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EC number: 935-606-2 | CAS number: 1329658-14-1
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Endpoint summary
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- 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
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- Biotransformation and kinetics
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- Toxicological Summary
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- Acute Toxicity
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- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Acute oral median lethal dose (LD50 value) of NEXAMITE™ A56 (PET A) in Wistar rats was found to be >2000 mg/kg body weight.
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:
- April 17, 2014 to May 12, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- No further details specified in the study report.
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species: Rat (Rattus norvegicus)
Strain: Wistar
Age/Weight: at Dosing 8 to 9 weeks, Weight (g) Minimum: 167.4, Maximum: 189.5
Source: Animal Breeding Facility, Jai Research Foundation
Total Number of Animals Used: Twelve females
Female rats were nulliparous and non-pregnant.
The study was undertaken in compliance with the 'Guidelines for Laboratory Animals Facility' issued by the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), India. These guidelines promote the humane care of animals used in research by providing specifications that will enhance animal well being and experimental quality for the advancement of biological knowledge that is relevant to humans and animals.
Project proposal for the experimentation was approved by Institutional Animal Ethics Committee (IAEC), Jai Research Foundation.
JRF is also accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) that promotes the humane treatment of animals in science.
Acclimatisation
Acclimatisation Period 5 to 9 days
The rats were received into the experimental procedure room and allowed to acclimatise for a period of 5 days for set I rats (rat N° 1, 2 and 3), 7 days for set II rats (rat N° 4, 5 and 6), 9 days for set III rats (rat N° 7, 8 and 9) and 6 days for set IV rats (rat N° 10, 11 and 12) prior to commencement of dosing.
Husbandry Practices
Caging: Polypropylene rat cages covered with a stainless steel grid top were used. Autoclaved clean rice husk was used as the bedding material.
Water Bottle: Each cage was supplied with a polypropylene water bottle with a stainless steel nozzle.
Housing: Three rats per cage.
Room Sanitation: Daily: 1. Rack was cleaned with cloth. 2. Floor of experimental procedure room was swept. 3. All work tops and the floor were mopped with a disinfectant solution.
Animal Identification
Each rat was uniquely numbered on the tail using a tattoo machine. Appropriate labels were attached to the cages indicating the study number, test item code, set number and sex, dose, type of study, cage number and animal numbers.
Feed and Water
The rats were provided with feed (with the exception of overnight fasting prior to dosing and three hours post-dosing) and water, ad libitum. The quality of feed and water is regularly monitored at Jai Research Foundation. There were no known contaminants in the feed and water at levels that would have interfered with the experimental results obtained.
Feed: Teklad certified Global High Fiber Rat/Mice Feed manufactured by Harlan, U.S.A.
Water: UV sterilized water filtered through Kent Reverse Osmosis water filtration system.
Environmental Conditions
Environmental Temperature: 20 to 23 °C
Conditions Humidity: 65 to 66% relative humidity
Air Changes: Minimum 15 air changes/hour
Photoperiod: The photoperiod was 12 hours artificial light and 12 hours darkness, light hours being 06:00 h - 18:00 h, which was maintained through an automatic timer. - Route of administration:
- oral: gavage
- Vehicle:
- vegetable oil
- Details on oral exposure:
- The test item formed homogenous suspension in vegetable oil, so the actual dose formulation was prepared using vegetable oil as the vehicle. The required quantity (300 mg for set I and set II and 2000 mg for set III and set IV) was mixed with vegetable oil and the final volume was made up to 10 mL. Gavage solutions were prepared freshly within 2 hours prior to dosing on all occasions.
- Doses:
- 300 mg/kg bw (x 2 dose groups)
2000 mg/kg bw (x 2 dose groups) - No. of animals per sex per dose:
- 3 per dose group (12 in total)
- Control animals:
- no
- Details on study design:
- Dose Administration
Individual dose volume was adjusted according to body weight. All rats were dosed by gavage (day 0) using a metal cannula attached to a BD 1 mL disposable syringe which was graduated up to 1 mL.
Rats were fasted overnight prior to dosing until three hours post-dosing.
Main Study
A first set (set I) of three female rats was given a single dose of 300 mg/kg body weight NEXAMITETM A56 (PETA). No mortality was observed at this dose level so a second set (set II) of three female rats was administered with same dose of 300 mg/kg body weight NEXAMITE TM A56 (PETA). No mortality was observed at this dose level so a third set (set III) of three female rats was administered with a higher dose level of 2000 mg/kg body weightNEXAMITETM A56 (PETA). No mortality was observed at this dose level so a fourth set (set IV) of three female rats was administered with same dose of 2000 mg/kg body weight NEXAMITE TM A56 (PET A). No mortality was observed at this dose level hence the endpoint was achieved and further testing was not required.
Observations
The rats were observed for signs of toxicity and mortality at 0.5, 1, 2, 3, 4 and 6 hours postadministration on the day of dosing. Subsequently, the rats were observed twice a day for morbidity and mortality for a period of 14 days following oral dosing. The clinical signs were recorded once a day.
Individual body weight was recorded prior to dosing on day O and on days 7 and 14.
Necropsy
Surviving rats at the end of the 14-day observation period were euthanised by carbon dioxide asphyxiation and subjected to a gross pathological examination consisting of an external examination and opening of abdominal and thoracic cavities. Gross macroscopic changes, if any, were recorded. - Statistics:
- Not specified
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in rats treated at the dose level of 300 and 2000 mg/kg body weight NEXAMITE™ A56 (PETA).
- Clinical signs:
- other: No clinical sign was observed in rats treated with 300 and 2000 mg/kg body weight NEXAMITE™ A56 (PETA).
- Gross pathology:
- External: External examination of terminally sacrificed female rats did not reveal any abnormality of pathological significance.
Internal: Visceral examination of terminally sacrificed rats did not reveal any lesion of pathological significance. - Other findings:
- Not specified
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- No mortality was observed in rats treated at the dose level of 300 mg and 2000 mg NEXAMITE™ A56 (PETA)/kg body weight. The acute oral median lethal dose (LD50 cut-off value) of NEXAMITE™ A56 (PETA) in Wistar rats was found to be 5000 mg/kg body weight.
- Executive summary:
In an acute oral toxicity study, four sets of fasted Wistar rats (3 females/set) were given a single oral dose of NEXAMITE™ A56 (PETA) at a dose of300 (for each set I and set II) and 2000 (for each set III and set IV) mg/kg body weight and were observed for 14 days.
No clinical signs or mortalities were observed in rats treated with 300 mg/kg (set I and set II) and 2000 mg/kg body weight (set III and set IV) NEXAMITE™ A56 (PETA).
Normal gain in body weight was observed in all the rats.
All the rats at termination were subjected to gross pathological examination. External examination and visceral examination of the terminally sacrificed rats did not reveal any lesion of pathological significance. In the absence of any pathological lesion in terminally sacrificed rats, it is concluded that the test item did not produce any treatment related effect at the dose level used in the present study.
"The acute oral median lethal dose (LD50 value) of NEXAMITE™ A56 (PET A) in Wistar rats was found to be >2000 mg/kg body weight" and then follow with "The acute median lethal dose (LD50 cut-off value) of NEXAMITE TM A56 (PETA) in Wistar rats was found to be 5000 mg/kg body weight".
Based on the results of this study, an indication of the classification for NEXAMITE™ A56 (PETA) is as follows:
Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2013): Category 5 or Unclassified
Reference
Dose, Mortality/Animals Treated
Dose (mg/kg body weight) |
Female rats (mortality/total) |
300 |
0/6 |
2000 |
0/6 |
Mortality
Sex: Female
Dose (mg/kg body weight) |
Set No |
Number of Rats Used |
Mortality after Dosing |
||||||
At Hour |
On Day |
||||||||
½ - 4 |
6 |
1 |
2 |
3 |
4 – 7 |
8 – 14 |
|||
300 |
I |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
II |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2000 |
III |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IV |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Individual and Mean Body Weight (g) and Body Weight Change (%)
Sex: Female
Dose (mg/kg body weight) |
Rat No |
Body Weight (g) on Day |
Percent Body Weight Change on Day |
|||
0 |
7 |
14 |
7 |
14 |
||
300 |
1 |
171.2 |
195.7 |
222.3 |
14.31 |
29.85 |
2 |
167.4 |
192.4 |
213.8 |
14.93 |
27.72 |
|
3 |
171.3 |
194.6 |
207.3 |
13.60 |
21.02 |
|
Mean |
170.0 |
194.2 |
214.5 |
14.28 |
26.20 |
|
Standard Deviation |
±2.2 |
±1.7 |
±7.5 |
±0.67 |
±4.61 |
|
4 |
178.2 |
205.1 |
218 |
15.10 |
22.33 |
|
5 |
173.4 |
198.3 |
205.3 |
14.36 |
18.40 |
|
6 |
171.9 |
199.8 |
220.0 |
16.23 |
27.98 |
|
Mean |
174.5 |
201.1 |
214.4 |
15.23 |
22.90 |
|
Standard Deviation |
±3.3 |
±3.6 |
±8.0 |
±0.94 |
±4.82 |
|
2000 |
7 |
176.0 |
200.1 |
212.3 |
13.69 |
20.63 |
8 |
180.6 |
204.0 |
216.4 |
12.96 |
19.82 |
|
9 |
168.6 |
191.6 |
202.7 |
13.64 |
20.23 |
|
Mean |
175.1 |
198.6 |
210.5 |
13.43 |
20.23 |
|
Standard Deviation |
±6.1 |
±6.3 |
±7.0 |
±0.41 |
±0.41 |
|
10 |
182.8 |
200.1 |
218.5 |
9.46 |
19.53 |
|
11 |
188.9 |
210.4 |
230.8 |
11.38 |
22.18 |
|
12 |
189.5 |
213.8 |
232.4 |
12.82 |
22.64 |
|
Mean |
187.1 |
208.1 |
227.2 |
11.22 |
21.45 |
|
Standard Deviation |
±3.7 |
±7.1 |
±7.6 |
±1.69 |
±1.68 |
Key: 0 = Before dosing
Individual Clinical Observations
Sex: Female Set I
Dose (mg/kg body weight) |
Rat No |
Clinical Signs Observed Post-dosing |
|||||
At Hour (Day 0) |
|||||||
0.5 |
1 |
2 |
3 |
4 |
6 |
||
300 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
Dose (mg/kg body weight) |
Rat No |
Clinical Signs Observed Post-dosing |
|||||||||||||
On Days |
|||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
300 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Set II
Dose (mg/kg body weight) |
Rat No |
Clinical Signs Observed Post-dosing |
|||||
At Hour (Day 0) |
|||||||
0.5 |
1 |
2 |
3 |
4 |
6 |
||
300 |
4 |
1 |
1 |
1 |
1 |
1 |
1 |
5 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
1 |
1 |
1 |
1 |
1 |
1 |
Dose (mg/kg body weight) |
Rat No |
Clinical Signs Observed Post-dosing |
|||||||||||||
On Days |
|||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
300 |
4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Key: 1 = normal
Note: Day 0 = Day of dosing
Sex: Female Set III
Dose (mg/kg body weight) |
Rat No |
Clinical Signs Observed Post-dosing |
|||||
At Hour (Day 0) |
|||||||
0.5 |
1 |
2 |
3 |
4 |
6 |
||
2000 |
7 |
1 |
1 |
1 |
1 |
1 |
1 |
8 |
1 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
Dose (mg/kg body weight) |
Rat No |
Clinical Signs Observed Post-dosing |
|||||||||||||
On Days |
|||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
7 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
8 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Set IV
Dose (mg/kg body weight) |
Rat No |
Clinical Signs Observed Post-dosing |
|||||
At Hour (Day 0) |
|||||||
0.5 |
1 |
2 |
3 |
4 |
6 |
||
2000 |
10 |
1 |
1 |
1 |
1 |
1 |
1 |
11 |
1 |
1 |
1 |
1 |
1 |
1 |
|
12 |
1 |
1 |
1 |
1 |
1 |
1 |
Dose (mg/kg body weight) |
Rat No |
Clinical Signs Observed Post-dosing |
|||||||||||||
On Days |
|||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
10 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
11 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
12 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Key: 1 = normal
Note: Day 0 = Day of dosing
Individual Necropsy Findings
Sex: Female
Dose (mg/kg body weight) |
Set No |
Rat No |
Mode of Death |
External |
Internal |
300 |
I |
1 |
Terminal sacrifice |
No abnormalities detected |
No abnormalities detected |
2 |
Terminal sacrifice |
No abnormalities detected |
No abnormalities detected |
||
3 |
Terminal sacrifice |
No abnormalities detected |
No abnormalities detected |
||
II |
4 |
Terminal sacrifice |
No abnormalities detected |
No abnormalities detected |
|
5 |
Terminal sacrifice |
No abnormalities detected |
No abnormalities detected |
||
6 |
Terminal sacrifice |
No abnormalities detected |
No abnormalities detected |
||
2000 |
III |
7 |
Terminal sacrifice |
No abnormalities detected |
No abnormalities detected |
8 |
Terminal sacrifice |
No abnormalities detected |
No abnormalities detected |
||
9 |
Terminal sacrifice |
No abnormalities detected |
No abnormalities detected |
||
IV |
10 |
Terminal sacrifice |
No abnormalities detected |
No abnormalities detected |
|
11 |
Terminal sacrifice |
No abnormalities detected |
No abnormalities detected |
||
12 |
Terminal sacrifice |
No abnormalities detected |
No abnormalities detected |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- K1
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
In an acute oral toxicity study, four sets of fasted Wistar rats (3 females/set) were given a single oral dose of NEXAMITE™ A56 (PETA) at a dose of 300 (for each set I and set II) and 2000 (for each set III and set IV) mg/kg body weight and were observed for 14 days.
No clinical signs or mortalities were observed in rats treated with 300 mg/kg (set I and set II) and 2000 mg/kg body weight (set III and set IV) NEXAMITE™ A56 (PETA).
Normal gain in body weight was observed in all the rats.
All the rats at termination were subjected to gross pathological examination. External examination and visceral examination of the terminally sacrificed rats did not reveal any lesion of pathological significance. In the absence of any pathological lesion in terminally sacrificed rats, it is concluded that the test item did not produce any treatment related effect at the dose level used in the present study.
"The acute oral median lethal dose (LD50 value) of NEXAMITE™ A56 (PET A) in Wistar rats was found to be >2000 mg/kg body weight" and then follow with "The acute median lethal dose (LD50 cut-off value) of NEXAMITE TM A56 (PETA) in Wistar rats was found to be 5000 mg/kg body weight".
Justification for classification or non-classification
Based on the results of this study, an indication of the classification for NEXAMITE™ A56 (PETA) is as follows: Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2013): Category 5 or Unclassified
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.