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EC number: 946-134-1 | CAS number: 164651-56-3
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- from March 21 to April 04, 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Acid Green 073:2
- IUPAC Name:
- Acid Green 073:2
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif:RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 175-210 g
- Fasting period before study: overnight
- Housing: caged in group of 5 in Macrolon cages type 4 (Société Parisienne des sciures, Pantin)
- Diet (e.g. ad libitum): ad libitum, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland)
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
- Doses:
- 5000 mg/kg body weight
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days or until symptoms have disappeared
- Frequency of observations and weighing: daily for mortality and sign or symptoms; on days 1, 7, 14 and at death for body weight
- Necropsy of survivors performed: yes - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No dead rats observed.
- Clinical signs:
- Dyspnoea, exophthalmus, ruffled fur and curved body position were seen. In addition, a transient diarrhoea was observed. The surviving animals recovered within 11 days.
- Gross pathology:
- No gross lesions were found at necropsy.
Any other information on results incl. tables
signs and symptoms
Observations |
Exposure day: hours |
Days of post-exposure period |
||||||||||||||||
1 |
2 |
3 |
5 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
>13 |
|
5000 mg/kg |
||||||||||||||||||
dyspnoea |
xx |
xx |
xx |
xx |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
|
|
|
|
exophthalmus |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
|
|
|
|
|
ruffled hair |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
|
|
|
|
|
|
diarrhoea |
|
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
body position curved |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
|
|
|
|
|
|
|
|
x=slight xx=moderate xxx=marked
body weights and standard deviations
|
males |
females |
||||
dose mg/kg |
day 1 |
day 7 |
day 14 |
day 1 |
day 7 |
day 14 |
5000 |
203 / 5.1 |
275 / 10.9 |
315 / 13.4 |
182 / 8.0 |
218 / 11.3 |
231 / 11.5 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 > 5000 mg/kg body weight.
- Executive summary:
Method
The test substance was tested for acute toxicity for oral route on rats following the OECD guideline 401. The strain chosen for the test was: Rat, Tif:RAIf, F3-crosses of RII 1/Tif x RII 2/Tif. They were caged in groups of 5 in Macrolon cages type 4 with food and water freely available.
Prior to dosing, the animals were fasted overnight. The animals were allocated to the different dose groups by random selection.
The test substance was administered orally by gastric intubation (gavage) at a dose level of 5000 mg/kg bw on 5 males and 5 females. The observation period was 14 days or until all symptoms have disappeared.
Spontaneously dying animals were submitted to a gross necropsy; survivors at the end of the observation period.
No deaths were observed during the exposure and post exposure period and no gross lesions were found at necropsy.
Results
The LD50 observed was higher than 5000 mg/kg bw.
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