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EC number: 800-036-4 | CAS number: 1422423-64-0
- 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
Endpoint summary
Administrative data
Description of key information
LD50 (oral) > 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January, from 14th to 28th, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- December 17th, 2001
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy breeding, S. Pietro al Natisone (UD).
- Weight at study initiation: 192 - 202 g.
- Housing: transparent polycarbonate cages (425 x 266 x 180 mm); animals were housed 5 per cage.
- Fasting period before study: test animals were fasted overnight before the beginning of the test. 4 hours after exposure, regular pellet diet was provided.
- Diet: pellet diet from Harlan Italy.
- Water: purified water, ad libitum.
- Quarantine: 5 days.
- Health check: the animals were subjected to a veterinary examination to ensure their suitability for the study.
ENVIRONMENTAL CONDITIONS
- Illumination: fluorescent light lamp.
- Photoperiod: 12 hours light and 12 hours dark. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: weekly weight control. Mortality, main organic functions evaluation, skin evaluation, mucous evaluation mobility and sensitivity evaluation were conducted at 30 min, at 2 and 4 hours and after 1, 2, 5, 6, 7, 8, 9, 12, 13 and 14 days of exposure.
- Necropsy of survivors performed: at the end of the study period. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed
- Clinical signs:
- During the test, all animals showed piloerection 4 hours after the exposure, tucked up abdomen 24 hours after the exposure.Those symptoms disappeared in two animals after 7 days from the test start, in three animals after 8 days from the test start.
- Body weight:
- A weight increase was observed in all test animals.
- Other findings:
- Two animals showed a moderate mucous enteritis and one animal showed a slight mucous enteritis.
- Interpretation of results:
- other: not classified, according to the CLP Regulation
- Conclusions:
- LD50 (rat female) > 2000 mg/kg bw
- Executive summary:
Method
Acute oral toxicity study of the test item in Sprague Dawley rats was performed according to the OECD Guidelines No. 420 - Acute Oral Toxicity – fixed dose. In the present study, conducted as a ‘limit test’, single oral administration of the test item was made to a single group of five female Sprague Dawley rats at the dose of 2000 mg/kg bw, to assess its acute toxicity, through oral gavage.
After 4 hours from the administration, the normal pellet diet was provided. Following their treatment, the rats were observed for incidence of mortality and signs of toxicity for 14 days and then sacrificed and subjected to a necropsy examination. The rats were observed for: mortality, main organic functions evaluation, skin evaluation, mucous evaluation, mobility and sensitivity evaluation. The body weight was weekly recorded.
Observations
When tested at the dose of 2000 mg/kg bw, the test item did not induce any mortality in any of the treated rats. The body weight gained by treated rats was lower than species and strain standard during the first week of the study, and not found to be adversely affected during the second week. At gross necropsy, 2 animals showed a moderate mucous enteritis and 1 animal showed a slight enteritis. During the study, all animals showed piloerection 4 hours after treatment and tucked up abdomen after 24 hours from the administration. These symptoms disappeared in 2 animals after 7 days from the test start, and after 8 days in the other 3 tested animals.
Results
Based on these results, and according to the criteria for classification of chemicals OECD 420 the test article, is not classified under CLP regulation.
Reference
Weight increase
Female N. | Weighed gain (g) |
1 | 13 |
2 | 10 |
3 | 10 |
4 | 16 |
5 | 16 |
Body weight of treated animals, registered at the test start, after 7 and after 14 days of treatment.
Female N. | Start (g) | Mid period (g) | End (g) |
1 | 197 | 199 | 210 |
2 | 202 | 203 | 212 |
3 | 200 | 203 | 210 |
4 | 195 | 198 | 211 |
5 | 192 | 195 | 208 |
X | 197.2 | 199.6 | 210.2 |
DS | 3.96 | 3.44 | 1.48 |
X= average
SD= standard deviation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
ACUTE ORAL TOXICITY
An acute oral toxicity study was conducted on the target chemical Set-Retard plus. The substance is expected to be biochemically stable and not bioavailable; it is expected to be mainly excreted as such, without interaction with the life-system. Because of the possibility of a partial metabolism/transformation of the substance cannot be excluded, the available information on possible precursors, which could be also the metabolites/transformation products of the target susbtance, has been precautionarly taken into account. The read across approach can be considered as reliable and appropriate for the endpoint under investigation; details on the read across approach are included in the reportattached to the IUCLID section 13.
Target Substance
In order to evaluate the acute toxicity by oral route of the target substance, an experimental study was conducted according to the OECD Guideline 420. During the test a single dose was administered by oral gavage to a five fimale group of Sprague Dawley rats (2000 mg/kg bw). Following their treatment, the rats were observed for incidence of mortality and signs of toxicity for 14 days and then sacrificed and subjected to a necropsy examination.
During the test no death occurred and no significative clinical signs were observed.
LD50 (rat female) > 2000 mg/kg bw
RA Substance 1a (succinic acid)
[Secondary source: OECD SIDS (2003) - Disodium Succinate CAS N°: 150-90-3. UNEP publications. Ref. KODAK, Company Reports]
Information are available from secondary source; unfortunately, only few details are reported. The substance was tested for acute oral exposure. No death observed at concentration of 2260 mg/kg bw, the effects observed are: weakness and diarrhea.
LD50 (rat male and female) > 2260 mg/kg bw
RA Substance 1b (monosodium succinate)
[Maekawa A. et al., (1990) Lack of toxicity/carcinogenicity of monosodium succinate in F344 rats; Food Chem. Toxicol. 28, 235 (1990)]
The acute oral toxicity of the substance, was examined in F344 rats. The test item was administered by gavage at dose of 500, 1000, 2000, 4000 and 8000 mg/kg bw.
At dose 8 g/kg one female rat died during the first week, all of the other rats survived until the end of the study. No clear toxicological effect was observed in rats that died or were killed, except for haemorrhage of the lung which was observed in some rats given the highest dose.
LD50 (rat male and female) > 8000 mg/kg bw
RA Substance 2b (L-lysine hydrochloride)
[Briglia R.J. et al., (1973) Effect of selected amino acids on ethanol toxicity in rats; Journal of Ppharmaceutical Sciences; Vol. 62, No.1, January 1973]
The substance has been tested for acute toxicity by oral route according to the Wilcoxon method. The rats were then subjected to the same neurological tests for signs of pharmacological effect.
LD50 (rat male and female): 10130 mg/kg bw
ACUTE INHALATION TOXICITY
Waiving – Exposure consideration
Taking into account the vapour pressure (VP = 0.00175 Pa) and the particle size distribution (10 % < 6.6 µm and 2.3 % < 2.0 µm) of the target substance, the exposure of humans via inhalation route is unlikely. Moreover, appropriate risk management measures and devices are implemented at the site(s) where the substance is manufactured and used, thus the possible occupational exposure and contact with the substance can be reduced at very low concentrations. General population can be considered not exposed to the substance.
ACUTE DERMAL TOXICITY
Waiving – Study scientifically unjustified
The physicochemical properties of the substance do not suggest potential for a significant rate of absorption through the skin. In the skin irritation test no adverse effects were seen and in the skin sensitisation assay no signs of systemic toxicity were recorded.
Furthermore, the substance is not acutely toxic by oral route, up to doses of 2000 mg/kg bw. Taking into account that the dermal absorption is commonly lower than the oral one, no systemic adverse effects are expected up to the same dose level by dermal route.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).
In the case of the oral route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:
- Category 1: ATE ≤ 5 mg/kg bw
- Category 2: 5 < ATE ≤ 50 mg/kg bw
- Category 3: 50 < ATE ≤ 300 mg/kg bw
- Category 4: 300 < ATE ≤ 2000 mg/kg bw
The acute oral LD50 in rats was established to be greater than 2000 mg/kg bw.
No data are available for acute dermal/inhalation toxicity, however no significant adverse effects are expected and no further investigations are required.
Therefore, the substance is not classified for oral acute toxicity, according to the CLP Regulation (EC 1272/2008).
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