Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 269-119-5 | CAS number: 68187-67-7
- 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:
- 6 December 1999 to 17 January 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea pig maximisation test according to OECD 406 was performed in 2000 prior to the adoption of the OECD 429 local lymph node assay in 2002.
Test material
- Reference substance name:
- Amines, C12-14-alkyl, isooctyl phosphates
- EC Number:
- 269-119-5
- EC Name:
- Amines, C12-14-alkyl, isooctyl phosphates
- Cas Number:
- 68187-67-7
- Molecular formula:
- C19H42NPO4 - C29H63NPO4
- IUPAC Name:
- Amines, C12-14-tert-alkyl, isooctyl mono phosphates
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Nulliparous and non preganant female Dunkin/Hartley strain guiea pigs were supplied by D Hall, Newchurch, Staffs, UK. The animals were approximately 4 to 7 weeks of age on arrival and were acclimatised for six days prior to the start of the main study. At the start of the study the animals were in the weight range of 395 to 435g.
An additional 10 animals from the same supplier were used for the preliminary investigations.
The animals on the main study were allocated without conscious bias to either control or test groups. Each animal was identified by ear tattoo number.
The guinea pigs were housed in groups of five in suspended metal cages with wire mesh floors.
Free access to drinking water and food ( a vitamin C enriched guinea pig diet, Teklad 9600 FD2 SQC) was allowed throughout the study. Hay was given three times a week.
The temperature and relative humidity were controlled to remain within target ranges of 16 to 22°C and 32 to 60%, respectively. Lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Alembicol D (a product of coconut oil)
- Concentration / amount:
- 0.1% test item in Alembicol D
- Day(s)/duration:
- Intradermal injection on Day 1
- Adequacy of induction:
- other: Highest concentration that caused irritation but did not adversely affect the animals
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Alembicol D (a product of coconut oil)
- Concentration / amount:
- 10% test item in Alembicol D
- Day(s)/duration:
- application for 48 hours one week after intradermal induction
- Adequacy of induction:
- other: Highest concentration that produced some irritation but did not adversely affect the animals
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Alembicol D (a product of coconut oil)
- Concentration / amount:
- 1% test item in Alembicol D
- Day(s)/duration:
- application for 24 hours two weeks after epicutaneous induction
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Alembicol D (a product of coconut oil)
- Concentration / amount:
- 0.5% in Alembicol D
- Day(s)/duration:
- application for 24 hours two weeks after epicutaneous induction
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Alembicol D (a product of coconut oil)
- Concentration / amount:
- 1% test item in Alembicol D
- Day(s)/duration:
- application for 24 hours one week after the first epicutaneous challenge
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Alembicol D (a product of coconut oil)
- Concentration / amount:
- 0.5 % test item in Alembicol D
- Day(s)/duration:
- application for 24 hours one week after the first epicutaneous challenge
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Control animals : 5
Test animals : 10 - Details on study design:
- PRELIMINARY STUDIES:
The intradermal and topical irritancy of dilutions of the test substance was investigated to identify where possible
- concentrations of the test substance that would produce irritation suitable for the induction phase of the main study, and,
- a maximum non-irritant concentration by the topical route for the challenge phase
The animals for the topical irritancy investigations were pre-treated with an intradermal injection of Freuds complete adjuvant, 50:50 with water, approximately one week prior to the start of the preliminary investigations.
Intradermal injections - Intradermal injections (0.1ml/site) were made to the clipped flank of 2 guinea pigs, using a range of concentrations (0.1 to 10% v/v) of test material in a suitable vehicle ( Alembicol D). The resulting dermal responses were assessed approximately 24 and 72 hours later.
Topical application - Patches of Whatmen NO. 3 paper (20 x 20mm) were saturated (volume approximately 0.2ml / patch) with a range of concentrations (0.005% v/v to as supplied) of test material in vehicle (Alembicol D) and applied to the clipped and shaved flanks of 8 guinea pigs. The patches were covered by a strip of 'Blenderm' and secured by 'Elastoplast' wound round the trunk and fixed with 'Sleek' impervious plastic adhesive tape. The dressings were removed after an exposure of approximately 24 hours and the reaction sites assessed for erythema and oedema. Further examination of the sites was carried out approximately 24 and 48 hours after removal of the dressings.
MAIN STUDY:
Control group: 5 female guinea pigs
Test Group : 10 female guinea pigs
INDUCTION PHASE
TEST GROUP:
Intradermal Induction:
Test Group :
- 2 ID: Freund's Complete Adjuvant diluted with an equal volume of water for irrigation
- 2 ID: test item at 0.1% v/v in Alembicol D
- 2 ID: test item at 0.1% v/v in a 50 : 50 mixture of Freund's Complete Adjuvant and in Alembicol D.
Topical Induction:
One week after the injections the same 40 x 60 mm interscapular area was clipped and shaved free of hair. A 20 x 40 mm patch of Whatman No 3 paper was saturated with approximately 0.4ml of test material, 10% v/v in AlembIcol D. The patch was placed on the skin of the test animals and covered by a length of impermeable plastic adhesive tape. This in turn was secured by elastic adhesive bandage wound round the torso and fixed with 'Sleekimperviuos plastic adhesive tape.
CONTROL ANIMALS
During the induction phase, the control animals were treated similarly to the test animals with the exception that the test substance was omitted from the intradermal injections and topical application.
CHALLENGE PHASE: CONTROL AND TEST ANIMALS
The control and test animals were challenged topically two weeks after the topical induction application using the test material at 1% and 0.5% v/v in Alembicol D.
Hair was removed by clipping and then shaving from an area on the left flank of each guinea pig. A 20 x 20 mm patch of Whatman No 3 paper was saturated with approximately 0.2ml of test material., 1% v/v in Alembicaol D and applied to an anterior site on the flank. Test material 0.5% v/v in Alembicol D was applied in a similar manner to the posterior site. The patches were sealed to the flank for 24 hours under strips on 'Blenderm' secured with 'Elastoplast' wound round the trunk and fixed with 'Sleek'
A second challenge was made one week later. The method employed was the similar with the exception that the test substance 1 and 0.5% v/v was applied to the left flank of all the control and test animals.
OBSERVATIONS
Mortality and clinical signs were recorded daily. The bodyweight of each animal was recorded on the day of intradermal injections and on the last day that observations were made of the dermal response to the challenge application.
DERMAL RESPONSES
The dermal reactions resulting from intradermal induction and topical application on the preliminary study, and topical application at the challenge were assessed. - Challenge controls:
- During the induction phase, the control animals were treated similarly to the test animals with the exception that the test substance was omitted from the intradermal injections and topical application.
The control animals were challenged topically two weeks after the topical induction application using the test material at 1% and 0.5% v/v in Alembicol D - Positive control substance(s):
- yes
- Remarks:
- Hexyl cinnamic aldehyde conducted between 7 June and 10 July 1999.
Results and discussion
- Positive control results:
- All 10 test animals gave a positive sensitisation response.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Well defined or slight erythema with slight oedema observed in 2/10 animals. Dryness and sloughing of epidermis observed in another 1/10 animal.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Slight erythema and slight oedema observed in 2/10 animals
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Slight erythema and slight oedema observed in 2/10 animals. Dryness and sloughing of epidermis observed in another 1/10 animal.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Slight erythema and slight oedema observed in 2/10 animals
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Slight erythema and slight oedema and thickening, dryness and sloughing of the epidermis observed in 2/10 animals.
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Dryness and sloughing of epidermis in some animals
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Dryness and sloughing of epidermis in some animals
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Dryness and sloughing of epidermis in some animals
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Dryness and sloughing of the epidermis in one animal. Thickening dryness and sloughing of the epidermis in one animal.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- Slight erythema observed in 1/5 animals
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- Well defined erythema, slight oedema and thickness, dryness and sloughing of epidermis observed in 1/5 animals
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- slight erythema observed in 1/5 animals
Any other information on results incl. tables
Preliminary Screening Test
Please see the attached background material for the results of the preliminary investigations.
Main Test
There were no deaths or signs of systemic toxicity noted in the test or control group animals during the test.
Intradermal injections - Necrosis was observed at intradermal sites receiving Freuds Complete Adjuvant in test and control animals. Slight irritation was seen in test animals receiving the test substance 0.1% in Alembicol D and slight irritation was observed in control animals receiving Alembicol D.
Topical application - Moderate erythema with blanching of the dose site was observed in test animals following topical application of the test substancce 10% v/vin Alembicol D. Slight irritation was seen in the control guinea pigs.
Challenge - First challenge dermal reactions were more marked and persistent in 2 test animals compared to the control animals, therefore these 2 animals gave a positive response. The remaining 8 test animals gave negative responses. A second challenge was conducted to confirm reproducibility.
.
Second challenge - Dermal reactions of similar persistence and severity were observed for control and test animals.
For both challenges, dermal reactions were observed in the control group and as the responses seen in the first challenge were not reproducible in the same test anmals in the second challenge, the dermal reactions were considered to represent irritation rather than sensitisation.
Please see attached background information for results.
Results for the negative control rechallenge readings at 48 and 72 hours is given in the attached background information.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered to be a non-sensitiser under the conditions of the test.
- Executive summary:
Introduction.
A study was performed to assess the skin sensitisation potential of the test item in the guinea pig. The study was performed in compliance with the OECD Guideline for the Testing of Chemicals No. 406 "Skin Sensitisation (adopted 17 July 1992), Method B6 of Commission Directive 96/54/EC an d EPA Health Effects Test Guidelines OPPTS 870.2600 "Skin Sensitisation" EPA 712 -C-98 -197, August 1998.
Methods
Following a preliminary screening test guinea pigs were dosed by intradermal injection (0.1% v/v in Alembicol D) and topical application (10% V/V in Alembicol D). This was followed approximately 2 weeks later by a topical challenge application of 1 and 0.5% v/v in Alembicol D. A second challenge application was made one week later.
Results
Following the first challenge dermal reactions were more marked and persistent in two test animals compared to the control animals, suggesting a positive response in these two animals. The remaining eight animals gave a negative response.
Following the second challenge dermal reactions for test animals were of similar persistence and severity to those of the control animals.
For both challenges dermal reactions were observed in the control group and as the responses seen in the first challenge were not reproducible in the same test animals in the second challenge, the dermal reactions were considered to represent irritation rather than sensitisation.
Conclusion
The test item did not produce evidence of skin sensitisation in any of the ten test animals.
The test item does not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation (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.