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EC number: 285-503-5 | CAS number: 85114-00-7
- 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
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- 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
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- Repeated dose toxicity
- Genetic toxicity
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- Specific investigations
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- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
The substance is of low acute toxicity in mammals by both the oral and dermal routes.
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:
- 3 July to 25 July 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study carried out according to OECD Guideline 401 (1987); performed according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Name of test material (as cited in study report): SER-AD FX 511
- Physical state: liquid
- Analytical purity: no data; identity, purity and stability of the test material were the responsibility of the sponsor
- Storage condition of test material: room temperature - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Ltd., Margate, Kent, UK
- Age at study initiation: 5 -8 w
- Weight at study initiation: 145-155 g (males), 135-147 g (females)
- Fasting period before study: overnight before dosing
- Housing: groups of up to five animals of the same sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 47-66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE: no vehicle was used; dose volume applied: 2.15 ml/kg
- Rationale for the selection of the starting dose: a range-finding test was conducted initially so as to determine the appropriate dose for the main study. Two animals ( one male, one female) were treated orally by gavage with a dose of 2000 mg/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for mortality and clinical signs of toxicity 0.5, 1, 2 and 4 h post-treatment, and once per day for the whole observation period. Body weights were recorded on day 0, 4, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathological examination - Statistics:
- Not used, not necessary for such a type of study.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Range-finding study: no death of animals occured. Hunched posture and lethargy were observed, which returned to normal 1 day post-treatment. Hence, the dose of 2000 mg/kg bw was chosen for the main study.
Main study: no animal died during after administration of the test substance - Clinical signs:
- other: Hunched posture, lethargy and ataxia were observed post-treatment. The animals appeared normal 1 day after dosing. Decreased reaspiratory rate was recorded in one male 2-4 hours after administration of the test material, which was reversible and was not o
- Gross pathology:
- No treatment-related abnormalities were detected in any of the animals tested in the post-moterm examinations.
- Other findings:
- - Organ weights: not recorded
- Histopathology: not performed due to no detected abnormalities in the gross pathological examination - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is of a low order of toxicity following a single oral exposure of rats. The LD50 is >2000mg/kg bw.
- Executive summary:
In an acute oral toxicity study, groups of overnight fasted, young adult Sprague-Dawley CD rats 5/sex/dose, were given a single oral dose (by gavage) of 2000 mg/kg bw SER-AD FX 511 (unchanged) and were observed for 14 days. The dose was decided based on a prior-range finding study. The test material was found to be of a low order of acute toxicity following exposure of rats. No mortality was observed. The LD50 for both male and female rats is higher than 2000 mg/kg bw. Clinical signs on the day of dosing included hunched posture, ataxia and lethargy. One animal showed decreased respiratory rate. All clinical symptomps disappeared on day 1 after treatement. All animals except had gained weight 7 and 14 days following dosing. The post-moterm examination revealed no signs of adverse effects. On the basis of this study, SER- AD FX 511 does not warrant classification as being harmful or toxic.
Reference
Table 1: Individual body weights and weekly body weigh changes in the main study
Dose level (mg/kg bw) |
Animal No |
Body weight (g) at day |
Body weight gaing (g) during week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
Males |
|||||
1 |
146 |
195 |
233 |
49 |
38 |
|
2 |
145 |
196 |
244 |
51 |
48 |
|
3 |
155 |
221 |
280 |
66 |
59 |
|
4 |
155 |
216 |
270 |
61 |
54 |
|
5 |
155 |
219 |
281 |
64 |
62 |
|
Females |
||||||
1 |
135 |
175 |
206 |
40 |
31 |
|
2 |
142 |
172 |
200 |
30 |
28 |
|
3 |
145 |
181 |
209 |
36 |
28 |
|
4 |
147 |
186 |
207 |
39 |
21 |
|
5 |
141 |
174 |
198 |
33 |
24 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Sufficient to meet data requirements. The study is Klimisch 1.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Sufficient to meet data requirements. The study is Klimisch 1.
Additional information
The substance is of low acute toxicity in mammals by both the oral and dermal routes.The acute oral LD50 is > 2000 mg/kg while the acute dermal LD50 is > 2000 mg/kg. Testing by the inhalation route is not scientifically justified.
Justification for selection of acute toxicity – oral endpoint
Only one study available.
Justification for selection of acute toxicity – inhalation endpoint
An acute inhalation toxicity study is scientifically unjustified and is not in the interests of animal welfare. Acute studies are available by the oral and dermal routes.
Justification for selection of acute toxicity – dermal endpoint
Only one study available.
Justification for classification or non-classification
Given the available LD50 values, the substance does not meet the criteria for classification for acute toxicity by either the oral or dermal routes.
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