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EC number: 807-840-4 | CAS number: 64896-70-4
- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from November 19,2007 to November 26,2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline No.405; GLP conditions (as the data is used in a read-across approach, a maximal reliability score of 2 was attributed).
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- Name: LAB 3822.
Supplier: ROQUETTE FRERES.
Batch Number: FAL 07/25.
Galenic form: slightly yellowish liquid.
Molecular weight (salt form): not applicable.
Molecular weight (base form): about 426 g/mol.
Salt/Base ratio: not applicable.
Expiry date: March 2009.
On 17.Jul.2007, 26.2 kg samples of test item were received, in vial labelled ”LAB 3822, batch No.FAL 07/25”. The Sponsor confirmed that ”LAB 3822 - Di-ester-isosorbide” in the certificate of analysis corresponds to ”LAB 3822”, name used throughout the study plan.
Storage condition: Immediately upon receipt, LAB 3822 was registered, then stored at ambient temperature in accordance with the Sponsor's instructions.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Animals came from the CEGAV specialised breeding establishment (Les Hautes Noes, Saint Mars d'Egrenne, 61350 Passais la Conception, France).
- Age at study initiation: Generally between 9 and 12 weeks at the start of the experiment.
- Weight at study initiation: Between 2.004 kg and 2.538 kg at the start of the experiment.
- Housing:Observation was performed at the time of delivery of the animals and daily during the acclimatisation period. Animals were housed individually in cages of standard size.
- Diet (e.g. ad libitum): SDS/DIETEX STANRAB (P) SQC feed was available ad libitum. The criteria for acceptable levels of contaminants in the feed supplied were within the limits of the analytical specifications established by the diet manufacturer.
- Water (e.g. ad libitum):Drinking water was available ad libitum in polycarbonate bottles with a stainless steel nipple. A specimen of water is sent every 6 months to the Laboratoire Départemental d'Analyse du Cher - 216 rue Louis Mallet, 18014 Bourges Cedex, France, for analysis. The criteria for acceptable levels of contaminants in the water supplied were within the limits of the analytical specifications.
- Acclimation period:For at least 5 days before the treatment, in the area where the experiment took place.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-21°C
- Humidity (%): between 45% and 65%
- Air changes (per hr): 10 exponent -15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml of LAB 3822 was introduced into the conjunctival sac of the eye of each animal
- Duration of treatment / exposure:
- 8 Days
- Observation period (in vivo):
- 8 Days
- Number of animals or in vitro replicates:
- Three animals
- Details on study design:
- The day of instillation was taken as the first study day D1. LAB 3822 was instilled once.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1,2 and 3
- Time point:
- other: 1 hour
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1,2 and 3
- Time point:
- other: day 2,3,4,5 and 8
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 1,2 and 3
- Time point:
- other: 1 hour
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 1,2 and 3
- Time point:
- other: day 2,3,4,5 and 8
- Max. score:
- 0
- Irritation parameter:
- other: lacrimation
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Max. score:
- 2
- Irritation parameter:
- other: lacrimation
- Basis:
- animal: 2 and 3
- Time point:
- other: 1 hour
- Max. score:
- 1
- Irritation parameter:
- other: lacrimation
- Basis:
- animal: 1,2 and 3
- Time point:
- other: day 2,3,4,5 and 8
- Max. score:
- 0
- Irritation parameter:
- other: redness
- Basis:
- animal: 1,2 and 3
- Time point:
- other: 1 hour
- Max. score:
- 2
- Irritation parameter:
- other: redness
- Basis:
- animal: 1 and 2
- Time point:
- other: day 2 and 3
- Max. score:
- 1
- Irritation parameter:
- other: redness
- Basis:
- animal #3
- Time point:
- other: day 2 and 3
- Max. score:
- 2
- Irritation parameter:
- other: redness
- Basis:
- animal: 1,2 and 3
- Time point:
- other: day 4
- Max. score:
- 1
- Irritation parameter:
- other: redness
- Basis:
- animal: 1 and 2
- Time point:
- other: day 5
- Max. score:
- 1
- Irritation parameter:
- other: redness
- Basis:
- animal #3
- Time point:
- other: day 5
- Max. score:
- 0
- Irritation parameter:
- other: redness
- Basis:
- animal: 1,2 and 3
- Time point:
- other: day 8
- Max. score:
- 0
- Irritation parameter:
- other: cornea opacity
- Basis:
- animal: 1,2 and 3
- Time point:
- other: 1 hour
- Max. score:
- 0
- Irritation parameter:
- other: cornea opacity
- Basis:
- animal: 1,2 and 3
- Time point:
- other: day 2,3,4,5 and 8
- Max. score:
- 0
- Irritation parameter:
- other: aera of cornea involved
- Basis:
- animal: 1,2 and 3
- Time point:
- other: 1 hour
- Max. score:
- 0
- Irritation parameter:
- other: aera of cornea
- Basis:
- animal: 1,2 and 3
- Time point:
- other: day 2,3,4,5 and 8
- Max. score:
- 0
- Irritant / corrosive response data:
- non irritant
Any other information on results incl. tables
All data were recorded as and when obtained using forms identified by the study number. Data were presented tabulated by animal number and time, nature, severity and duration of effects.
Calculation of ocular primary irritation indices
Mean indices were calculated from results obtained for each rabbit by direct examination at times 24 hours, 48 hours and 72 hours. The surface area of corneal opacity and the lacrimation are not taken into account in the calculation of mean index. For each parameter, mean of indices for each rabbit for the three times is noted (Mean index per parameter, per animal for the three times = Mi). The maximum theoretical score is 4 (chemosis), 3 (redness), 2 (iris lesions) and 4 (corneal lesions).
Criteria of classification :
Symbols |
Indications of danger | Risk phrases | Cornea | Iris | Redness | Chemosis |
Xi | Irritant | R41:risk of serious damage to eyes | Mi>=3 in at least 2 animals | Mi=2 in at least 2 animals | / | / |
or if ocular lesions persist at the end of the reversibility period or if the test item causes irreversible discolouration of the eyes | ||||||
R36:irritating to eyes | 2<=Mi<3 in at least 2 animals | 1<=Mi<2 in at least 2 animals | Mi>=2.5 in at least 2 animals | Mi>=2 in at least 2 animals | ||
None | None | None | None of the above situations |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions adopted, LAB 3822 (FAL 07/25) was found to be non irritant for the eye of the rabbit.
- Executive summary:
SUMMARY
Irritant property of the test item LAB 3822 (FAL 07/25) was evaluated following a single ocular instillation in the rabbit in accordance with general requirements of OECD Guideline No. 405 (April 24, 2002), method B5 of Commission Directive No. 2004/73/EC (April 29, 2004) adapting to technical progress for the 29th time Council Directive No. 67/548/EEC and subsequent amendments enable full evaluation of the reversible or irreversible nature of any effects seen.
Three animals were used for the study.
0.1 mL of LAB 3822 was introduced into the conjunctival sac of the left eye of each of the three rabbits used. The untreated right eye served as a control.
Any conjunctival, iris and corneal lesion was evaluated approximately one hour, then on days D2, D3, D4, D5 and D8 after instillation of LAB 3822.
Results obtained were as follows:
Conjunctivae: 1 hour after instillation, a slight lacrimation was observed in three animals.
1 hour after instillation and until D4, a redness (score 1 or 2) was observed in three animals.
On D5, a redness (score 1) was seen in two animals.
No lesions of iris and cornea were seen in animals.
Table 1 Mean index (Mi) LAB 3822
Treatment
Animal
number
Chemosis
Redness
Iris
Cornea
LAB 3822
20071207 0 1.00 0 0 LAB 3822 20071213 0 1.00 0 0 LAB 3822 20071209 0 1.67 0 0 Study Number 20070266STP
Under the experimental conditions adopted, LAB 3822 (FAL 07/25) was found to be non irritant for the eye of the rabbit. Classification according to Directive No. 67/548/EC and subsequent amendments: Symbol: none is required. Indication of danger: non is appropriate. Risk phrase: non is applicable.
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.
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