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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:
- September 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17.12.2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Test material form:
- solid
- Details on test material:
- Test material was sublimed for purification.
Constituent 1
- Specific details on test material used for the study:
- Test Item: AM(pfa)4
Appearance: white powder
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female rats were used as recommended by the OECD TG 423 guideline. Test Animal Species: Wistar rats, sourced from Institute of Experimental Pharmacology and Toxicology, Center of Experimental Medicine of the Slovak Academy of Sciences, Dobrá Voda, Slovak Republic
Number and Sex of Animals used in study: 12 females
Age at First Dose: 8 - 12 weeks; female animals were non-pregnant and nulliparous; the health condition of animals was examined by a veterinarian before initiation of the study and animals were acclimated to the condition identical to the condition during the experiment at least 5 days prior to the start of treatment. The acclimation was according to standard operation procedures.
Housing Condition: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage, in a room equipped with central air-conditioning. The room temperature was maintained within the range of 22 ±2 °C. The relative humidity was 55 ±10 %. The light regime was set to a 12-hour light / 12-hour dark cycle. The sanitation was performed according to standard operation procedures.
Diet: A standard laboratory food KKZ-P/M (UEFT CEM SAS) was available ad libitum. The animals received tap water for human consumption. Supply of drinking water was unlimited. The quality of drinking water is periodical monitored (including microbiological control) and recorded.
Bedding: AlpenSpan Eco, Johann Pabst Holzindustrie GmbH, Zeltweg, Austria
Animals Identification: Each animal was marked with an ID number. Each cage was affixed with a cage card containing pertinent animal and study information. The animals in cages were marked by a line on the tail with an ink marker.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Aqua Pro Injectione Braun, B. Braun Melsungen AG, Germany, Lot Number 19144011
- Details on oral exposure:
- The required amount of the test item (according to the body weight and dose) was mixed with appropriate vehicle (Aqua pro injectione) shortly before administration. Dose was recalculated to concentration 100% of AM(pfa)4 (purity of test item was ˃ 96 %, typically 98.5 %). The test item was administered in a single dose by gavage using an oral gavage. Animals were fasted prior to dosing (food but not water was withheld over-night). Following the period of fasting, the animals were weighed and the test item was administered. After the test item administration, food was withheld for further 3 ‒ 4 hours.
The animals were observed individually immediately after the administration of the test item and then 0.5, 1, 2 and 4 hours later. Each animal was inspected daily for the next 14 days. Observations included: changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behavioural patterns. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Individual weights of animals were determined shortly before the test item administration and weekly thereafter. Weight changes after first and second week after administration were calculated and recorded.
All test animals were subjected to gross necropsy. All gross pathological changes were recorded for each animal. Examinations included: external body surface and orifices, the appearance of tissues and organs in the thoracic cavity (trachea, esophagus, heart, aorta, lungs with main stem bronchi, thymus, tracheobronchial lymph node) and in the abdominal cavity (liver, spleen, adrenal glands, kidneys, ovaries, uterus including cervix, urinary bladder, small intestine, large intestine, pancreas, stomach, mesenteric lymph nodes). - Doses:
- 2000 mg/kg bw, 300 mg/kg bw, 50 mg/kg bw
- No. of animals per sex per dose:
- 3 females per dose
- Control animals:
- no
- Details on study design:
- The starting dose was to be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. Available information indicated that the test item was likely to be non-toxic regarding acute toxicity; therefore, a dose of 2000 mg of AM(pfa)4 per kg body weight to be used as a starting dose was selected. In the first step, one group of 3 females was dosed. The test item in limit dose caused mortality of all three animals within 4 hours after administration. In a second step, 3 females were treated at dose of 300 mg/kg body weight. The test item at this dose level caused mortality of all three animals within 4 hours after administration. In a third step, 3 females were treated at a dose of 50 mg/kg body weight. Test item-related mortality was observed only in Animal No. 9 within 24 hours and therefore, in a fourth step, 48 hours later another 3 females were treated at the same dose level and no mortality was found.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 200 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality of 3/3 females at limit dose of 2000 mg/kg body weight and 3/3 females at the dose of 300 mg/kg body weight was observed. Five out of six female animals survived at the dose of 50 mg/kg body weight, and one animal died within 24 hours after administration. Summary results of clinical observations are presented in Tables 1 - 3.
- Clinical signs:
- other: Summary results of clinical observations are presented in Tables 1 - 3.
- Gross pathology:
- All animals were necropsied. No visible pathological findings were observed in animals dosed with 2000 and 300 mg/kg body weight. Similar findings were observed in Animal No 9, which died within 24 hours after administration of test substance. Necropsy of survived Animals 14 days after administration of test substance did not reveal any macroscopic findings (see Table 5).
Any other information on results incl. tables
Table 1. Clinical observation - 2000 mg/kg body weight, Animal No 1 - 3.
Observation |
Time After Administration |
||||||||||||||||||
|
Hour |
Day |
|||||||||||||||||
|
I |
0.5 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Skin and Hair** |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Eyes |
- |
- |
- |
- |
2 lacrim |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Mucosa |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Respiratory System* |
1,3 |
1,2,3 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Circulatory |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
System |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
CNS |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Somatomotoric Activity |
1,3 |
1,2,3 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Tremor |
1,3 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Spasms |
1,3 |
1,2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Salivation |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Diarrhoea |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Lethargy |
1,2,3 |
1,2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Sleep |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Coma |
- |
3 |
2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Death |
- |
3 |
1 |
- |
2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Sacrificed |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Others |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- No observed signs, I- immediately. * - dyspnoe, ** - piloerection
Sex |
Dose |
ID |
Administration Result |
Clinical Observation |
☿ |
2000 mg/kg |
1 |
death |
- lethargy and sleep/sedative behaviour, tremors and spasms immediately after administration of test item, coma after 1 hour and 2 hours later: death of animal |
2 |
death |
- lethargy and sleep/sedative behaviour, tremors and spasms immediately after administration of test item, coma after 2 hour and 4 hours later: death of animal, presence of lacrimation |
||
3 |
death |
- lethargy and sleep/sedative behaviour immediately after administration of test item, ½ an hour later: death of animal |
Table 2. Clinical observation - 300 mg/kg body weight, Animal No 4 - 6.
Observation |
Time After Administration |
||||||||||||||||||
|
Hour |
Day |
|||||||||||||||||
|
I |
0.5 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Skin and Hair** |
- |
4,5,6 |
4,5,6 |
4,5,6 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Eyes |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Mucosa |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Respiratory System* |
- |
- |
5 |
4,5,6 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Circulatory |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
System |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
CNS |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Somatomotoric Activity |
4,5,6 |
4,5,6 |
4,5,6 |
4,5,6 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Tremor |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Spasms |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Salivation |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Diarrhoea |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Lethargy |
4,5,6 |
4,5,6 |
4,5,6 |
4,5,6 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Sleep |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Coma |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Death |
- |
- |
- |
- |
4,5,6 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Sacrificed |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Others |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- No observed signs, I - immediately. * - dyspnoe, ** - piloerection
Sex |
Dose |
ID |
Administration Result |
Clinical Observation |
☿ |
300 mg/kg |
4 |
death |
- lethargy and somatomotor activity disturbances immediately after administration of test item, piloerection½an hour later, 1 hour later respiratory depression and 4 hours later death of animal |
5 |
death |
- lethargy and somatomotor activity disturbances immediately after administration of test item, piloerection ½ an hour later, 2 hours later respiratory depression and 4 hours after administration of test item death of animal |
||
6 |
death |
- lethargy and somatomotor activity disturbances immediately after administration of test item, piloerection ½ an hour later, 2 hours later respiratory depression and 4 hours after administration of test item death of animal |
Table 3. Clinical observation - 50 mg/kg body weight, Animal No 7 - 12.
Observation |
Time After Administration |
||||||||||||||||||
|
Hour |
Day |
|||||||||||||||||
|
I |
0.5 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Skin and Hair** |
- |
10,11,12 |
10,11,12 |
10,11,12 |
10,11,12 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Eyes |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Mucosa |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Respiratory System* |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Circulatory |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
System |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
CNS |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Somatomotoric Activity |
7,9 |
7,9 |
7,9 |
7,9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11 |
7,9 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
|
|
|
Tremor |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Spasms |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Salivation |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Diarrhoea |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Lethargy |
7,9 |
7,9 |
7,9 |
7,9 |
7,9 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Sleep |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Coma |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Death |
- |
- |
- |
- |
- |
9 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Sacrificed |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Others |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- No observed signs, I - immediately. * - dyspnoe, ** - piloerection
Sex |
Dose |
ID |
Administration Result |
Clinical Observation |
☿ |
50 mg/kg |
7 |
alive |
- lethargy and somatomotor activity disturbances immediately after administration of test item, which persisted for 4 hours. No other adverse reactions during 14-days observation period were observed. |
8 |
alive |
no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period |
||
9 |
death |
- lethargy and somatomotor activity disturbances immediately after administration of test item, which persisted for 4 hours. - 1 day after administration death of animal |
||
10 |
alive |
- piloerection ½ an hour after administration and persisted for 4 hours. No other adverse reactions during 14-days observation period were observed. |
||
11 |
alive |
- piloerection ½ an hour after administration and persisted for 4 hours, somatomotor activity disturbances observed 2 hours after. No other adverse reactions during 14-days observation period were observed. |
||
12 |
alive |
- piloerection ½ an hour after administration and persisted for 4 hours. No other adverse reactions during 14-days observation period were observed. |
Table 4. Body Weight
Sex |
Dose |
ID |
Body Weight (g) |
Body Weight Difference (g) |
||||
|
|
|
Initial |
Week 1 |
Week 2 |
Week 1 - Initial |
Week 2 - Initial |
Week 2 - Week 1 |
☿ |
2000 mg/kg |
1 |
165 |
- |
- |
- |
- |
- |
2 |
168 |
- |
- |
- |
- |
- |
||
3 |
160 |
- |
- |
- |
- |
- |
||
☿ |
300 mg/kg |
4 |
188 |
- |
- |
- |
- |
- |
5 |
178 |
- |
- |
- |
- |
- |
||
6 |
195 |
- |
- |
- |
- |
- |
||
☿ |
50 mg/kg |
7 |
177 |
182 |
198 |
5 |
21 |
16 |
8 |
203 |
218 |
237 |
15 |
34 |
19 |
||
9 |
175 |
- |
- |
- |
- |
- |
||
10 |
165 |
203 |
217 |
38 |
52 |
14 |
||
11 |
181 |
199 |
223 |
18 |
42 |
24 |
||
12 |
171 |
202 |
219 |
31 |
48 |
17 |
Table 5. Necropsy Results
Sex |
Dose |
ID |
Result |
☿ |
2000 mg/kg |
1 |
no pathological findings |
2 |
no pathological findings |
||
3 |
no pathological findings |
||
☿ |
300 mg/kg |
4 |
no pathological findings |
5 |
no pathological findings |
||
6 |
no pathological findings |
||
☿ |
50 mg/kg |
7 |
no pathological findings |
8 |
no pathological findings |
||
9 |
no pathological findings |
||
10 |
no pathological findings |
||
11 |
no pathological findings |
||
12 |
no pathological findings |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The LD50 of the test item AM(pfa)4 is greater than 50 mg/kg and lower than 300 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item AM(pfa)4 is classified GHS Category 3 with a LD50 cut off value 200 mg/kg body weight, after single oral administration to Wistar rats. - Executive summary:
The purpose of the study was to evaluate the potential toxic effect of the test item AM(pfa)4 when administered as a single oral dose to Wistar rats. The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.
A limit dose of 2000 mg/kg body weight was used as a starting dose. Available information indicated that the test item is likely to be non-toxic regarding acute toxicity; therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose. In the first step, one group of 3 females was dosed. The test item in limit dose caused mortality of all animals within 4 hours after administration. In a second step, 3 females were treated with dose of 300 mg/kg body weight. The test item in the dose of 300 mg/kg caused mortality of all animals within 4 hours after administration. In a third step, 3 females were treated with dose of 50 mg/kg body weight. The test item in dose 50 mg/kg caused death of Animal No 9 within the 24 hours. Animals No 7 and 8 survived and therefore another 3 females were treated 48 hours later at the same dose level and Animals No 10 - 12 survived.
The test item AM(pfa)4 administered to 3 females Wistar rats at a limit dose of 2000 mg/kg caused strong reaction immediately after administration of test item (tremor, spasm, breathing difficulties, coma). Within four hours all animals died. During necropsy no obvious pathological changes in gastrointestinal tract or other organs were observed.
The dose of 300 mg/kg of body weight caused immediate somatomotoric depression and lethargy with piloerection and breathing difficulties 1 hour after administration of test item. Within four hours all animals died. During necropsy no obvious pathological changes in gastrointestinal tract or other organs were seen.
The dose of 50 mg/kg caused death within 24h after administration of animal No 9, which preceded by lethargy and somatomotor disturbances. No other death at this dose was observed. During necropsy of animal No 9 no visible pathological changes were found. Necropsy of survived Animals 14 days after administration of test substance did not reveal any macroscopic findings at this dose level.
The LD50 of the test item AM(pfa)4 is greater than 50 mg/kg and lower than 300 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item AM(pfa)4 is classified GHS Category 3 with a LD50 cut off value 200 mg/kg body weight, after single oral administration to Wistar rats.
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