 |
2/1/2/1/2/2 |
2/1/2/1/2/3 |
72 h |
0/0/0/0/1/1 |
0/0/0/0/1/1 |
1/1/0/1/1/1 |
1/1/0/1/1/1 |
Average 24h and 72h |
0.5/1.0/0.5/1.0/2.0/1.5 |
1.5/1.0/1.0/1.0/1.5/1.8 |
||
Reversibility |
No data |
No data |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as a skin irritant according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- Non-skin irritant
- Executive summary:
In a dermal irritation study performed similarly to the OECD guideline No. 404, 6 male New Zealand White rabbits, were dermally exposed to 0.5 ml of undiluted to the test material.
Prior to the topical application, the skin of the rabbit was prepared with an electric clipper to remove the hair. After clipping, the left side of the animal was prepared by making epidermal abrasions, while the right site remained intact (clipped but unabraded). The test substance was then applied on the skin (abraded or not) on two different application sites (site 1 and 2). Then the test siteswere covered with an occlusive dressing for 24 hours. Those exposure conditions correspond to a worst case approach as the test guidance recommends an exposure under semi-occlusive patch and for4h.Skin irritation was assessed and scored according to the Draize scale at 24 and 72 hrs after the topical application of the test patch.
The mean individual scores calculated within 2 scoring times (24 and 72 hrs) for the unabraded skin were 0.5/0.5/0.5/1.0/1.0/1.0 for erythema and 1.5/1.0/1.0/1.0/1.5/1.5 for edema. The reversibility of the effects was not assessed as the observation of the skin and the scoring ended 72hrs after the application of the test item. However, on the intact skin the scores observed at 72hrs on the intact skin of all animals are low (equal to 1) or equal to 0 (no more skin effect). Moreover between 24 and 72hrs time scoring , the scores for erythema and edema were decreasing which is in favor with the reversibility of the irritant effects.
Under the test conditions, and considering the mean scores (24/48/72h) the test is not considered as skin irritant when applied topically to rabbits.
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