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EC number: 700-571-2 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK Department of Health, 21 November 2005
Test material
- Reference substance name:
- Renewable hydrocarbons (diesel type fraction)
- EC Number:
- 700-571-2
- Cas Number:
- 928771-01-1
- Molecular formula:
- C10-20H22-42
- IUPAC Name:
- Renewable hydrocarbons (diesel type fraction)
- Details on test material:
- Name of test material (as cited in study report): NExBTL Biodiesel
- Description: Clear colourless liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd
- Age at study initiation: 12-20 wk
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually housed
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12 (lights on 0600-1800 hr)
IN-LIFE DATES: From: 18 June 2007 To: 28 June 2007
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Eye not washed or test substance otherwise removed after instillation
- Observation period (in vivo):
- 1, 24, 48 and 72 hr post-treatment
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Initially a single animal was used. Test substance (0.1 ml) was instilled into the conjunctival sac of the right eye and the upper and lower eyelids held together for approx. 1 sec before releasing. The left eye was untreated and served as a control. Occular responses were evaluated at 1, 24, 48 and 72 hr post-treatment using Draize criteria. Two additional rabbits were treated subsequently after assessment of treatment-related effects in the first.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no score observed following instillation
- Remarks on result:
- other: Score zero at all time points
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no score observed following instillation
- Remarks on result:
- other: score zero at all time points
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no score observed following instillation
- Remarks on result:
- other: score zero at all time points
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: zero score at all time points
- Remarks on result:
- other: Score zero at all time points
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: score zero at all time points
- Remarks on result:
- other: score zero at all time points
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: score zero at all time points
- Remarks on result:
- other: score zero at all time points
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other: conjunctival redness present a 1 hr, fully reversible within 24 hr
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hr
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48hr
- Remarks on result:
- other: conjunctival redness present at 1 and 24 hr, fully reversible in 48 hr
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hr
- Remarks on result:
- other: conjunctival redness present at 1 and 24 hr, fully reversible in 48 hr
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other: conjunctival redness present at 1 hr, fully reversible within 24 hr
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other: Chemosis present initially, fully reversed in 24 hr
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: chemosis present initially at 1 hour, fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Chemosis present initially, fully reversed in 24 hr
- Irritation parameter:
- other: discharge
- Basis:
- animal #1
- Time point:
- other: 1 hr
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other: Discharge present initially in all animals, fully reversed in 24 hr
- Irritation parameter:
- other: discharge
- Basis:
- animal #2
- Time point:
- other: 1 hr
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other: discharge present initially at 1 hr, fully reversible within 24 hours
- Irritation parameter:
- other: discharge
- Basis:
- animal #3
- Time point:
- other: 1 hr
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other: discharge present initially at 1 hr, fully reversible within 24 hr
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not irritating to eye
- Executive summary:
Eye irritation potential was evaluated in a GLP-compliant guideline study (method B5 of directive 2004/73/EC) using 3 New Zealand White rabbits. The test sample (0.1 ml) was instilled initially into the conjunctival sac of the right eye of one rabbit and the upper and lower eyelids held together for approx. 1 sec. to prevent loss of the sample, then released. The other eye served as a control. Ocular irritation was assessed 1, 24, 48 and 72 hr post-treatment using Draize criteria. After consideration of the responses evoked in the first animal, two additional rabbits were treated in an identical manner. Mild conjunctival redness, chemosis and discharge (all grade 1) were present in all treated eyes at the 1 hr time point but were generally fully resolved by 24 hr. The exception was the occurrence of residual mild conjunctival redness (grade 1) in a single animal at 24 hr (fully resolved by 48 hr). No corneal or iris effects were present in any animal at any time point. Under the conditions of the study NExBTL renewable diesel caused mild, fully reversible eye irritation.
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