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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 November 1999 to 6 December 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 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 no 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: New Zealand White rabbits were supplied by Charles River UK Ltd, Margate, Kent, England.
- Age at study initiation: at least 14 weeks old
- Weight at study initiation: At the start of the study the animals weighed 2.8 to 3.1 kg
- Housing: The animals were individually housed in stainless steel cages with perforated floors.
- Diet (e.g. ad libitum): Free access to a standard laboratory rabbit diet (Special Diet Services, Stanrab (P) SQC pellet) was allowed throughout the study. Hay three times / week.
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.
- Acclimation period: Twenty days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 21°C
- Humidity (%): 28 to 52%
Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continuous light (0700 - 1900 hours) and twelve hours darkness.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 ml of the test substance was administered as supplied
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour, 24 hours, 48 hours, 72 hours and on Days 5 to 14.
- Number of animals:
- 3 males
- Details on study design:
- PROCEDURE:
Approximately 24 hours before the test item application, each rabbit was clipped free of hair from the dorso-lumbar region using electric clippers exposing an area of skin approximately 100 mm x 100 mm.
Approximately 0.5 ml of the test item was applied under a 2-ply 25 mm x 25 mm porous gauze pad to one intact skin site on each animal. Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.
At the end of the exposure period the semi occlusive dressing and gauze were removed from each animal and the treatment site washed with warm water to remove any residual test item. The treated area was blotted dry with absorbent paper.
Examination of the treated skin was made approximately 1 hour following removal of the dressings and 24, 48 and 72 hours after exposure. Additional observations were made for all animals on Days 5 through to 14. Local dermal irritation was assessed using the numerical system, see any other information on materials and methods
Any other skin reactions if present, were also recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 3687
- Time point:
- other: Mean of scores at 24, 48 and 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Necrotic patch
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 3687
- Time point:
- other: Mean of scores at 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 3688
- Time point:
- other: Mean of scores at 24, 48 and 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Necrotic patch
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 3688
- Time point:
- other: Mean of scores at 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 3869
- Time point:
- other: Mean of scores at 24, 48 and 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Necrotic patch
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 3869
- Time point:
- other: Mean of scores at 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Please see attached background information for individual skin reactions.
Severe erythema with slight to moderate oedema and necrotic patches were seen in all three animals. The necrotic patches began sloughing off in two animals on Day 11 revealing new skin underneath. Blanching of the skin and desquamation (characterised by dryness of the skin) were observed in all animals. Reactions gradually ameliorated however very slight to well defined erythema with or without very slight oedema was still evident in all animals at study termination on Day 14. - Other effects:
- There were no other signs of toxicity or ill health.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- A single semi occlusive application of the test substance to intact rabbit skin for four hours elicited severe dermal irritation with necrotic patches.
The test item meets the criteria for classification according to the Classification, Labelling and Packaging Regulation (CLP) or the Globally Harmonised Classification System. - Executive summary:
Introduction.
The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit. The method was designed to be compatible with the following:
- OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 17 July 1992)
- Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 92/69/EEC
- EPA Health Effects Test Guidelines OPPTS 870.2500 Acute Dermal Irritation EPA 712 -C-98 -196 (August 1998)
Results.
A single 4-hour, semi-occluded application of the test item to the intact skin of three rabbits for four hours elicited severe dermal irritation with necrotic patches.
Conclusion.
The test item is classified as corrosive according to the Classification, Labelling and Packaging Regulation (CLP) or the Globally Harmonised Classification System.
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