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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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-10-21 to 2014-11-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted under GLP conditions in accordance with the official OECD guideline No 405 (2012).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (2012)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- (May, 2008)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- (August, 1998)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF, 12 Nousan, Notification No 8147 (November, 2000; including the most recent partial revisions)
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: light yellow powder with lumps (determined at WIL Research Europe B.V.)
- Storage condition of test material: at room temperature in the dark
- Other: pH (1% in water, indicative range) 7.3-7.3 (determined by WIL Research Europe B.V.)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L’Arbresle Cedex, France
- Age at study initiation: between 12 and 24 weeks old
- Weight at study initiation: at least 1.5 kg
- Housing: individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
- Diet (e.g. ad libitum): Pelleted diet for rabbits approx. 100 grams per day; hay and wooden sticks ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before the start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C
- Humidity (%): 40 to 70%
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): average 54.2 mg (range 54.0 - 54.4 mg) - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- Irritation: 1 hr, 24, 48, 72 hours and 7 days after instillation
Mortality/Viability: twice daily.
Toxicity: at least once daily.
Body Weight: day of treatment (prior to instillation) and after the final observation. - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to OECD 405 and in addition:
Area of cornea involved:
No ulceration or opacity: 0
One quarter or less but not zero: 1
Greater than one quarter, but less than half: 2
Greater than half, but less than three quarters: 3
Greater than three quarters, up to whole area: 4
Discharge:
No discharge (may include small amounts observed in inner canthus of normal animals): 0
Any amount different from normal and/or lacrimation: 1
Discharge with moistening of the lids and hairs just adjacent to lids: 2
Discharge with moistening of the lids and hairs (considerable area around the eye): 3
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Irritation: Instillation of approximately 54 mg of Lithium salt of branched-aliphatic dicarboxylic acid (a volume of approximately 0.1 mL) into one eye of each of three rabbits resulted in effects on the iris and conjunctivae.
Iridial irritation was observed 1 hour after installation and resolved within 24 hours.
The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 7 days in all animals.
No corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.
Corrosion: There was no evidence of ocular corrosion. - Other effects:
- Coloration / Remnants: No staining of (peri) ocular tissues by the test substance was observed and no test substance remnants were seen.
Toxicity / Mortality: No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Table1: Individual eye irritation scores
|
|
Cornea |
|
Iris |
|
Conjunctivae |
|
Comments |
|||||||
Animal |
Time after dosing |
|
Opacity (0-4) |
Area (0-4) |
Fluor area (%)2 |
|
(0-2) |
|
Redness (0-3) |
Chemosis (0-4) |
Discharge (0-3) |
|
|||
|
|
|
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
7971 |
1 hour |
|
0 |
0 |
|
|
1 |
|
2 |
2 |
2 |
|
- |
||
|
24 hours |
|
0 |
0 |
0 |
|
0 |
|
2 |
1 |
1 |
|
- |
||
|
48 hours |
|
0 |
0 |
|
|
0 |
|
1 |
1 |
1 |
|
- |
||
|
72 hours |
|
0 |
0 |
|
|
0 |
|
1 |
0 |
0 |
|
- |
||
|
7 days |
|
0 |
0 |
|
|
0 |
|
0 |
0 |
0 |
|
- |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
802 |
1 hour |
|
0 |
0 |
|
|
1 |
|
2 |
2 |
2 |
|
- |
||
|
24 hours |
|
0 |
0 |
0 |
|
0 |
|
2 |
1 |
1 |
|
- |
||
|
48 hours |
|
0 |
0 |
|
|
0 |
|
1 |
0 |
1 |
|
- |
||
|
72 hours |
|
0 |
0 |
|
|
0 |
|
1 |
0 |
1 |
|
- |
||
|
7 days |
|
0 |
0 |
|
|
0 |
|
0 |
0 |
0 |
|
- |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
805 |
1 hour |
|
0 |
0 |
|
|
1 |
|
2 |
2 |
2 |
|
- |
||
|
24 hours |
|
0 |
0 |
0 |
|
0 |
|
2 |
1 |
1 |
|
- |
||
|
48 hours |
|
0 |
0 |
|
|
0 |
|
1 |
1 |
1 |
|
- |
||
|
72 hours |
|
0 |
0 |
|
|
0 |
|
1 |
1 |
1 |
|
- |
||
|
7 days |
|
0 |
0 |
|
|
0 |
|
0 |
0 |
0 |
|
- |
1Sentinel,2 Green staining after fluorescein treatment (percentage of total corneal area)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Iridial irritation was observed 1 hour after installation and resolved within 24 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 7 days in all animals. Based on these results, Lithium salt of branched-aliphatic dicarboxylic acid does not have to be classified for eye irritation.
- Executive summary:
Acute eye irritation/corrosion study with Lithium salt of branched-aliphatic dicarboxylic acid in the rabbit.
The study was carried out based on the guidelines described in:
OECD No.405 (2012) "Acute Eye Irritation / Corrosion"
EC, No 440/2008, B5: "Acute Toxicity: Eye Irritation/Corrosion"
EPA, OPPTS 870.2400 (1998): "Acute Eye Irritation"
JMAFF Guidelines (2000), including the most recent revisions.
Single samples of approximately 54 mg of Lithium salt of branched-aliphatic dicarboxylic acid (a volume of approximately 0.1 mL) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 days after instillation.
Instillation of the test substance resulted in effects on the iris and conjunctivae. Iridial irritation was observed 1 hour after installation and resolved within 24 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 7 days in all animals.
Based on these results, Lithium salt of branched-aliphatic dicarboxylic acid does not have to be classified and has no obligatory labelling requirement for eye irritation according to the:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011)(including all amendments),
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).
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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