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EC number: 221-950-4 | CAS number: 3290-92-4
- 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)
Endpoint summary
Administrative data
Description of key information
Both oral and dermal acute toxicity studies were available on TMPTMA. Oral and dermal LD50 are higher than 2000 mg/kg bw in rats.
An acute toxicity study is available by intraperitoneal route: the ip LD50 for propylidynetrimethyl trimethacrylate is 3900 mg/kg bw in male and female rats.
No study is available by inhalation but this route of exposure does not need to be further investigated in accordance with Annex VIII of REACH.
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:
- From 05 May to 11 June 2010
- 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)
- Version / remarks:
- adopted 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HsdHan:WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, UK
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation: from 195 to 229 g
- Fasting period before study: overnight prior to dosing until 3 h after dosing
- Housing: in groups of up to five during the acclimatisation period. From the day prior to dosing (Day –1), the rats were housed in groups of three.
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No 1 (Special Diets Services Ltd, Witham, UK ), ad libitum except during fasting period
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: 21 to 23 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Air changes (per hr): 15 to 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 25 May 2010 To: 11 June 2010 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Volume applied: 1.82 mL/kg
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were recorded immediately post dose, at approximately 15 and 30 minutes post dose, hourly between 1 and 4 hours post dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Rats were weighed on Day 1 (day before dosing) and on Days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes - Statistics:
- None
- Preliminary study:
- No data
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No clinical signs were seen.
- Gross pathology:
- Red foci on the thymus, a large mandibular lymph node and red foci on the mandibular lymph node were noted at necropsy on one animal.
No abnormalities were noted at necropsy of all other animals. - Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 for propylidynetrimethyl trimethacrylate is higher than 2000 mg/kg bw in rats.
- Executive summary:
In an acute oral class method toxicity study performed in accordance with GLP and OECD guideline 423, 6 Sprague Dawley female rats were given a single oral dose of propylidynetrimethyl trimethacrylate at the limit test dose of 2000 mg/kg bw.
Clinical signs were recorded immediately post dose, at approximately 15 and 30 minutes post dose, hourly between 1 and 4 hours post dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Rats were weighed on Day 1 (day before dosing) and on Days 1, 4, 8 and 15.
No mortality, no clinical signs, no change in body weight and no abnormalities in macroscopic examination of main organs were observed except red foci on the thymus, a large mandibular lymph node and red foci on the mandibular lymph node in one animal.
The oral LD50 for propylidynetrimethyl trimethacrylate is higher than 2000 mg/kg bw in rats therefore it is not classified according to the CLP Regulation (EC) N° 1272-2008.
Reference
Table 1: Individual body weights and weekly increments
Dose level (mg/kg bw) |
Animal number |
Body weight (g) at: |
Increment (g) |
|||||
Day -1 |
Day 1 |
Day 4 |
Day 8 |
Day 15 |
Day 1 to 8 |
Day 8 to 15 |
||
2000 |
40 |
195 |
183 |
189 |
204 |
208 |
21 |
4 |
41 |
229 |
217 |
220 |
244 |
257 |
27 |
13 |
|
42 |
208 |
195 |
200 |
218 |
229 |
23 |
11 |
|
2000 |
43 |
209 |
201 |
209 |
215 |
225 |
14 |
10 |
44 |
214 |
200 |
211 |
217 |
232 |
17 |
15 |
|
45 |
216 |
208 |
217 |
221 |
236 |
13 |
15 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The oral acute study is considered to be reliable, and was performed according to the OECD guidelines.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 25 May to 16 June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted 24 February 1987
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HsdHan:WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, UK
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: from 279 to 344 g (males) and from 186 to 201 g (females)
- Housing: in groups of up to five during the acclimatisation period. From the day prior to dosing (Day –1), the rats were housed individually.
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No 1 (Special Diets Services Ltd, Witham, UK ), ad libitum
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: 21 to 23 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Air changes (per hr): 15 to 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 25 May 2010 To: 16 June 2010 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsum
- % coverage: 10 % of total body surface
- Type of wrap if used: A dense gauze patch was placed over the treated skin and retained in place by an elasticated, open-weave, adhesive compression bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): . The dermal test site of each rat was lightly brushed clean of any solid residues and swabbed with water-moistened cotton wool.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.82 mL/kg
- Constant concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were recorded immediately post dose, at approximately 15 and 30 minutes post dose, hourly between 1 and 4 hours post dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Individual records of clinical signs were maintained for each treated rat. Rats were weighed on Day 1 (day before dosing) and on Days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes
- One male and one female were used for preliminary test (results included in the main test) - Statistics:
- None
- Preliminary study:
- No mortality found.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality found.
- Clinical signs:
- other: There were no clinical signs of reaction to treatment. No dermal reactions were noted.
- Gross pathology:
- Red foci on the thymus, red foci on the mandibular lymph nodes and pale kidneys were noted at necropsy of in one male. Large mandibular lymph nodes and pelvic dilatation of the kidneys were noted in one female.
No macroscopic changes were observed at necropsy of all other animals. - Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, propylidynetrimethyl trimethacrylate is not classified according to the criteria of CLP Regulation(EC) N° (1272-2008).
- Executive summary:
Propylidynetrimethyl trimethacrylate was tested for acute dermal toxicity in wistar rats in a limit dose assay, according to OECD guideline 402 in compliance with GLP. Groups of rats (5/sex) were administered a single dermal dose of propylidynetrimethyl trimethacrylate at 2000 mg/kg bw on clipped skin using a semi-occlusive patch for 24 h. Examinations for mortality, clinical signs and body weight gain were performed during a 14-day observation period. All surviving animals were necropsied at the end of the observation period. No deaths and clinical signs occurred during the observation period. All rats gained weight over of the study period. Red foci on the thymus, red foci on the mandibular lymph nodes and pale kidneys were noted at necropsy in one male. Large mandibular lymph nodes and pelvic dilatation of the kidneys were noted in one female. No cutaneous reactions were recorded in any animal throughout the observation period. The acute dermal LD50 for males and females was greater than 2000 mg/kg bw. Under the test conditions, propylidynetrimethyl trimethacrylate is not classified according to the criteria of the CLP Regulation (EC) N° 1272-2008.
Reference
Table 2: individual body weights
Dose level (mg/kg) |
Animal number and sex |
Body weight (g) at: |
Increment (g) |
|||||
Day -1 |
Day 1 |
Day 4 |
Day 8 |
Day 15 |
Day 1 to 8 |
Day 8 to 15 |
||
2000 |
30M |
275 |
279 |
285 |
297 |
317 |
18 |
20 |
31M |
322 |
324 |
315 |
326 |
334 |
2 |
8 |
|
32M |
289 |
285 |
285 |
291 |
304 |
6 |
13 |
|
33M |
339 |
341 |
332 |
340 |
351 |
-1 |
11 |
|
34M |
339 |
344 |
343 |
354 |
371 |
10 |
17 |
|
2000 |
35F |
201 |
201 |
204 |
206 |
219 |
5 |
13 |
36F |
200 |
196 |
197 |
201 |
212 |
5 |
11 |
|
37F |
187 |
189 |
184 |
191 |
195 |
2 |
4 |
|
38F |
194 |
191 |
190 |
191 |
204 |
0 |
13 |
|
39F |
186 |
186 |
185 |
187 |
201 |
1 |
14 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The dermal acute study is considered to be reliable, and was performed according to the OECD guidelines.
Additional information
acute toxicity: oral (Covance 2010):
In an acute oral class method toxicity study performed in accordance with GLP and OECD guideline 423, 6 Sprague Dawley female rats were given a single oral dose of propylidynetrimethyl trimethacrylate at the limit test dose of 2000 mg/kg bw.
Clinical signs were recorded immediately post dose, at approximately 15 and 30 minutes post dose, hourly between 1 and 4 hours post dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Rats were weighed on Day 1 (day before dosing) and on Days 1, 4, 8 and 15.
No mortality, no clinical signs, no change in body weight and no abnormalities in macroscopic examination of main organs were observed except red foci on the thymus, a large mandibular lymph node and red foci on the mandibular lymph node in one animal.
The oral LD50 for propylidynetrimethyl trimethacrylate is higher than 2000 mg/kg bw in rats.
acute toxicity: inhalation:
According to the Regulation EC no.1907/2006 : "In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided".
Acute data are available by oral and dermal route on TMPTMA.
Moreover the test substance has low vapour pressure (about 0.00345 Pa at 20°C) and high boiling point (>160 °C), so the potential for the generation of inhalable forms is low and exposure to humans via the inhalatory route would only be via aerosols and would be quite limited.
Therefore no acute inhalation test needs to be performed.
acute toxicity: dermal (Covance 2010):
Propylidynetrimethyl trimethacrylate was tested for acute dermal toxicity in wistar rats in a limit dose assay, according to OECD guideline 402 in compliance with GLP. Groups of rats (5/sex) were administered a single dermal dose of propylidynetrimethyl trimethacrylate at 2000 mg/kg bw on clipped skin using a semi-occlusive patch for 24 h. Examinations for mortality, clinical signs and body weight gain were performed during a 14-day observation period. All surviving animals were necropsied at the end of the observation period. No deaths and clinical signs occurred during the observation period. All rats gained weight over of the study period. Red foci on the thymus, red foci on the mandibular lymph nodes and pale kidneys were noted at necropsy in one male. Large mandibular lymph nodes and pelvic dilatation of the kidneys were noted in one female. No cutaneous reactions were recorded in any animal throughout the observation period. The acute dermal LD50 for males and females was greater than 2000 mg/kg bw.
acute toxicity: ip (Bio/dynamics 1982):
The purpose of this study was to evaluate the acute toxicity of the test material when administered by intraperitoneal injection to rats ; to determine the intraperitoneal LD50 of the material; and to determine whether neurologic effects could be produced with acute administration.
Five male five female rats were given a single oral dose of propylidynetrimethyl trimethacrylate at the dose of 2000, 3500, 5000 and 8000 mg/kg bw.
No animal died at 2000 mg/kg, however 4 males died at 3500 mg/kg, 4 males and 5 females at 5000 mg/kg, and 5 males and 4 females at 8000 mg/kg. Animals at all dose levels exhibited a number of neurologic abnormalities. Signs seen in animals which survived as well as those which included tremors, convulsions, ataxia, apparent hallucinations, head-searching behavior, alterations in limb and body tone (flaccidity or rigidity)., pelvic elevation, and impaired pupillary, righting, visual placing, toe pinch and startle reflexes. Signs seen only in animals which died (generally in single animals) included circling, pranding, spasticity, compulsive biting and impaired corneal reflex. Soft stool and fecal staining occurred in both corn oil and test material-treated animals and was, not considered related to test material administration. Signs seen in several test material treated animals during the post-dose period included decreased activity, hyperpnea, food consumption decrease, unthrifty coat and a number of other abnormalities. Animals which died and those which were killed after 14 days exhibited a large number of postmortem abnormalities, most notably in the abdominal viscera. Most of these appeared to represent irritation and/or infectious sequelae resulting from intraperitoneal injection of the vehicle and/or test material.
To conclude, the ip LD50 for propylidynetrimethyl trimethacrylate is 3900 mg/kg bw in male and female rats.
Justification for classification or non-classification
As oral and dermal LD50 are higher than 2000 mg/kg bw in rats, propylidynetrimethyl trimethacrylate is not classified in acute toxicity according to the CLP Regulation (EC) N°1272/2008.
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