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EC number: - | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Compliance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species/strain: healthy rats, WISTAR rats Crl: WI(Han) (full barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: female, non-pregnant, nulliparous
Number of animals:3 per step
Age
at the beginning of the study: 8 - 12 weeks old
Body weight
on the day of administration: Step 1 / animals no. 1 - 3: 177 – 187 g
Step 2 / animals no. 4 - 6: 142 – 162 g
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
Environmental Conditions:
Full barrier in an air-conditioned room
Temperature: 22 ± 3 °C
Relative humidity: 55± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: 10 x / hour
Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 0815)
Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 110811)
Certificates of food, water and bedding are filed at BSL BIOSERVICE
Adequate acclimatisation period (at least five days) under laboratory conditions
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Dose Administration:
The test item was administered at a single dose by gavage using a feeding tube.
The test item was administered at a dose volume of 10 mL/kg body weight.
Preparation of Dose Formulation:
For all animals of both steps, 2 g of the test item were dissolved in the vehicle to gain a final volume of 10 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight. - Doses:
- The starting dose was selected to be 2000 mg/kg body weight. No compound-related mortality was recorded for any animal of step 1 or 2. Based on these results and according to the acute toxic class method regime no further testing was required.
- No. of animals per sex per dose:
- 3 animals per step (2 steps were used)
- Control animals:
- no
- Details on study design:
- Preparation of the Animals:
The animals were marked for individual identification by tail painting.
Prior to the administration a detailed clinical observation was made of all animals.
Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted). Following the period of fasting the animals were weighed and the test item was administered. Food was provided again approximately 4 hours post dosing.
Observation Period:
All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.
Weight Assessment:
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
Clinical Examination:
A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.
Pathology:
At the end of the observation period the animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally (Narcoren®, Merial; lot no.: 215061; expiry date: 06/2014) at a dosage of approximately 8 mL/kg bw.
All animals were subjected to gross necropsy. All gross pathological changes were recorded.
Evaluation of Results:
Results were interpreted according to OECD Guideline 423, Annex 2 (see also flow charts in the appendix of the study plan).
Individual reactions of each animal were recorded at each time of observation.
Toxic response data were recorded by dose level.
Nature, severity and duration of clinical observations were described.
Body weight changes were summarised in tabular form.
Necropsy findings were described.
On the basis of the test results, the test substance may be classified in any of the following classes in conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC :
• Very toxic
Substances and preparations shall be classified as very toxic, and assigned the symbol “T+” and indication of danger “very toxic” in accordance with the criteria specified below:
R28 Very toxic if swallowed
- LD50 oral, rat ≤ 25 mg/kg
- less than 100% survival at 5 mg/kg oral, rat by the fixed dose procedure, or
- high mortality at doses ≤ 25 mg/kg oral, by the acute toxic class method.
• Toxic
Substances and preparations shall be classified as toxic, and assigned the symbol “T” and indication of danger “toxic” in accordance with the criteria specified below. Risk phrases shall be assigned in accordance with the following criteria:
R25 Toxic if swallowed
- LD50 oral, rat 25 < LD50 ≤ 200 mg/kg
- discriminating dose, oral rat 5 mg/kg: 100% survival but evident toxicity, or
- high mortality in the dose range > 25 to ≤ 200 mg/kg oral, rat, by the acute toxic class method.
• Harmful
Substances and preparations shall be classified as harmful, and assigned the symbol “Xn” and indication of danger “harmful” in accordance with the criteria specified below. Risk phrases shall be assigned in accordance with the following criteria:
R22 Harmful if swallowed
- LD50 per oral, rat 200 < LD50 ≤ 2000 mg/kg
- discriminating dose, oral rat, 50 mg/kg: 100% survival but evident toxicity,
- less than 100% survival at 500 mg/kg, rat oral by the fixed dose procedure, or
- high mortality in the dose range > 200 to ≤ 2000 mg/kg oral, rat, by the acute toxic class method.
On the basis of the test results, the following risk phrases may be assigned in conformity with the criteria given in Annex I of Regulation (EC) 1272/2008 :
Category 1: LD50 ≤ 5 mg/kg. DANGER. Skull and crossbones in diamond. Fatal if swallowed.
Category 2: LD50 > 5 mg/kg ≤ 50 mg/kg. DANGER. Skull and crossbones in diamond. Fatal if swallowed.
Category 3: LD50 > 50 mg/kg ≤ 300 mg/kg. DANGER. Skull and crossbones in diamond. Toxic if swallowed.
Category 4: LD50 > 300 mg/kg ≤ 2000 mg/kg. WARNING. Exclamation point in diamond. Harmful if swallowed.
On the basis of the test results, the following risk phrases may be assigned in conformity with the criteria given in GHS - Globally Harmonized System of Classification and Labelling of Chemicals, third revised edition, July 2009:
Category 1: LD50 ≤ 5 mg/kg
DANGER. Skull and crossbones in diamond. Fatal if swallowed.
Category 2: LD50 > 5 mg/kg ≤ 50 mg/kg
DANGER. Skull and crossbones in diamond. Fatal if swallowed.
Category 3: LD50 > 50 mg/kg ≤ 300 mg/kg.
DANGER. Skull and crossbones in diamond. Toxic if swallowed.
Category 4: LD50 > 300 mg/kg ≤ 2000 mg/kg.
WARNING. Exclamation point in diamond. Harmful if swallowed.
Category 5: LD50 > 2000 mg/kg ≤ 5000 mg/kg.
WARNING. No symbol. May be harmful if swallowed.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No Mortality was observed in this study.
- Clinical signs:
- other: One of six animals (animal No. 6) showed clinical signs on the day of application, which were slightly reduced spontaneous activity, slight piloerection, half eyelid-closure.
- Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.
Any other information on results incl. tables
Clinical Signs:
Animal |
Time of |
Observations
|
Step 1 (2000 mg/kg Body Weight) |
||
1 / female |
during the whole observation period |
no signs of toxicity |
2 / female |
during the whole observation period |
no signs of toxicity |
3 / female |
during the whole observation period |
no signs of toxicity |
Step 2 (2000 mg/kg Body Weight) |
||
4 / female |
during the whole observation period |
no signs of toxicity |
5 / female |
during the whole observation period |
no signs of toxicity |
6 / female |
30 min |
no signs of toxicity |
1 h |
slightly reduced spontaneous activity, |
|
2 h |
slightly reduced spontaneous activity, |
|
3 h, 4 h |
slight piloerection |
|
d 2 until the end of the observation period |
no signs of toxicity |
d = day; day 1 = day of administration, h = hour/s, min = minute/s
Body Weight Development:
Animal No. / |
g |
g |
g |
% |
Step 1 (2000 mg/kg Body Weight) |
||||
1 / female |
177 |
195 |
199 |
12 |
2 / female |
187 |
214 |
216 |
16 |
3 / female |
182 |
199 |
208 |
14 |
Step 2 (2000 mg/kg Body Weight) |
||||
4 / female |
162 |
179 |
187 |
15 |
5 / female |
162 |
183 |
198 |
22 |
6 / female |
142 |
159 |
174 |
23 |
Pathology:
Animal No./ |
Organ |
Macroscopic Findings |
Step 1 (2000 mg/kg Body Weight) |
||
1 / female |
- |
nsf |
2 / female |
- |
nsf |
3 / female |
- |
nsf |
Step 2 (2000 mg/kg Body Weight) |
||
4 / female |
- |
nsf |
5 / female |
- |
nsf |
6 /female |
- |
nsf |
nsf = no specific findings
LD50 Cut-Off:
Dose |
Number of |
Number of Intercurrent Deaths |
LD50 Cut-Off |
2000 mg/kg bw |
6 |
0 |
5000 mg/kg bw |
bw = body weight
Applicant's summary and conclusion
- Interpretation of results:
- relatively harmless
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the conditions of the present study, a single oral application of the test item FAT 40858/A TE to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity.
The median lethal dose of FAT 40858/A TE after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): 5000 mg/ kg bw
LD50: >2000 mg/kg bw
In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item FAT 40858/A TE has no obligatory labelling requirement for toxicity.
According to Annex I of Regulation (EC) 1272/2008 the test item FAT 40858/A TE has no obligatory labelling requirement for toxicity and is not classified.
According to GHS (Globally Harmonized Classification System) the test item FAT 40858/A TE has obligatory labelling requirement for toxicity and is classified into Category 5. - Executive summary:
Two steps, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was dissolved in the vehicle aqua ad injectionem (sterile water) at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg body weight.
All animals used in the study after their arrival at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15.All animals were necropsied and examined macroscopically.
Results per Step:
Step
Sex/No.
Dose (mg/kg)
Number of Animals
Number of Intercurrent Deaths
1
female/1-3
2000
3
0
2
female/4-6
2000
3
0
All animals survived until the end of the study. Only one of six animals showed signs of toxicity.
The clinical findings in this animal treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, piloerection and half eyelid-closure. These signs are considered to be common symptoms in acute oral toxicity tests.
Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain.
At necropsy, no macroscopic findings were observed in any animal of any step.
On the basis of the test results given below and in conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC, the substance should be:
not classified
X
limit test
X
On the basis of the test results given below and in conformity with the criteria given inAnnex I of Regulation (EC) 1272/2008, the substance should be:
not classified
X
On the basis of the test results given below and in conformity with the criteria given inGHS (Globally Harmonized System of Classification and Labelling of Chemicals), the substance should be:
classifiedinto category 5
X
LD50cut-off: 5000 mg/kg bw
LD50: >2000 mg/kg bw
Species/strain: WISTAR Crl: WI(Han) rats
Number of animals: 3 per step / 2 steps performed
Vehicle: aqua ad injectionem
Method: OECD 423
EC 440/2008, Method B.1 tris
OPPTS 870.1000
OPPTS 870.1100
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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