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Diss Factsheets
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EC number: 932-833-9 | 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
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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 8-11 Nov 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study was conducted according to the appropriate OECD test guideline and in compliance with GLP. The original study was considered reliability 1. Read-across to the registered substance is considered scientifically justified and is reliability 2.
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Trisodium citrate
- EC Number:
- 200-675-3
- EC Name:
- Trisodium citrate
- Cas Number:
- 68-04-2
- IUPAC Name:
- trisodium citrate
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, Stolzenseeweg 32-36, D-88353 Kisslegg, GERMANY
- Age at study initiation: 15 wk
- Weight at study initiation: 2.9-3.0 kg
- Housing: 1/ stainless steel cage
- Diet: standared diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1994-11-08 To: 1994-11-11
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eye is used as control in each case
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration: neat (crystaline powder) - Duration of treatment / exposure:
- Exposure from treatment to 72 h.
- Observation period (in vivo):
- 1, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): unwashed
SCORING SYSTEM: according to system given in OECD 405
TOOL USED TO ASSESS SCORE: hand-slit lamp and diagnostic lamp
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary Irritation Score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.11
- Max. score:
- 13
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Eye irritation score 0.11/13 (mean of 3 animals; 24, 48, 72h). Conjunctival redness (grade 2/3) and chemosis (grade 2-3/4) in 2 or 3 animals at 1h, chemosis (grade 1/4) in 1/3 animals at 24h. See also table 1.
- Other effects:
- No overt systemic toxicity or effect on body weight in observations up to 72 h.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Cornea |
Iris |
Conjunctiva |
||
Score at time point / Reversibility |
Redness |
Chemosis |
||
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
1 h |
0/0/0 |
0/0/0 |
0/2/2 |
1/2/3 |
24 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/1 |
48 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.11/13 |
|||
Reversibility* |
- |
- |
- |
c |
Time for reversion |
- |
- |
- |
48 h |
* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A reliable study, conducted according to OECD 405 and GLP, reported transient irritation and an overall score of 0.11 out of 13. The score was judged in the report to indicate that the test material was not irritating to the eyes of rabbits. This finding would concur with a reading according to EU criteria.
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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