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EC number: 416-900-5 | CAS number: 79723-02-7 TMAP
- 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
Endpoint summary
Administrative data
Description of key information
Reliable studies for skin irritation and eye irritation are available, performed according to EC/ OECD guidelines and GLP principles. In both studies, test substance is only indicated by abbreviation; no information on test substance purity (both Klimisch 2). Studies performed with TMAP, which is the same test substance as TMHP (tetramethylammonium hydrogen phthalate). In the SNIF file of the test substance, summaries of two other studies are available. The data on eye irritation are used as supporting study (Klimisch 2). Due to lack of experimental data, the skin irritation study from the SNIF file was found to be not reliable (Klimisch 3). All available data are consistent: tetramethylammonium hydrogen phthalate does not show irritant effect on the skin, but is found to be irritant to the eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 1987-July 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles. Test substance only indicated by abbreviation; no information on test substance purity.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- no information on test substance purity
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: approximately twelve to sixteen weeks old
- Weight at study initiation: 2.70 - 2.88 kg
- Housing: individually in suspended metal cages.
- Diet: ad libitum (Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.)
- Water: Free access to mains drinking water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 65 - 68
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 18 June 1987 To: 21 June 1987 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: moistened with water
- Controls:
- not required
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patch, secured with a strip of surgical adhesive tape (BLENDERM); the trunk of each rabbit was wrapped in an elasticated corset
(TUBIGRIP)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to Draize - Irritation parameter:
- erythema score
- Basis:
- animal: #1,2,3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean score; one animal scored 1 at 1h after exposure
- Irritation parameter:
- edema score
- Basis:
- animal: #1,2,3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean score
- Irritant / corrosive response data:
- Very slight erythema was noted at one treated skin site one hour after removal of the patches. No adverse skin reactions were noted at the remaining treated skin sites at this time or at any treated skin site at subsequent 24, 48 and 72- hour observations.
- Other effects:
- No corrosive effects were noted.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a skin irritation test in rabbits performed according to OECD guideline 404 and GLP principles, TMAP was found to be not irritating to rabbit skin.
- Executive summary:
A skin irritation test in rabbits was performed according to OECD guideline 404. Very slight erythema was noted at one treated skin site one hour after removal of the patches. No adverse skin reactions were noted at the remaining treated skin sites at this time or at any treated skin site at subsequent 24, 48 and 72- hour observations.
The test material produced a primary irritation index of 0.0 and was classified as non- irritant to rabbit skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles. No information on test substance purity.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no information on purity
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no information on purity
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: approximately 12 to 16 weeks old
- Weight at study initiation: 2.22 - 2.54 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum (RABMA Rabbit diet, Special Diet Services Ltd., Witham, Essex, U.K.)
- Water: free access to mains drinking water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 56-67
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 11 August 1993 To: 25 August 1993 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Reversibility of any observed effect: changes fully reversible within 14 days.
- Other effects:
- Other ocular effecs noted were a dulling of the normal lustre of the corneal surface (2 animals, 1 hour after treatment), sloughing of the cornea (in one eye at the 24 hour observation) and petechial haemorrhage of the conjunctival or nictitating membranes (in one eye at the 24, 48 and 72 hour observations).
- Interpretation of results:
- other: cat. 2
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on an eye irritation test with TMAP according to OECD/EC guidelines and GLP principles, the test substance is found to be irritating to the eyes (classified cat 2).
- Executive summary:
An eye irritation test with TMAP was performed according to OECD/ EC guidelines and GLP principles. The mean corneal opacity score at 24, 48 and 72 hours of three rabbits was found to be 1, 1 and 0. The mean iris score was <1 for all animals, mean conjunctival score was 2 for one rabbit and <2 for the other two. Mean chemosis score were <2 for all three rabbits. Other ocular effecs noted were a dulling of the normal lustre of the corneal surface (2 animals, 1 hour after treatment), sloughing of the cornea (in one eye at the 24 hour observation) and petechial haemorrhage of the conjunctival or nictitating membranes (in one eye at the 24, 48 and 72 hour observations). All effects were reversible within 14 days.
Since the corneal opacity was ≥ 1 in 2 of the three tested animals (mean 24, 48 and 72 hours), TMAP is regarded as irritant to the eye (classified cat 2).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A reliable skin irritation test in rabbits was performed according to OECD guideline 404. Very slight erythema was noted at one treated skin site one hour after removal of the patches. No adverse skin reactions were noted at the remaining treated skin sites at this time or at any treated skin site at subsequent 24, 48 and 72- hour observations.This result is confirmed in a non-reliable study.
An eye irritation test with TMAP was performed according to OECD/ EC guidelines and GLP principles. The mean corneal opacity score at 24, 48 and 72 hours of three rabbits was 1, 1 and 0. The mean iris score was <1 for all animals, mean conjunctival score was 2 for one rabbit and <2 for the other two. Mean chemosis score were <2 for all three rabbits. Other ocular effecs noted were a dulling of the normal lustre of the corneal surface (2 animals, 1 hour after treatment), sloughing of the cornea (in one eye at the 24 hour observation) and petechial haemorrhage of the conjunctival or nictitating membranes (in one eye at the 24, 48 and 72 hour observations). All effects were reversible within 14 days.
In the available SNIF file for tetramethylammonium hydrogen phthalate, an eye irritation test with TMAP is summarized, performed according to OECD/ EC guidelines and GLP principles. The mean corneal opacity score at 24, 48 and 72 hours of three rabbits was found to be 1, 1 and 0. The mean iris score was 0.5, 1 and 0, mean conjunctival score was 2 for two rabbits and 1 for the third. Mean chemosis scores were 1 for all three rabbits. Other ocular effects noted were a dulling of the normal lustre of the corneal surface, sloughing of the cornea and petechial haemorrhage of the conjunctival or nictitating membranes. All effects were reversible within 3 days.
It is of note that TMAP is the same test substance as TMHP (tetramethylammonium hydrogen phthalate).Justification for selection of skin irritation / corrosion endpoint:
One reliable study is available.
Justification for selection of eye irritation endpoint:
There are 2 reliable studies available, a key study and a supporting study. The key study has been selected. Based on the results of both studies, the substance needs to be classified.
Effects on eye irritation: irritating
Justification for classification or non-classification
As in two reliable studies the corneal opacity was ≥ 1 in two of the three tested animals (mean 24, 48 and 72 hours) and in addition in one of these 2 studies also the mean conjunctival score was ≥ 2 in two of the three tested animals (mean 24, 48 and 72 hours), TMHP needs to be classified as irritating to the eyes (category 2) according to Regulation (EC) No 1272/2008.
Based on the available skin irritation studies with tetramethylammonium hydrogen phthalate, the substance does not need to be classified as irritating to skin according to Regulation (EC) No 1272/2008.
Based on the available studies, the substance does not need to be classified according to the DSD for skin and eye irritation.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.