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EC number: 700-678-4 | CAS number: 1076-12-6
- 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
Acute oral toxicity: 3/3 rats died at 2000 mg/kg bodyweight with 2/6 deaths seen at 300 mg/kg bodyweight.
The LD50 cut off value of TCD was estimated to be 500 mg/kg under the
conditions of this study.
Acute inhaled toxicity: Study was waived.
Acute dermal toxicity: no deaths seen in rats exposed at 2000 mg/kg
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:
- 18 September 2009 to 29 October 2009
- 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:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan Inc.
- Age at study initiation: 9 weeks
- Weight at study initiation: Experiment 1 = 195-205g; Experiment 2 = 185-189g
- Fasting period before study: 16-17 hours
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24
- Humidity (%): 55
- Air changes (per hr): 10-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 18 September to 02 October 2009 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/L and 200 mg/L
- Amount of vehicle (if gavage): 10 mL/kg bodyweight
- Lot/batch no. (if required): V8A6289
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bodyweight
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: guideline recommendations - Doses:
- 300 mg/kg bodyweight in Experiments 1 and 2; 2000 mg/kg in Experiment 3
- No. of animals per sex per dose:
- 3 per sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (or other)
- Frequency of observations and weighing: observations before dosing, at 30 minutes and 1, 2, 3 and 4 hours on day of administration and daily from days 2 to 15. Bodyeight determinaiton on day of dosing and on days 1, 3, 7 and 14 days thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: all organs and tissues examined macroscopically - Statistics:
- Mean and standard deviations of bodyweights calculated; no conducted statistical analysis
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Experiment 1: 1/3 animals died on day 3
Experiment 2: 1/3 animals died on day 2
Experiment 3: 3/3 animals died between 1 to 4 hours after dosing - Clinical signs:
- other: Mucous stools in 2/3 and 3/3 animals in experiments 1 and 2 respectively at 1 to 3 hours after dosing or on the following day of administration. Mucous stools 2/3 animals in experiment 3 at 1 and 2 hours after dosing. Soiled periproctal region in 1/3 and
- Gross pathology:
- No abnormalities observed at necropsy including the dead animals.
- Other findings:
- Death was considered to be caused by actions on the central nerve system or emaciation due to deterioration of general conditions.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 cut off value of TCD was estimated to be 500 mg/kg under the conditions of this study.
Reference
In surviving animals in experiments 1 and 2, mucous stool or soiled periproctal region all disappeared by 2 days after administration. Although the decreased body weight or suppressed body weight gain was noted on the following day of administration, favorable increased gain was observed on 3 days after administration or later in experiments 1 and 2.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 500 mg/kg bw
- Quality of whole database:
- Klimisch 1
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
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:
- 28 March 2013 to 16 April 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF, 12 Nousan No 8147, 2000
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate from MHRA included in reports
- Test type:
- fixed dose procedure
- Species:
- rat
- Strain:
- other: CD (Hsd SD) albino rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 278-316 g for males and 181-198g for females
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 50 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 deg C
- Humidity (%): 40-70 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs
IN-LIFE DATES: From: 02 April 2013 To: 16 April 2013 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 50mm x 50mm
- % coverage: 10
- Type of wrap if used: porous gauze held in place with a non-irritating de=ressing and further covered with a waterproof dressing encircled around the trunk of the animal
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with weak detergent in warm water.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight
- For solids, paste formed: /no - Duration of exposure:
- 24 Hours
- Doses:
- 2000 mg.kg bodyweight
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: frequent observations on day of dosing and twice per day until the end of the experimental period. Bodyweight recorded on Days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, other: macroscopic pathology - Statistics:
- mean body wieghts andweekly individual bodyweight changes recorded. No statistical analysis.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths during study
- Clinical signs:
- other: Slight to well-defined erythema was seen in two males (P1, P5) with very slight erythema noted in a further two males (P3, P4) and four females (P6, P8, P9, P10). These reactions had resolved by Day 6 for the males and Day 11 for the females. No dermal re
- Gross pathology:
- No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
- Other findings:
- The acute median lethal dermal dose (LD50) to rats of TCD was demonstrated to be greater than 2000 mg/kg bodyweight.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute median lethal dermal dose (LD50) to rats of TCD was demonstrated to be greater than 2000 mg/kg bodyweight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch 1
Additional information
Justification for classification or non-classification
The LC50 value was calculated at 500mg/kg, according to the CLP criteria this value falls under Acute Oral toxicity Category 4 -Harmful if swallowed.
For the dermal study the LC50 value was >2000mg.kg therefore TCD does not meet criteria for classification according to CLP for dermal toxicity.
The is not inhalation data available therefore classification is not possible for inhalation toxicity.
Overall the substance is classified as Acute Oral toxicity Category 4 -Harmful if swallowed.
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