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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to Guideline study, tested with the source substance Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 97468-13-8 (Phosphoric acid, C9-11-branched and linear alkyl esters, potassium salts ) and 91844-80-3 (Phosphoric acid, C13-15-branched and linear alkyl esters, potassium salts); 50/50; 25% solution (solvent purification)
- IUPAC Name:
- 97468-13-8 (Phosphoric acid, C9-11-branched and linear alkyl esters, potassium salts ) and 91844-80-3 (Phosphoric acid, C13-15-branched and linear alkyl esters, potassium salts); 50/50; 25% solution (solvent purification)
- Reference substance name:
- Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts (25%) solution (solvent purification)
- IUPAC Name:
- Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts (25%) solution (solvent purification)
- Test material form:
- other: liquid
- Details on test material:
- - Test material: potassium salt of alkyl (C=9-15) phosphate (25%) solution (solvent purification)
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC, Inc.
- Weight at study initiation: ca.350g
- Housing: 4-5 amimals / metalic cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23+/-2
- Humidity (%): 50+/-10
- Air changes (per hr): 17 times/hr
- Photoperiod (hrs dark / hrs light): 12 hr/12 hr
IN-LIFE DATES: From: 1992-02-04 to 1992-03-08
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction:
interdermal with act.0.1 % test solution
dermal with act 5 % test solution
Challenge concentration:
act. 1.0 % and 0.5 % test solution
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction:
interdermal with act.0.1 % test solution
dermal with act 5 % test solution
Challenge concentration:
act. 1.0 % and 0.5 % test solution
- No. of animals per dose:
- 4 females for intradermal treatment in preliminary study.
4 females for epicutaneous (occlusive) treatment in preliminary study.
10 females for treatment group in main study.
5 females for control group in main study. - Details on study design:
- PRELIMINARY STUDY
A. Topical application
Irritation assessment following 24h occlusive exposure to test material at act. 10, 5, 1, 0.5, 0.1 and 0.05% in water; skin assessment 3, 24 and 48 hr after treatment.
Result: act. 5% will be used for induction phase and act. 1.0 and 0.5 % will be used for challenge in main study.
B. Intradermal
0.1 ml of test substance at act. 1.0, 0.5, 0.1, 0.05 % solution applied intradermally in physiological saline. Assessments was made 24, 48 and 72h post‐administration.
Result: act. 0.1 % will be used in main study.
MAIN STUDY
A. INDUCTION EXPOSURE
Day 0: Treatment group:
− Injection 1: 1:1 mixture (v/v) FCA/physiological saline
− Injection 2: 0.1 % test substance in physiological saline
− Injection 3: 0.1 % test substance in a 1:1 mixture (v/v) FCA/physiological saline
Control group:
- Injection 1: 1:1 mixture (v/v) FCA/physiological saline
- Injection 2: physiological saline
- Injection 3: 1:1 mixture (v/v) FCA/physiological saline
Day 7: Treatment group:
Region, free of fur, was treated topically with a 2 x 4 cm patch of Lint cloth, fully loaded with an 0.2 mL of test substance solution (act. 5%). Patch was covered by an occlusice bandage and left in place for 48 hours.
Control group:
Only vehicle (distilled water) was applied.
B. CHALLENGE EXPOSURE
Day 21: Flank of all animals, including controls, treated topically with 0.1 ml of act. 1.0 and 0.5 % solution in distilled water of test substance for 24h under an occlusive patch.
GRADING SYSTEM
Dermal reactions graded by the following criteria:
-; 0; no reaction
+-; 1; a slight erythema
+; 2; clear erythema
++; 3; clear erythema with edema
+++; 4; eschar, necrosis - Challenge controls:
- In challenge phase, 91 -S-008 [Diadol 115L-MAP K (25%) solution (liquid–liquid extraction)] and 91 -S-007 -B
[Diadol 115L-MAP K (25%) solution (no purification)] were also used in the same concentrations. - Positive control substance(s):
- no
Results and discussion
Any other information on results incl. tables
Table Skin sensitization study of diadol115L-MAP K (25%) solution (solvent purification) in guinea pigs (GPMT method)
Test substance |
Concentration (%) |
Vehicle |
Test group |
Control |
|||||
Average reaction intensity |
Average reaction intensity |
||||||||
Max |
Positive (+) |
Time |
Max |
Positive (+) |
Time |
||||
1 |
91-S-007-A |
1.0 |
water |
0 |
0 |
- |
0 |
0 |
- |
2 |
91-S-007-A |
0.5 |
water |
0 |
0 |
- |
0 |
0 |
- |
3 |
91-S-008 |
1.0 |
water |
0 |
0 |
- |
0 |
0 |
- |
4 |
91-S-008 |
0.5 |
water |
0 |
0 |
- |
0 |
0 |
- |
5 |
91-S-007-B |
1.0 |
water |
0 |
0 |
- |
0 |
0 |
- |
6 |
91-S-007-B |
0.5 |
water |
0 |
0 |
- |
0 |
0 |
- |
Table Intradermal injection of 91-S-007-A [diadol 115L-MAP K (25%) solution (solvent purification)]
Observation |
24 hr |
48 hr |
72 hr |
||||||||||
concentration |
1 % |
0.5 % |
0.1 % |
0.05 % |
1 % |
0.5 % |
0.1 % |
0.05 % |
1 % |
0.5 % |
0.1 % |
0.05 % |
|
No. of animals |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
|
judge |
- |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
4 |
+- |
0 |
0 |
1 |
2 |
0 |
0 |
2 |
1 |
0 |
0 |
3 |
0 |
|
+ |
0 |
0 |
3 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
|
++ |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
+++ |
4 |
4 |
0 |
0 |
4 |
4 |
0 |
0 |
4 |
4 |
0 |
0 |
vehicle: physiological saline
Table 24 hours occlusive patch of 91-S-007-A [diadol 115L-MAP K (25%) solution (solvent purification)]
Observation |
3 hr after patch removal |
24 hr after patch removal |
48 hr after patch removal |
||||||||||||||||
concentration |
a |
b |
c |
d |
e |
f |
a |
b |
c |
d |
e |
f |
a |
b |
c |
d |
e |
f |
|
No. of animals |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
|
judge |
- |
0 |
0 |
4 |
4 |
4 |
4 |
0 |
0 |
4 |
4 |
4 |
4 |
0 |
0 |
4 |
4 |
4 |
4 |
+- |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
|
+ |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
|
++ |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
+++ |
4 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
vehicle: physiological saline
concentration a: 10%, b: 5%, c: 1%, d: 0.5%, e: 0.1%, f: 0.05%
Table 24 hours occlusive patch of 91-S-008 [diadol115L-MAP K (25%) solution (liquid-liquid extraction)]
Observation |
3 hr after patch removal |
24 hr after patch removal |
48 hr after patch removal |
||||||||||||||||
concentration |
a |
b |
c |
d |
e |
f |
a |
b |
c |
d |
e |
f |
a |
b |
c |
d |
e |
f |
|
No. of animals |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
|
judge |
- |
0 |
0 |
4 |
4 |
4 |
4 |
0 |
0 |
4 |
4 |
4 |
4 |
0 |
0 |
4 |
4 |
4 |
4 |
+- |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
|
+ |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
|
++ |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
+++ |
3 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
vehicle: physiological saline
concentration a: 10%, b: 5%, c: 1%, d: 0.5%, e: 0.1%, f: 0.05%
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- The test substance can be classified as a non-sensitiser to the guinea pig under the conditions of this study.
- Executive summary:
Skin sensitization potential of Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts (25%) solution (solvent purification) was studied in female guinea pigs by the Maxmization test. The animals were induced by intradermal injection and topical application of the test article in the clipped shoulder region.
No erythema nor edema was observed in the test article or vehicle control group by challenging with 1.0 and 0.5 % solution of the test article.
From the results, Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts was concluded to have no skin sensitization potential in the conditions used in this study.
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