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EC number: 269-348-0 | CAS number: 68227-33-8
- 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
Mortality, physical observations, body weight, and food consumption data, as well as gross necropsy observations did not reveal any adverse effects considered to be attributable to the administration of TMDDD at any of the dose levels.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The standard and sample solutions were analysed by GC using the following conditions:
GC system : Agilent Technologies 5890, incorporating
autosampler and workstation
Column : DB-Wax (30 m x 0.32 mm id x 0.25 μm film)
Oven temperature program : initial 100 ºC for 0 mins
rate 20 ºC/min
final 250 ºC for 15 mins
Injection temperature : 200 ºC
Flame ionisation detector
temperature
: 250 ºC
Injection volume : 1 μl
Retention times : ~ 6.3 mins
~ 8.5 mins - Details on study design:
- Methods. The test material was administered by gavage to three groups, each of ten
male and ten female Wistar Han™:HsdRccHan™:WIST strain rats, for up to forty-five
consecutive days (including a two week maturation phase, pairing, gestation and early
lactation for females), at dose levels of 50, 100 and 200 mg/kg/day. Following the early
termination of one 200 mg/kg/day male and one female from this dose group being found
dead, the 200 mg/kg/day dose group was reduced to 125 mg/kg/day from Day 11
onwards. A control group of ten males and ten females was dosed with vehicle alone
(Polyethylene glycol 400). Two recovery groups, each of five males and five females,
were treated with the high dose (200 mg/kg/day reduced to 125 mg/kg/day from Day 11
onwards) or the vehicle alone for forty-two consecutive days and then maintained without
treatment for a further fourteen days.
Clinical signs, behavioural assessments, bodyweight change, and food and water
consumption were monitored during the study.
Pairing of animals within each dose group was undertaken on a one male: one female
basis within each treatment group on Day 15 of the study, with females subsequently
being allowed to litter and rear their offspring to Day 5 of lactation.
During the lactation phase, daily clinical observations were performed on all surviving
offspring, together with litter size and offspring weights and assessment of surface
righting reflex.
Extensive functional observations were performed on five selected males from each
dose group after the completion of the mating phase, and for five selected parental
females from each dose group on Day 4 post partum. Urinalysis was performed on five
non-recovery males per dose group during the final week of treatment and five nonrecovery
males and females from each dose group were selected for haematology and
blood chemistry assessments prior to termination.
Surviving males were terminated on Day 43, followed by the termination of all surviving
females and offspring on Day 5 post partum. All animals were subjected to a gross
necropsy examination and histopathological evaluation of selected tissues was
performed.
Following forty-two days of treatment, recovery group animals were maintained without
treatment for a further fourteen days. Urinalysis was performed on all surviving recovery
group males during the final week of the treatment period. In addition, haematological
and blood chemical assessments were performed on all surviving recovery group
animals at the end of the treatment-free period. These animals were then subjected to a
gross necropsy and histopathological examinations of selected tissues was performed. - Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no unscheduled deaths that were considered to be related to test material toxicity. The deaths seen at the high dose level, 100 and 50 mg/kg/day are considered to be due to the process of gavage administration of the test material, inducing severe pulmonary lesions, and not the related inherent toxicity of the test material. The clinical observations detected during this study were not considered to be related to systemic toxicity.
- Mortality:
- no mortality observed
- Description (incidence):
- There were no unscheduled deaths that were considered to be related to test material toxicity. The deaths seen at the high dose level, 100 and 50 mg/kg/day are considered to be due to the process of gavage administration of the test material, inducing severe pulmonary lesions, and not the related inherent toxicity of the test material. The clinical observations detected during this study were not considered to be related to systemic toxicity.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No adverse effect on bodyweight development or bodyweight gain was detected.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No adverse effect on food consumption or food efficiency was detected.
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- No adverse effect on food consumption or food efficiency was detected.
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Description (incidence and severity):
- No treatment-related intergroup differences in water intake were detected.
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- There was no adverse effect on the haematological parameters measured.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- There was no adverse effect on the blood chemical parameters measured.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related intergroup differences were detected in the urinalytical paramenters measured.
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- There were no adverse changes in the behavioural assessment measurements.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- An increase in liver and thyroid weights was evident in the non-recovery high dose males, in comp. to contr. No adv. eff. was evident in the non-recovery high dose females, animals or either sex treated with 100 or 50 mg or recovery high dose groups.
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Centrilobular hepatocellular hypertrophy was evident in the non-recovery high dose males only. No such effect was evident in the non-recovery high dose females, males treated with 100 or 50 mg/kg/day or recovery high dose males.
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Necropsy: No adverse abnormalities were detected for treated adults in comparison to
controls. No adverse macroscopic abnormalities were detected for offspring dying during lactation or at termination on Day 5 post partum. - Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOEL
- Effect level:
- 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No treatment-related effects were observed in females at the high dose level. Therefore, the "No Observed Effect Level" (NOEL) for systemic toxicity for females was considered to be 125 mg/kg/day.
- Critical effects observed:
- no
- Conclusions:
- The oral administration of Surfynol 124 to rats for a period of up to ten days at a dose level of 200 mg/kg/day resulted in three interim deaths. The clinical findings observed in these three animals suggested that their deaths may be attributed to the gavage administration of an irritant test material and not the inherent toxicity of the test material. Therefore, in order to prevent the likelihood of further adult mortalities the high dose level was reduced to 125 mg/kg/day from Day 11 onwards. In total the test material was administered for up to forty five consecutive days at dose levels of up to 125 mg/kg/day resulting in treatment-related effects at the high dose level. Increased organ eight measurements were identified in the liver and thyroid. Furthermore, liver changes were identified as centrilobular hepatocyte hypertrophy. These were considered to be adaptive and not to represent an adverse health effect and therefore the "No Observed Adverse Effect Level" (NOAEL) for systemic toxicity was considered to be 125 mg/kg/day for males only.
No treatment-related effects were observed in females at the high dose level. Therefore, the "No Observed Effect Level" (NOEL) for systemic toxicity for females was considered to be 125 mg/kg/day.
No treatment-related effects were detected in the reproductive parameters measured, therefore the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 125 mg/kg/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 125 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The key study is GLP compliant and is of high quality, Klimisch score = 1. It is done according to OECD guideline 422.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
In the absence of any evidence for species specific effects or modes of action the effects observed in animals are regarded as relevant for humans. However, according to latest scientific discussions the relevance of hepatic effects observed in rodents for humans is currently subject of intensive research.
Additional information
Mortality, physical observations, body weight, and food consumption data, as well as gross necropsy observations did not reveal any adverse effects considered to be attributable to the administration of TMDDD at any of the dose
levels. NOAEL = 125 mg/kg bw.
Justification for classification or non-classification
According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 no classification 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.
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