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EC number: 212-755-5 | CAS number: 866-84-2
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2-29 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 very largely in compliance with GLP. The study is a read accross from sodium citrate (CAS 68-04-2).
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 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan Spotted (Ibm:GOHI)
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd, Wölferstrasse 4, 4414 Fűllinsdorf/Switzerland
- Age at study initiation: 5-7 wk
- Weight at study initiation: 311-452 g (start of acclimatization)
- Housing: 1/Makrolon type 3 cage, autoclaved standard softwood bedding
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 1 wk
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 50-74 (OECD guideline recommends 30-70%)
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1994-11-02 To: 1994-11-29
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction: intradermal injections 5% TS (with Freund's Complete Adjuvant in some cases); epicutaneous 10% SLS followed by 75% TS.
Challenge: 75, 50 & 25% TS.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: intradermal injections 5% TS (with Freund's Complete Adjuvant in some cases); epicutaneous 10% SLS followed by 75% TS.
Challenge: 75, 50 & 25% TS.
- No. of animals per dose:
- 20 test animals, 10 vehicle controls, 2x10 positive controls
- Details on study design:
- RANGE FINDING TESTS:
Intradermal tests with 2 animals: 0.1 ml/site; 1, 3 and 5% TS in bidistilled water; evaluated at 24 h. 5% TS was selected
Epicutaneous tests with 4 animals: 2 cm x 2 cm saturated with 75, 50, 25 or 15% solutions of TS in bidistilled water, covered with aluminium foil, elastic plaster and impervious adhesive tape; 24-h contact; evaluation 24 h and 48 h after removal of dressing. 75% TS was selected for induction and challenge, and 50% and 25% were also selected for challenge.
The highest concentration tested, 75%, "was found to be the most qualified to assure an optimum technical application procedure" - it is not clear what this means
MAIN STUDY
A. INDUCTION EXPOSURE
intradermal injections (day 1)
- No. of exposures: 3 pairs of injections (0.1 ml/site)
- Test group: 1:1 Freund's Complete Adjuvant (FCA) and physiological saline; 5% TS in bidistilled water; 5% TS in 1:1 FCA: physiological saline
- Control group: 1:1 FCA and physiological saline; bidistilled water; 1:1 bidistilled water and 1:1 FCA: physiological saline
- Site: within a 4x6 cm clipped area
day 7: 6x8 cm area clipped. As no irritation had been observed in the pretest this area was pretreated with 10% sodium lauryl sulfate (SLS) in paraffinum per liquidum to provoke a mild inflammatory reaction.
epidermal applications (day 8, scapular area)
- No. of exposures: 1 (2x4 cm saturated filter paper)
- Exposure period: 48 h
- Test group: 2x4 filter paper saturated with 75% TS in bidistilled water, covered with aluminium foil, elastic plaster and impervious adhesive tape
- Control group: as for test group using bidistilled water
- evaluation at 24 and 48 h following removal of dressing
B. CHALLENGE EXPOSURE (day 22, flank)
Flanks shaved
- No. of exposures: 4 concentrations, each applied on saturated 2x2 cm filter paper
- Exposure period: 24 h
- Test groups: 75%, 50%, 25% and 0% TS in bidistilled water
- Control group: 75%, 50%, 25% and 0% TS in bidistilled water
- Site: left and right, caudal and cranial flanks
- Concentrations: 75%, 50%, 25% and 0% TS in bidistilled water
- Evaluation (hr after challenge): 24 h and 48 h
- Challenge controls:
- Naive controls: group of 10 males treated as described above.
- Positive control substance(s):
- yes
- Remarks:
- 4-aminobenzoic acid ethyl ester (25 May to 27 June 1994); 2-mercaptobenzothiazol (25 May to 5 July 1994). Groups of 10 in each case.
Study design: in vivo (LLNA)
- Statistics:
- Mean and standard deviation for body weights.
Results and discussion
- Positive control results:
- Tests in the same strain of guinea pig using 4-aminobenzoic acid ethyl ester (25 May to 27 June 1994) and 2-mercaptobenzothiazol (25 May to 5 July 1994) (groups of 10 test and 4 or 5 controls; 25% in mineral oil in each case) found sensitization in 60% test animals and in none of the controls for both studies.
In vivo (non-LLNA)
Results
- Reading:
- other: readings at 24 and 48 h after challenge
- Group:
- test chemical
- Dose level:
- 25, 50 and 75% TS
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No clinical signs or effect on body weight detected
- Remarks on result:
- other: Reading: other: readings at 24 and 48 h after challenge. Group: test group. Dose level: 25, 50 and 75% TS. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No clinical signs or effect on body weight detected.
Any other information on results incl. tables
Table 1: Incidence of dermal response to challenge dosing
GROUP |
MATERIAL |
INTERVAL (AFTER 24 h CHALLENGE) |
SKIN REACTIONS (NUMBERS OF ANIMALS) |
NO. ANIMALS |
SENSITIZATION INCIDENCE INDEX* |
Test |
TS (75%) |
24 h |
0 |
20 |
0/20=0% |
48 h |
0 |
20 |
|||
TS (50%) |
24 h |
0 |
20 |
||
48 h |
0 |
20 |
|||
TS (25%) |
24 h |
0 |
20 |
||
48 h |
0 |
20 |
|||
Vehicle (bidistilled water) |
24 h |
0 |
20 |
0/20=0% |
|
48 h |
0 |
20 |
|||
Positive control (2-mercaptobenzothiazol) |
25% in vehicle |
24 h |
6 |
10 |
6/10=60%* |
48 h |
6 |
10 |
|||
Vehicle (mineral oil) |
24 h |
0 |
10 |
0/10 |
|
48 h |
0 |
10 |
|||
Positive controls (4-aminobenzoic acid ethyl ester) |
25% in vehicle |
24 h |
6 |
10 |
6/10=60%* |
48 h |
6 |
10 |
|||
Vehicle (mineral oil) |
24h |
0 |
10 |
0/10=0% |
|
48h |
0 |
10 |
|||
Negative (vehicle) control |
TS (75%) |
24 h |
0 |
10 |
n/a |
48 h |
0 |
10 |
|||
TS (50%) |
24 h |
0 |
10 |
||
48 h |
0 |
10 |
|||
TS (25%) |
24 h |
0 |
10 |
||
48 h |
0 |
10 |
|||
Vehicle (bidistilled water) |
24 h |
0 |
10 |
n/a |
|
48 h |
0 |
10 |
* A response of 30% or greater would indicate that a substance was a sensitizer
**The response of 60% in the positive controls confirms the sensitivity and reliability of the experimental technique
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The result was a read accross from sodium citrate (CAS 68-04-2). A well conducted, well reported guinea-pig maximization test failed to identify any sensitizing potential in tests involving a 75% concentration of the test material.
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