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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 271-663-3 | CAS number: 68603-55-4
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no details on the test substance; no details on the control group; as first induction step, the test substance was applied on filter patches after an intracutaneous injection of an adjuvant saline mixture; only one reading after challenge at 24 hours
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid guinea pig study is available peformed before the LLNA protocol was established
Test material
- Reference substance name:
- Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates
- EC Number:
- 279-632-6
- EC Name:
- Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates
- Cas Number:
- 80939-62-4
- Molecular formula:
- na (UVCB)
- IUPAC Name:
- Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates
- Test material form:
- liquid: viscous
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain
- Sex:
- male/female
- Details on test animals and environmental conditions:
- The test was performed on 10 male and 10 female guinea pigs per
group weighing between 313 and 401 g ( 'vlo weeks old). The animals
were housed individually in Macrolon cages (type 3), assigned
to the different groups by means of random numbers generated
by the random number generator incorporated in the Hewlett-
Packard desk computer, identified with individual ear tags,
kept at a constant room temperature of 20 + 1 C, at a relative
humidity of 50 + 10% and on a 14 hours light cycle day. The
animals received ad libitum standard guinea pig pellets -
NAFAG No. 830, Gossau SG - and fresh water, supplemented with
fresh carrots.
The guinea pig is the animal of choice for sensitization studies
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: Adjuvant saline mixture = 50 % adjuvant complete Freund (Difco, Michigan), 50 % physiological saline
- Concentration / amount:
- 0.1 ml
- Day(s)/duration:
- First and second induction week
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- Induction: 10% in vaseline
Challenge: 30% in vaseline - Day(s)/duration:
- 1 d
- No. of animals per dose:
- 20 animals (10 males/10 females) in the test group, no details concerning the control group
- Details on study design:
- The test was performed on 10 male and 10 female guinea pigs per
group weighing between 313 and 401 g ( 'vlo weeks old). The animals
were housed individually in Macrolon cages (type 3), assigned
to the different groups by means of random numbers generated
by the random number generator incorporated in the Hewlett-
Packard desk computer, identified with individual ear tags,
kept at a constant room temperature of 20 + 1 C, at a relative
humidity of 50 + 10% and on a 14 hours light cycle day. The
animals received ad libitum standard guinea pig pellets -
NAFAG No. 830, Gossau SG - and fresh water, supplemented with
fresh carrots.
The guinea pig is the animal of choice for sensitization studies.
Control group:
A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound to control the maximal subirritant concentration of the test compound in adjuvant treated animals. - Challenge controls:
- After a rest period of 14 days the compound was
applied on filter paper patches ( 2 x 2 cm) to an untreated
flank skin of the animals for 24 hours epidermal occlusively.
Twenty four hours after removing the dressings the challenge reactions
were graded according to the Draize scoring scale (Appendix).
The application sites were chemically depilated before examination
(Veet , '^ 5 minutes) - Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- not specified
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- two male animals showed very slight erythema (grade 1); results of the control group were not given
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle and adjuvant
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: no information on a positive control is available.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Only two animals of the test group reacted after the challenge application of the test substance. The sensitizing potential of the test substance
can therefore be considered to be very low and the test substance is considered to be a non-sensitizer. - Executive summary:
The skin sensitizing potential fo the test susbtance was assessed in a Guinea pig mximization test (Ciba-Geigy, 1982). It was concluded that the test substance does not show a skin sensitizing effect in the Guinea Pig maximization test under the test conditions chosen.
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.