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EC number: 435-790-1 | CAS number: 297730-93-9
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 November 2009 to 15 February 2010
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- yes
- Remarks:
- a very minor deviation in clinical observation reporting was occurred which did not effect study interpretation
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 435-790-1
- EC Name:
- -
- Cas Number:
- 297730-93-9
- Molecular formula:
- C9H5F15O
- IUPAC Name:
- 3-ethoxy-1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2-(trifluoromethyl)hexane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Margate, Kent, UK
- Age at study initiation: 7 weeks
- Weight at study initiation: 169-187 g for males and 143-160 g on receipt from supplier. Testing commenced two weeks later
- Fasting period before study: No
- Housing:
- Use of restrainers for preventing ingestion (if dermal): yes/no
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 13 days prior to treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2 deg C. (17-23 measured)
- Humidity (%): 55+/- 15% (35-62% measured)
- Air changes (per hr): 15+
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
IN-LIFE DATES: From: To: November 2009 to January 18, 2010
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 20% D-alpha-Tocopherol polyethylene glycol succinate (TPGS, Vitamin E) in water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency):
- Mixing appropriate amounts with (Type of food):
- Storage temperature of food:
VEHICLE
- Justification for use and choice of vehicle (if other than water):
Selected vehicle was used to assure proper reproducible dosing of vehicle.
- Concentration in vehicle:
- Amount of vehicle (if gavage): 3mL per kg of body weight
- Lot/batch no. (if required):
- Purity:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:
- Method of holding animals in test chamber:
- Source and rate of air:
- Method of conditioning air:
- System of generating particulates/aerosols:
- Temperature, humidity, pressure in air chamber:
- Air flow rate:
- Air change rate:
- Method of particle size determination:
- Treatment of exhaust air:
TEST ATMOSPHERE
- Brief description of analytical method used:
- Samples taken from breathing zone: yes/no
VEHICLE (if applicable)
- Justification for use and choice of vehicle:
- Composition of vehicle:
- Type and concentration of dispersant aid (if powder):
- Concentration of test material in vehicle:
- Lot/batch no. of vehicle (if required):
- Purity of vehicle:
TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used:
- Time intervals for shavings or clipplings:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution): 333mg/mL, 66.7 mg/mL, 13.3 mg/mL
- Constant volume or concentration used: Constant concentrations
- For solids, paste formed: yes/no
VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
USE OF RESTRAINERS FOR PREVENTING INGESTION: yes/no - Details on mating procedure:
- - M/F ratio per cage: one-to-one
- Length of cohabitation: Until mated ir until 14 days
- Proof of pregnancy:
From results of evaluation of vaginal lavage
- Further matings after two unsuccessful attempts: [no / yes (explain)] n.a. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The formulations were prepared at convenient intervals and were used within the 8 days stability period (established in Charles River Study No. 425881) at 2-8°C in the dark. The test item was formulated by adding the appropriate volume of vehicle (20% TPGS) to required amounts of test item and mixed manually and magnetically stirred until a visibly homogeneous suspension was obtained.
- Duration of treatment / exposure:
- 4-weeks for males starting 2 weeks prior to mating.
The females were dosed once daily from 2 weeks prior to mating then continued until at least Day 4 of lactation; the females were sacrificed with their litters between Days 5 and Day 7 of lactation. - Frequency of treatment:
- daily
- Details on study schedule:
- - Age at mating of the mated animals in the study: [...10 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 40, 200, 1000 mg/kg/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Based upon toxicity data from earlier studies.
- Positive control:
- None
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes / No / No data
Yes
- Time schedule: Daily
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT:
Yes
- Time schedule for examinations: Daily
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / No data
Yes - Sperm parameters (parental animals):
- Parameters examined in [all/P/F1/F2] male parental generations:
[testis weight, epididymis weight, daily sperm production, sperm count in testes, sperm count in epididymides, enumeration of cauda epididymal sperm reserve, sperm motility, sperm morphology, other:]
Sperm examined in the lavaged samples - Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: Yes
- If yes, maximum of [...] pups/litter ([...]/sex/litter as nearly as possible); excess pups were killed and discarded.
PARAMETERS EXAMINED
The following parameters were examined in [F1 / F2 / F3] offspring:
[number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities, other:]
GROSS EXAMINATION OF DEAD PUPS:
[no / yes, for external and internal abnormalities; possible cause of death was/was not determined for pups born or found dead.] - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals
- Maternal animals: All surviving animals
GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]
HISTOPATHOLOGY / ORGAN WEIGHTS
Histological examination was conducted on Control and High dose adult animals only. A section of each ovary and each epididymis, and a transverse section from each testis were stained with Haematoxylin and Eosin (H&E) and a further section from each testis was stained with PAS-Haematoxylin.
The following organs were examined:
Ovaries
Uterus, cervix and vagina
Testes (weighed individually)
Epididymides (weighed individually)
Seminal vesicles and coagulating gland,
Prostate gland
Pituitary gland - Postmortem examinations (offspring):
- SACRIFICE
Offspring killed or found dead were sexed, then checked for the presence of milk in the stomach and the presence of externally visible abnormalities. Any abnormal pups were preserved in 10% formalin or methylated ethyl alcohol as appropriate for possible future examination. Externally normal decedents were discarded. - Reproductive indices:
- Fertility index (male and female), gestation index
- Offspring viability indices:
- Birth index, live birth index, viability index
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no clinical observations that were considered to be related to treatment with the test article.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- At 0 mg/kg/day, one female (Animal 45) was killed prematurely on Day 23 of study following a dosing error. This animal swallowed part of the gavage during the dosing procedure; at necropsy part of the gavage tube was found in the oesophagus.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
There were no clinical observations or necropsy findings that were considered to be related to treatment with the test article.
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
Group mean body weight gain in treated males was similar to Control. No significantchanges were identified in the treated group mean values compared to Control. For females prior to mating, at 1000 mg/kg/day, group mean body weight gain over Week 0-2
was higher compared to Control, attaining statistical significance. However, this significance was achieved due to a low body weight gain for Control animals 42 and 43 over the first week
of treatment. Excluding these Control animals, group mean body weight gain was essentially similar to Control. Group mean body weight gains during gestation and lactation were similar
to Control.
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS)
There were no obvious effects of treatment on mating performance, fertility or duration of gestation.
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
There were no obvious effects of treatment on mating performance, fertility or duration of gestation.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
There were no obvious effects of treatment on mating performance, fertility or duration of
gestation.
ORGAN WEIGHTS (PARENTAL ANIMALS)
The weights of the male reproductive organs were essentially similar in all groups.
GROSS PATHOLOGY (PARENTAL ANIMALS)
HISTOPATHOLOGY (PARENTAL ANIMALS)
There were no histology findings following examination of the ovaries from the females or the epididymides and testes of the males that were considered to be related to treatment with the test article.
Effect levels (P0)
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Remarks on result:
- other: Generation: Parental and offspring (migrated information)
Results: P1 (second parental generation)
Effect levels (P1)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- ca. 1 000 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- organ weights and organ / body weight ratios
- histopathology: non-neoplastic
- reproductive performance
- other: Mating performance, fertility, duration of gestation and litter size were not impacted by treatment with the test article at dose levels up to 1000 mg/kg/day. The NOEL is 1000 mg/kg/day.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Details on results (F1)
There were no obvious effects of treatment on litter size, implant count or survival.
CLINICAL SIGNS (OFFSPRING) No adverse effects
BODY WEIGHT (OFFSPRING)
Mean litter and pups weights were essentially similar in all groups.
SEXUAL MATURATION (OFFSPRING)
ORGAN WEIGHTS (OFFSPRING)
GROSS PATHOLOGY (OFFSPRING)
HISTOPATHOLOGY (OFFSPRING)
OTHER FINDINGS (OFFSPRING): None
Effect levels (F1)
- Key result
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- ca. 1 000 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- viability
- body weight and weight gain
- gross pathology
- other: VIABILITY: There were no obvious effects of treatment on litter size, implant count or survival. CLINICAL SIGNS: No adverse effects BODY WEIGHT: Mean litter and pups weights were essentially similar in all groups. The NOEL is 1000 mg/kg/day.
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The no observed effect level (NOEL) for both parental and reproductive effects was 1000 mg/kg/day.
- Executive summary:
At levels up to 1000 mg/kg/day of MTDID 7910, there were no obvious effects of treatment on clinical observations, necropsy findings, body weight gain or food consumption. Mating performance, fertility, duration of gestation, litter size and survival, and litter and pup weights did not indicate any obvious adverse effect of treatment at any of the dose levels tested. Under the conditions of this study, the no observed effect level (NOEL) for both parental and reproductive effects was 1000 mg/kg/day.
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