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EC number: - | CAS number: -
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- in vivo study was conducted prior to REACH implementation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-01-05 - 1995-01-16 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- OECD-Guideline for Testing of Chemicals 405 "Acute Eye Irritation / Corrosion", adopted February 24, 1987.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amines, C11-13 (branched) alkyl, salts with O,O-bis(2-ethylhexyl) hydrogen dithiophosphate
- Molecular formula:
- C27H60NPS2O2 C28H62NPS2O2 C29H64NPS2O2 (main component)
- IUPAC Name:
- Amines, C11-13 (branched) alkyl, salts with O,O-bis(2-ethylhexyl) hydrogen dithiophosphate
- Test material form:
- liquid
- Details on test material:
- Before Substance ID change known as CAS 71888-91-0 EC 276-159-7
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Zimmermann, Schweizer Hof, D-73453 Untergröningen/Aalen
- Housing: The rabbits housed individually in wire grating cages (area 2450 cm², height 42 cm) without bedding.
- Diet (e.g. ad libitum): Raiffeisen-Ringfutter, Kaninchen Trockenfutter 52/P, Raiffeisen Kraftfutterwerk Kehl, ad libitum.
- Water (e.g. ad libitum): Community tap water from Karlsruhe; free access for the animals by daily changing of the watering-bottles.
- Acclimation period: The animals were acclimated to the test conditions for 5 days prior to the administration.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22 ° C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES:
Acclimatization: January 05, 1995 - January 09, 1995
Administration: January 10, 1995
Observation: January 10, 1995 - January 16, 1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1 week
- Number of animals or in vitro replicates:
- 3 animals, Identification numbers: female: 002, male: 007 and 008
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 h after administration the eye was carefully rinsed with NaCl 0.9 % in order to remove the residual test substance.
SCORING SYSTEM: according to table 1 of OECD-Guideline 405
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- identical in all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- identical in all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- No. 002, female
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- No. 007, male
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: day 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- No. 008, male
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: day 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- No. 002, female
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: day 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- No. 007, male
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: day 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- No. 008, male
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: day 2
- Irritant / corrosive response data:
- EYE REACTION
The test substance was applied undiluted in a dose of 0.1 ml into the right eye to each of 3 albino rabbits.
After evaluation of the eye reaction according to table 1 of the OECD-Guideline 405, all three rabbits developed the diffuse, crimson colour of the conjunctivae. Individual vessels were not easily discernible. These effects were estimated at grade 2 (maximum possible 3). Hyperemic blood vessels were not observed any more on day 2 (rabbit No. 007 and 008) or on day 3 (rabbit No. 002).
Furthermore, all three animals showed swelling of lids. This effect was estimated at grade 3 (rabbit No. 002) or at grade 2 (rabbit No. 007 and 008) (maximum possible 4). Swelling of lids was not observed any more on the 48th hour.
No rabbit showed any exsudation after administration and during the observation period.
Irritations and lesions of cornea or iris could not be observed.
The effects on conjunctivae attributed to the test item are reversible which was revealed by the last four days of the observation period.
In the untreated left eye which was used as control pathological symptoms could not be noted. - Other effects:
- - Other observations:
MORTALITY/TOXICOLOGICAL SYMPTOMS
After the administration of 0.1 ml test substance into the right eye none of the treated rabbits died during the experiment and observation period. Toxicological symptoms could not be observed.
BEHAVIOUR
The general behaviour of the rabbits treated was quiet and watchful. The behaviour pattern was not different to that of other rabbits which were not in the test.
BODY WEIGHT
During the experiment the body weight of all three rabbits increased.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- This study was performed in compliance with OECD-Guideline 405 under GLP, is well-documented and with sufficient information for classification, the results can hence be considered as reliable.
After evaluation of the eye reaction according to table 1 of the OECD-Guideline 405, all three rabbits developed the diffuse, crimson colour of the conjunctivae. Individual vessels were not easily discernible. These effects were estimated at grade 2 (maximum possible 3). Hyperaemic blood vessels were not observed any more on day 2 (rabbit No. 007 and 008) or on day 3 (rabbit No. 002).
Furthermore, all three animals showed swelling of lids. This effect was estimated at grade 3 (rabbit No. 002) or at grade 2 (rabbit No. 007 and 008) (maximum possible 4). Swelling of lids was not observed anymore on the 48th hour.
Irritations and lesions of cornea or iris could not be observed.
According to Regulation 1272/2008, a substance must be classified as eye irritant Cat. 2, if, when applied to the eye of an animal, a substance produces:
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 1 and/or
— iritis ≥ 1, and/or
— conjunctival redness ≥ 2 and/or
— conjunctival oedema (chemosis) ≥ 2
— calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days
Those gradings were not observed in the test. Cornea opacity score and Iris score were zero in all animals and all observation time points. Conjunctivae redness scores, mean over 24, 48, and 72h, were 1.0, 0.33, and 0.33 in the individual animals, and chemosis scores were each 0.33.
So, the criteria set out in Regulation 1272/2008 are not met here, and the substance does not need to be classified as irritating to the eyes. - Executive summary:
This experiment was performed as an "Acute Eye Irritation/Corrosion"-study in compliance with the OECD-Guideline for Testing of Chemicals 405 under GLP. The test substance was applied undiluted in a single dose of 0.1 ml into the right eye to each of 3 albino rabbits.
After evaluation of the eye reaction according to table 1 of the OECD-Guideline 405, all three rabbits developed the diffuse, crimson colour of the conjunctivae. Individual vessels were not easily discernible. These effects were estimated at grade 2 (maximum possible 3). Hyperaemic blood vessels were not observed any more on day 2 (rabbit No. 007 and 008) or on day 3 (rabbit No. 002)
Furthermore, all three animals showed swelling of lids. This effect was estimated at grade 3 (rabbit No. 002) or at grade 2 (rabbit No. 007 and 008) (maximum possible 4). Swelling of lids was not observed any more on the 48th hour.
Irritations and lesions of cornea or iris could not be observed.
Cornea opacity score and Iris score were zero in all animals and all observation time points. Conjunctivae redness scores, mean over 24, 48, and 72h, were 1.0, 0.33, and 0.33 in the individual animals, and chemosis scores were each 0.33.
Under the conditions of this experiment the test substance did not cause mortality. Toxicological symptoms could not be noted.
All symptoms observed turned out to be reversible.
The left eye was not treated and was used for control. Symptoms of eye irritation did not occur on this eye.
During the experiment all three animals had a weight gain.
GHS criteria are not met, the substance does not need to be classified as irritating to the eyes.
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