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EC number: 242-734-6 | CAS number: 18996-35-5
- 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:
- from 8-11 November 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted according to the appropriate OECD test guideline and in compliance with GLP.
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:
- Sodium dihydrogen citrate
- EC Number:
- 242-734-6
- EC Name:
- Sodium dihydrogen citrate
- Cas Number:
- 18996-35-5
- Molecular formula:
- C6H8O7.Na
- IUPAC Name:
- dihydrogen sodium 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: 2.5-2.7 kg
- Housing: 1/stainless steel cage
- Diet: standard 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: 8 Nov 1994 To: 11 Nov 1994
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: 0.1 g
- Concentration: neat (crystaline powder) - Duration of treatment / exposure:
- Application without washing followed by observation for 72 h.
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: unwashed
SCORING SYSTEM: according to system given in OECD 405
TOOL USED TO ASSESS SCORE: 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:
- 1.56
- Max. score:
- 13
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- Conjunctival redness and chemosis in 2 or 3 animals at 1, 24, 48h. 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
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctiva |
|
Redness |
Chemosis |
|||
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
1 h |
0/0/0 |
0/0/0 |
2/3/2 |
3/3/3 |
24 h |
0/0/0 |
0/0/0 |
2/2/1 |
0/3/2 |
48 h |
0/0/0 |
0/0/0 |
1/1/1 |
0/1/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
1.56/13 |
|||
Reversibility* |
- |
- |
c |
c |
Time for reversion |
- |
- |
72 h |
72 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 Primary Irritation Score of 1.56/13. 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.
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