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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 253-138-0 | CAS number: 36631-30-8
- 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
The acute oral median lethal dose (LD50) of the test substance in rats (2 male and 2 female) was greater than 10 ml/kg bw (> 9590 mg/kg bw).
Under the conditions of the test, the read-across substance, tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, has an acute dermal LD50 in rabbits of > 2000 mg/kg bw).
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:
- 24 August 1983 to 7 September 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to acceptable standards.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The compound as supplied was administered as a single dose by gavage to 4 rats which had been fasted for 18 hours, at a rate of 10 ml/kg.
- GLP compliance:
- not specified
- Test type:
- other: Not specified
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Healthy Sprague Dawley RAI f (SPFTif) derived rats, bred on the premises, or imported from CIBA-GEIGY Limited, Basle, Switzerland,. aged 5-6 weeks, having an average body weight of 180 g (2 males) and 145 g (2 females).
Husbandry
Rats were caged singly and kept in a room maintained at a temperature of 21°C. (± 2°C). Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hour period. A commercial autoclavable pelleted diet (Labsure CRM rat and mouse) was fed ad lib. Filtered water was available at all times. - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The compound as supplied was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a rate of 10 ml/kg.
- Doses:
- 10 ml/kg
- No. of animals per sex per dose:
- 2 per sex per dose
- Control animals:
- no
- Details on study design:
- Observations
After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. - Statistics:
- None
- Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 9 590 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- None
- Body weight:
- No data
- Gross pathology:
- No abnormalities were seen throughout the 14 day observation period nor at terminal autopsy.
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the substance in rats was greater than 10 ml/kg bw (> 9590 mg/kg bw).
- Executive summary:
The acute oral median lethal dose (LD50) of the substance in rats (2 male and 2 female) was greater than 10 ml/kg bw (> 9590 mg/kg bw).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 9 590 mg/kg bw
- Quality of whole database:
- Study not conducted to GLP. Considered to be a Klimisch 2.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- exposure considerations
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- October 23 - November 04 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted according to recognised test methods
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Insecticide, fungicide & rodenticide Act part 163, Title 40; Code of the federal Regulations 40 CRF 163.81 & Principles & procedures for evaluating the toxicity of household substances Publication 1138, National Academy of Sciences-National Resear
- GLP compliance:
- yes
- Test type:
- other: Limit Test
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Becker Centalia Kansas USA
- Weight at study initiation: 2.3-3.2 Kg
IN-LIFE DATES: From: October 22 To: November 04 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back with longitudinal abrasions over the exposure area. Abrasions penetrated the stratum corneum but not deeply enough to cause bleeding
- % coverage: 10
- Type of wrap if used: gauze covered by rubber dam
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes area wiped
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 ml/kg
- Concentration (if solution): 100% (as supplied)
- Constant volume or concentration used: yes/no constant concentration
- For solids, paste formed: yes/no: N/A
VEHICLE: N/A
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of exposure:
- 24h
- Doses:
- 2.0 ml/kg
- No. of animals per sex per dose:
- 3 male & 3 females in TOTM group
2 males & 2 females in control group - Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Duration of observation period following administration: 14 days (or other?): 14d
- Frequency of observations and weighing: weighing on d 1, 7, 14
- Necropsy of survivors performed: yes/no: yes d15
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: - Statistics:
- No. N/A single dosage used.
- Preliminary study:
- No data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No confidence limits calculable as no mortality
- Mortality:
- None
- Clinical signs:
- No signs of toxicity seen during exposure & subsequent observation periods
- Body weight:
- No effects of exposure on body weight. All animals gained weight on days 7 & 14.
- Gross pathology:
- No observed abnormalities at necropsy.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test, the read-across substance, tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, has an acute dermal LD50 in rabbits of >2.0 ml/kg.
- Executive summary:
Under the conditions of this test, the read-across substance, tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, has an acute dermal LD50 in rabbits of >2.0 ml/kg bw
Reference
Mean (±SD) Body weights (g) of 3 male & 3 female rabbits exposed to 2.0 ml/kg TOTM and 2 male & 2 female control rabbits
Intervals |
Males |
Females |
||
|
Control1 |
TOTM 2.0 ml/kg |
Control1 |
TOTM 2.0 ml/kg |
|
|
|
|
|
Pre-exposure |
3.2 |
2.33 ± 0.06 |
2.8 ± 0.14 |
2.37 ± 0.06 |
Day 7 |
3.4 |
2. 30 ± 0.10 |
3.1± 0.07 |
2.53 ± 0.06 |
Day 14 |
3.6 |
2.46 ± 0.06 |
3.2 ± 0.14 |
2.67 ± 0.06 |
|
|
|
|
|
1Controls were untreated
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP compliant study conducted according to recognised test methods therefore categorised as Klimisch 1.
Additional information
The acute oral median lethal dose (LD50) of the test substance in rats (2 male and 2 female) was greater than 10 ml/kg bw (> 9590 mg/kg bw).
In an in vivo acute dermal toxicity study, the read-across substance, tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, has an acute dermal LD50 in rabbits of > 2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
Only 1 study is available.
Justification for selection of acute toxicity – inhalation endpoint
The test substance has a very low vapour pressure hence the potential for the generation of inhalable forms is low. Dermal exposure is considered to be the appropriate route of exposure and has been assessed accordingly. No acute inhalation test was performed.
Justification for selection of acute toxicity – dermal endpoint
Klmisch 1 study
Justification for classification or non-classification
The above studies have all been ranked reliability 1 or 2 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted according to recognised test methods. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for acute effects is therefore required.
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.