Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
In both GPMT study conducted in compliance with OECD guideline 406 with TMPTMA, no animals showed any sign of skin reaction after challenge. Based on these data, TMPTMA is considered to be not skin sensitizing.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 29 to June 15, 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no certificate of analysis, no data on animal gender and purity of test substance
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea-pigs study was performed before the REACH regulation.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 312-490 g
- Housing: Housed singly or in pairs in solid-floor polypropylene cages
- Diet (e.g. ad libitum): Guinea Pig FD1 Diet (Special Diets Services Limited, Witham, UK), ad libitum
- Water (e.g. ad libitum): Mains tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 °C
- Humidity (%): 45-68%
- Air changes (per hour): 15/hour
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours light - Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- Range finding test:
- Intradermal induction exposure: 1, 5, 10 or 25% w/v in arachis oil
- Topical induction exposure: 25, 50, 75 or 100% w/v in arachis oil
- Topical challenge exposure: 25, 50, 75 or 100% w/v in arachis oil
Main test:
- Intradermal induction exposure: 25% w/v in arachis oil
- Topical induction exposure: Undiluted
- Topical challenge exposure: 75 or 100% w/v in arachis oil - Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Range finding test:
- Intradermal induction exposure: 1, 5, 10 or 25% w/v in arachis oil
- Topical induction exposure: 25, 50, 75 or 100% w/v in arachis oil
- Topical challenge exposure: 25, 50, 75 or 100% w/v in arachis oil
Main test:
- Intradermal induction exposure: 25% w/v in arachis oil
- Topical induction exposure: Undiluted
- Topical challenge exposure: 75 or 100% w/v in arachis oil - No. of animals per dose:
- Range finding test:
- Intradermal induction exposure: 1 animal/dose
- Topical induction and challenge exposure: 2 animals/dose
Main test: 10 and 20 animals for control and test, respectively - Details on study design:
- RANGE FINDING TESTS:
- Intradermal induction exposure: Guinea pigs (1/dose) received injections (0.1 mL) of test material at concentrations of 1, 5, 10 or 25% w/v in arachis oil and observed for systemic toxicity and erythema scores (Draize scoring system) at 24, 48 and 72 hours and 7 days.
- Topical induction exposure: Two guinea pigs [intradermally injected with Freund's Complete Adjuvant (FCA) 16 days earlier] applied with test material at concentrations of 25, 50, 75 or 100% v/v in arachis oil for 48 hours and observed for erythema and oedema at 1, 24 and 48 hours.
- Topical challenge exposure: Two guinea pigs applied with test material at concentrations of 25, 50, 75 or 100% v/v in arachis oil for 24 hours and observed for erythema and oedema at 1, 24 and 48 hours.
MAIN STUDY
A. INDUCTION EXPOSURE: INTRADERMAL
- No. of exposures: One
- Test groups: Intradermally injected with 0.1 mL of FCA, 25% w/v test material in arachis oil and 25% w/v test material emulsion in FCA on Day 0
- Control group: Intradermally injected with FCA, arachis oil or 50% w/v arachis oil in FCA on Day 0
- Site: Shoulder region on each side of mid-line
- Duration: Days 0-6
B. INDUCTION EXPOSURE: TOPICAL
- No. of exposures: One
- Exposure period: 48 hours
- Test groups: Filter paper patch saturated with undiluted test material topically applied on Day 7 via occlusive patch
- Control group: Only filter paper patch topically applied on Day 7 via occlusive patch
- Site: Shoulder region on each side of mid-line
- Frequency of applications: Single application
- Duration: Days 7-21
C. CHALLENGE EXPOSURE: TOPICAL
- No. of exposures: One
- Day of challenge: Day 21
- Exposure period: 24 hours
- Test groups: Filter paper patch saturated with 75 or 100% v/v test material in arachis oil topically applied on Day 21 via occlusive patch
- Site: 75 or 100% v/v in arachis oil was applied to left or right shorn flank, respectively
- Evaluation (hour after removal of challenge patch): 24 or 48 hours - Challenge controls:
- No data
- Positive control substance(s):
- yes
- Remarks:
- Historical data: Ethyl 4-aminobenzoate 98%; 2,4-Dinitrochlorobenzene; Neomycin sulphate; 2-Mercaptobenzothiazole
- Positive control results:
- Historical data (August 1994 to February 1996):
- Incidence of sensitisation for 98% ethyl 4-aminobenzoate, 2,4-dinitrochlorobenzene, neomycin sulphate, 2-mercaptobenzothiazole were 39% (7/18), 100% (9/9), 100% (10/10), 60% (12/20) or 70% (7/10), respectively - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 or 100% v/v in arachis oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75 or 100% v/v on arachis oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- (2-mercaptobenzothiazole)
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not skin sensitizing
- Conclusions:
- Under these test conditions, TMPTMA is not a skin sensitiser and is not classified according to the CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD guideline 406 and in compliance with GLP, groups of 20 albino Dunkin Hartley guinea pigs were intradermally induced with three injections of 0.1 mL of FCA, 25% w/v TMPTMA in arachis oil and 25% w/v TMPTMA emulsion in FCA on Day 0 on shoulder region on each side of mid-line. After one week the same area were topically induced with 0.2 mL of undiluted test material via occluded filter paper patch for 48 hours. After 2 weeks of rest period, a challenge patch of 75 or 100% v/v test material in arachis oil was applied to left or right shorn flank, respectively. Control groups of 10 animals was included and treated with FCA, arachis oil or 50% w/v arachis oil in FCA. The test concentrations for the main study were determined from a sighting study using two animals.
Intradermal and topical induction indicated evidence of dermal irritation. No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-hour observations. TMPTMA produced a 0% (0/20) sensitisation rate and was considered to be a nonsensitiser to guinea pig skin. Historical data on positive controls (ethyl 4-aminobenzoate 98%; 2,4-dinitrochlorobenzene; neomycin sulphate; 2-mercaptobenzothiazole) exhibited evidence of sensitisation, thus confirming the susceptibility of this group of animals to dermal sensitisation.
Under these test conditions, TMPTMA is not classified according to the Annex VI to the CLP Regulation (EC) N° 1272-2008.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- April/May 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea-pigs study was performed before the REACH regulation.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Shamrock Bio Service (France)
- Age at study initiation: no data
- Weight at study initiation: males = 336+/-14 g, females = 328+/-8 g
- Housing: individually housed in sterilizable polycarbonate cages
- Diet (e.g. ad libitum): Certified pellet diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 50+/-20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- A preliminary test allowed to define the dose of the test substance to be administered in the main study. The sensitization of the animals by intradermal route was performed with the test substance at the concentration of 10% in the vehicle which is a non-irritant dose.
The sensitization of the animals by cutaneous route and challenge was made with the test substance in its original form, which is the aximum non-irritant dose, and was covered by an occlusive dressing for 24 hours. - Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- A preliminary test allowed to define the dose of the test substance to be administered in the main study. The sensitization of the animals by intradermal route was performed with the test substance at the concentration of 10% in the vehicle which is a non-irritant dose.
The sensitization of the animals by cutaneous route and challenge was made with the test substance in its original form, which is the aximum non-irritant dose, and was covered by an occlusive dressing for 24 hours. - No. of animals per dose:
- Control group : 5 males and 5 females
Treated group: 10 males and 10 females - Details on study design:
- During a 10-day sensitisation period (D1 to D11), the test substance was administered by intradermal injection (D1) and by cutaneous application (D9). The intradermal administrations of the test substance and vehicle were performed in the presence of an adjuvant in order tp maximize any potential cutaneous sensitization reactions. After a 15-day rest period, another cutaneous application of the test substance was performed (Day 26) in order to induce any potential cutaneous sensitization reactions.
In all animals, the application site was clipped just before each treatment, on day 1 and day 8 on the scapular area (4x2 cm) and clipped again and shaved on day 25 on each flank (2x2 cm).
The animals were observed daily in order to record any eventual clinical signs, which appeared during the study and to check for mortality.
On day 29, the animals were weighed and then sacrified after CO2 inhalation in excess after the 48-hour scoring period. Cutaneous samples were taken from the challenge application site of each animal and were preserved in 10% buffered formalin.
No histological examinations were performed. - Challenge controls:
- no
- Positive control substance(s):
- no
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under these experimental conditions and according to the maximalisation method of Magnusson and Kligman, no cutaneous reactions likely to have been caused by the sensitization potential of the test substance TMPTMA were observed in the Guinea-pigs.
- Executive summary:
The sensitization potential of the test substance TMPTMA was evaluated in the Guinea-pig by intradermal injection and cutaneous application. The evaluation was performed after a 10 -day induction period, during the animals treated with the vehicle (control group, 5 males and 5 females) or the test substance (treated group, 10 males and 10 females). On day 1, in the presence of Freund's adjuvant, 0.1 ml of the test substance was administered by intradermal route at a concentration of 10% in paraffin oil. On Day 9, 0.5 ml of the test susbtance in its original form was applied by cutaneous route. After a period of 15 days without treatment, a challenge cutaneous application of 0.5 ml of the vehicle (left flank) was then administered to all animals. The substances were held in place for 24 hours by means of an occlusive dressing. The cutaneous reactions were then evaluated at the challenge application site, 24 and 48 hours after removal of the dressing. After the final scoring period, the animals were sacrified and cutaneous samples were taken from the challenge appplication sites in all animals. Due to the absence of any "doubtful" macroscopic cutaneous reactions, no histological examination was performed on the cutaneous samples.
No symptoms were observed throughout the study. After the challenge application of the vehicle or the test substance, no cutaneous reactions were observed in the animals from the control and the treated groups.
Under these experimental conditions and according to the maximalisation method of Magnusson and Kligman, no cutaneous reactions likely to have been caused by the sensitization potential of the test substance TMPTMA were observed in the Guinea-pigs.
Referenceopen allclose all
Table 1: Intradermal sighting test - summary of results
Animal identification |
Time of observation |
Concentration of test material (% w/v) |
Grade of erythema at Injection Sites |
Evidence of systemic toxicity |
A |
24 hours |
1 |
1 |
None |
48 hours |
2 |
None |
||
72 hours |
3 |
None |
||
7 days |
0 |
None |
||
B |
24 hours |
5 |
1 |
None |
48 hours |
2 |
None |
||
72 hours |
3 |
None |
||
7 days |
0 |
None |
||
E |
24 hours |
10 |
1 |
None |
48 hours |
1 |
None |
||
72 hours |
1 |
None |
||
7 days |
1 |
None |
||
F |
24 hours |
25 |
2 |
None |
48 hours |
2 |
None |
||
72 hours |
2 |
None |
||
7 days |
1 |
None |
Conclusion: The concentration of the test material selected for the intradermal induction stage of the main study was 25% w/v in arachis oil BP
Table 2: Topical sighting test for induction application (48-hour exposure) - individual skin reactions
Animal identification |
Concentration of test material (% v/v) |
Skin Reactions (Hours After Removal of Patches) |
||||||||
1 |
24 |
48 |
||||||||
Er |
Oe |
Other |
Er |
Oe |
Other |
Er |
Oe |
Other |
||
G |
100 |
2 |
1 |
- |
1 |
0 |
- |
0 |
0 |
- |
75 |
2 |
1 |
- |
1 |
0 |
- |
0 |
0 |
- |
|
50 |
2 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
25 |
1 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
H |
100 |
2 |
0 |
- |
2 |
0 |
- |
1 |
0 |
- |
75 |
2 |
0 |
- |
1 |
0 |
- |
0 |
0 |
- |
|
50 |
1 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
25 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
Conclusion: The undiluted test material was selected for the main study topical induction
Table 3: Topical sighting test for challenge application (24-hour exposure) - individual skin reactions
Animal identification |
Concentration of test material (% v/v) |
Skin Reactions (Hours After Removal of Patches) |
||||||||
1 |
24 |
48 |
||||||||
Er |
Oe |
Other |
Er |
Oe |
Other |
Er |
Oe |
Other |
||
I |
100 |
1 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
75 |
1 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
50 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
25 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
J |
100 |
1 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
75 |
1 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
50 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
25 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
Er = erythema; Oe = oedema; - = no other reactions noted
Conclusion: The concentrations of the test material selected for the main study topical challenge were 100 and 75% v/v in arachis oil BP
No special symptoms were observed throughout the study. No mortality occurred.
The bodyweight gain of the treated animals was normal when compared to that of the control animals.
On day 11, after removal of the dressing, a cutaneous irritation in the control animals and a slight necrosis in the treated animals were noted at the intradermal injection sites.
No cutaneous reactions were observed on the left flanks (vehicle) and right flanks (test substance) in all control and treated animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Key study (Safepharm, 1996):
In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD guideline 406 and in compliance with GLP, groups of 20 albino Dunkin Hartley guinea pigs were intradermally induced with three injections of 0.1 mL of FCA, 25% w/v TMPTMA in arachis oil and 25% w/v TMPTMA emulsion in FCA on Day 0 on shoulder region on each side of mid-line. After one week the same area were topically induced with 0.2 mL of undiluted test material via occluded filter paper patch for 48 hours. After 2 weeks of rest period, a challenge patch of 75 or 100% v/v test material in arachis oil was applied to left or right shorn flank, respectively. Control groups of 10 animals was included and treated with FCA, arachis oil or 50% w/v arachis oil in FCA. The test concentrations for the main study were determined from a sighting study using two animals.
Intradermal and topical induction indicated evidence of dermal irritation. No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-hour observations. TMPTMA produced a 0% (0/20) sensitisation rate and was considered to be a nonsensitiser to guinea pig skin. Historical data on positive controls (ethyl 4-aminobenzoate 98%; 2,4-dinitrochlorobenzene; neomycin sulphate; 2-mercaptobenzothiazole) exhibited evidence of sensitisation, thus confirming the susceptibility of this group of animals to dermal sensitisation.
Supporting study (CIT, 1989):
The sensitization potential of the test substance TMPTMA was evaluated in the Guinea-pig by intradermal injection and cutaneous application. The evaluation was performed after a 10 -day induction period, during the animals treated with the vehicle (control group, 5 males and 5 females) or the test substance (treated group, 10 males and 10 females). On day 1, in the presence of Freund's adjuvant, 0.1 ml of the test substance was administered by intradermal route at a concentration of 10% in paraffin oil. On Day 9, 0.5 ml of the test susbtance in its original form was applied by cutaneous route. After a period of 15 days without treatment, a challenge cutaneous application of 0.5 ml of the vehicle (left flank) was then administered to all animals. The substances were held in place for 24 hours by means of an occlusive dressing. The cutaneous reactions were then evaluated at the challenge application site, 24 and 48 hours after removal of the dressing. After the final scoring period, the animals were sacrified and cutaneous samples were taken from the challenge appplication sites in all animals. Due to the absence of any "doubtful" macroscopic cutaneous reactions, no histological examination was performed on the cutaneous samples.
No symptoms were observed throughout the study. After the challenge application of the vehicle or the test substance, no cutaneous reactions were observed in the animals from the control and the treated groups.
Under these experimental conditions and according to the maximalisation method of Magnusson and Kligman, no cutaneous reactions likely to have been caused by the sensitization potential of the test substance TMPTMA were observed in the Guinea-pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, no classification for skin sensitisation is required for TMPTMA according to the CLP Regulation (EC) N° 1272-2008.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)