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EC number: 800-484-0 | CAS number: 154518-38-4
- 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 3/3/2006 to 25/10/2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 154518-38-4 (Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters)
- IUPAC Name:
- 154518-38-4 (Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters)
- Reference substance name:
- Phosphoric acid, mono- and di-C11-14 (linear and branched) alkyl esters
- EC Number:
- 800-484-0
- Cas Number:
- 154518-38-4
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).
- IUPAC Name:
- Phosphoric acid, mono- and di-C11-14 (linear and branched) alkyl esters
- Reference substance name:
- Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters
- IUPAC Name:
- Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters
- Details on test material:
- - Physical state: liquid
- Analytical purity: 100 %
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Granja Cunícula San Bernardo, S.L
- Age at study initiation: 10-13 weeks
- Weight at study initiation: 2.3-3.1 Kg
- Housing: individually in a stainless steel cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL of the test item
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60 minutes, 24, 48,72 hours, 7 and 14 days after the period of exposure.
- Number of animals:
- three
- Details on study design:
- Erythematous lesions and eschars (most severely affected areas) - No erythema: 0 - Very slight erythema (hardly noticeable): 1 - Well defined erythema: 2 - Moderate to intense erythema: 3 - Intense erythema (reddening) or formation of eschars that impede scoring: 4 Edematous lesions - No edema: 0 - Very slight edema (hardly noticeable): 1 - Slight edema (the edges of the zone are well defined by concrete elevations): 2 - Moderate edema (1 mm elevations, approximately): 3 - Intense edema (elevations of more than 1 mm and that extend beyond of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: only very slight erythema (grade 1) and slight desquamation remaining
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 3.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Initially after 24 and 48 hours after removal of the patch during 3 minutes well defined erythema (grade 2) was observed, along with very slight edema (grade 1). After 72 hours the erythema had decreased, and only very slight erythema (grade 1) and dryness were recorded. At 7 and 14 days after removing the cited patch, no skin lesions were recorded. After 24, 48 and 72 hours, intense erythema (grade 4) was observed in one of the animals, along with intense edema (grade 4) at 24 and 48 hours, and moderate edema (grade 3) at 72 hours. after 7 days the erythema had decreased to well defined erythema (grade 2) and desquamation was observed on the area administered. After 14 days very slight erythema (grade 1) and slight desquamation were observed in one of the animals.
Any other information on results incl. tables
Bodyweight (kg) |
|||||||
Observation period |
|||||||
Animal no. |
Day of treatment |
24h |
48h |
72h |
7d |
14d |
|
2378 |
2,73 |
2,73 |
2,77 |
2,73 |
2,94 |
3,12 |
|
2162 |
2,31 |
2,33 |
2,38 |
2,43 |
2,54 |
2,77 |
|
2166 |
3,14 |
3,22 |
3,23 |
3,28 |
3,45 |
3,77 |
|
Primary Dermal Irritation Test |
|||||||
Animal no. (Exposure) |
Response |
60 min |
24 h |
48 h |
72 h |
7 d |
14 d |
2378 (3 minutes) |
Erythema |
0 |
2 |
2 |
1' |
0 |
0 |
Edema |
0 |
1 |
1 |
0 |
0 |
0 |
|
2378 (1hour) |
Erythema |
1 |
2 |
2 |
2' |
0 |
0 |
Edema |
0 |
2 |
2 |
1 |
0 |
0 |
|
2378 (4hours) |
Erythema |
3 |
4 |
4 |
4 |
22,3 |
0 |
Edema |
4 |
4 |
4 |
4 |
0 |
0 |
|
1:Dryness |
|||||||
2':Desquamation |
|||||||
3':Areas of epidermal regeneration |
|||||||
Primary Dermal Irritation Test |
|||||||
Animal no. (Exposure) |
Response |
60 min |
24 h |
48 h |
72 h |
7 d |
14 d |
*2378 (4 hours) |
Erythema |
3 |
4 |
4 |
4 |
23,5 |
0 |
Edema |
4 |
4 |
4 |
4 |
0 |
0 |
|
2162 (4 hours) |
Erythema |
3 |
4 |
4 |
4 |
23 |
14 |
Edema |
4 |
4 |
4 |
3 |
0 |
0 |
|
2166 (4 hours) |
Erythema |
3 |
3 |
31 |
32,3 |
13 |
04 |
Edema |
4 |
3 |
2 |
2 |
0 |
0 |
|
1:Slight dryness |
|||||||
2':Dryness |
|||||||
3':Desquamation |
|||||||
4:Slight desquamation |
|||||||
5:Areas of epidermal regeneration |
|||||||
*: Corresponds to the animal administered, to which 3 patches were sequentially applied. |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- The alterations induced by the test item were evaluated following the OECD Guideline 404 and Method B.4. In view of the results obtained, the test item is considered to be irritant , based on the criteria set out in directive 2001/59/EC, Annex VI, and it is therefore assigned the risk phrase R38. According to CLP, EU GHS (Regulation (EC) No 1272/2008) the test item has to be classified as Category 2 (irritant).
- Executive summary:
In a primary dermal irritation study according to the OECD Guideline for the Testing of Chemicals 404 and Commission Directive 2004/73/EC Method B.4, 3 female, young adult New Zealand white rabbits were dermally exposed to 0.5 mL of Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters (100% a.i.) for 4 hours. Animals then were observed for 14 days.
At 60 minutes after removal of the patch exposed during 4 hours, moderate to intense erythema (grade 3) was observed, along with intense edema (grade 4). At 24, 48 and 72 h the erythema had evolved to intense erythema (grade 4), and the intense edema persisted at all the observations.
After 7 days well defined erythema (grade 2) was recorded, along with desquamation and areas of epidermal regeneration. Full recovery was observed after 14 d.
Similar findings were observed on 2 further animals: After 24, 48 and 72 h, intense erythema (grade 4) was observed in one animal along with intense edema (grade 4) at 24 and 48 h and moderate edema (grade 3) at 72 h. After 14 d very slight erythema (grade 1) and slight desquamation were still present in this animal.
Moderate to intense erythema (grade 3) was recorder in the third animal after 24, 48 and 72 h, accompanied with moderate edema (grade 3) at 24 h and slight edema (grade 2) at 48 and 72 h. After 14 d the erythema had remitted, only slight desquamation was observed.
The means of the erythema and edema evaluations at 24, 48 and 72 hours for the three animals after a four-hour exposure were 4/4/3 (erythema) and 4/3.6/2.3 (edema).
In this study, Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters is an skin irritant (Category 2) based on the criteria of Regulation (EC) No. 1272/2008.
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