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EC number: 225-060-7 | CAS number: 4635-87-4
- 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 oral NOAEL is 50 mg/kg bw/day.
Inhal NOAEL could not be determined (test not reliable).
Dermal NOAEL was not investigated.
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:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019-2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 2018
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Wistar Han
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Chemical analyses of formulations were conducted in Week 1, 6 and 13 to assess accuracy
and homogeneity. Analytical method: UPLC. - Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily, according to the most recent individual animal weights.
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 15 mg/kg bw/day (nominal)
- Remarks:
- Mean accuracy for formulation in Week 1 was just below the target concentration (i.e. 89% of target 90-110%), and therefore an adjustment of the preparation procedure was made from Week 3 onwards. This resulted in mean accuracies that were in agreement with target concentrations in Weeks 6 and 13 for Group 3. Test formulations prepared were considered homogeneous on all occasions.
- Dose / conc.:
- 5 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Observations and examinations performed and frequency:
- The following parameters and end points were evaluated in this study: clinical signs,
functional observation tests, body weights, food consumption, ophthalmology, clinical
pathology parameters (hematology, coagulation, clinical chemistry, and thyroid hormone),
gross necropsy findings, organ weights, and histopathologic examinations. - Sacrifice and pathology:
- clinical pathology parameters (hematology, coagulation, clinical chemistry, and thyroid hormone),
gross necropsy findings, organ weights, and histopathologic examinations - Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At 50 mg/kg/day, hunched posture and erected fur were noted in several females between
Days 11 and 93. Moreover, thin appearance and abdominal distension were observed in one
female (No. 74) from Day 11 onwards.
Salivation seen after dosing among all test item dosed animals in a dose-related increased
incidence was not considered toxicologically relevant, taking into account the nature and
minor severity of the effect and its time of occurrence (i.e. after dosing). This sign was
considered to be a physiological response related to taste of the test item and/or vehicle rather
than a sign of systemic toxicity.
No findings were noted during the arena observations in this study.
Any other clinical signs noted during the Dosing Period occurred within the range of
background findings to be expected for rats of this age and strain which are housed and
treated under the conditions in this study and did not show any apparent dose-related trend. At
the incidence observed, these were considered to be unrelated to treatment with the test item - Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- At 50 mg/kg/day, one female was killed in extremis on Day 32. After inspection, the cause of death was considered unrelated to the test item.
One male at 5 mg/kg/day was found dead on Day 74. Cause of death was unclear after inspection, but considered not to be related to the test item. - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weights and body weight gain of treated females and males at 5 and 15 mg/kg/day were
considered to have been unaffected by treatment with test item.
At 50 mg/kg/day, in males, body weights were slightly lower compared to controls from
Day 29 onwards and mean body weight was 8% lower than controls on Day 91. Overall
bodyweight gain for males and females was 88% of controls.
Any other statistically significant changes in body weight gain were considered to be
unrelated to treatment with test item since no trend was apparent regarding dose and duration
of treatment. - Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- No ophthalmology findings were noted that were considered to be related to treatment with
test item.
The nature and incidence of ophthalmology findings noted during the Pretreatment Period and
in Week 13 was similar among the groups, and occurred within the range considered normal
for rats of this age and strain. These findings were therefore considered to be unrelated to
treatment with the test item. - Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Haematological parameters of treated rats were considered not to have been affected by
treatment with test item at 5 and 15 mg/kg/day.
At 50 mg/kg/day, an increased reticulocyte count was observed in males (1.28x) compared to
controls. Moreover, a decreased red blood cell count was observed in females (0.95x)
compared to controls - Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- No toxicologically relevant changes were noted in clinical biochemistry parameters at 5 and
15 mg/kg/day.
At 50 mg/kg/day, increased total protein and albumin levels were observed in males (1.04 and
1.08x of controls, respectively).
Any other statistically significant changes in clinical biochemistry parameters were
considered to be unrelated to treatment with test item as these occurred in the absence of a
dose-related trend or as the opposite effect would be expected in case of organ toxicity. - Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- see Clinical Signs
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- There were test item-related alterations in liver weights in both males and females at
50 mg/kg/day. Liver weights (relative to bodyweight) were statistically significantly increased in males and females treated at 50 mg/kg/day compared to the control animals.
There were no other test item-related organ weight changes. - Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- There were no test item-related gross observations.
All the recorded macroscopic findings were within the range of background gross
observations encountered in rats of this age and strain. - Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Test item-related microscopic findings after treatment with 3-Pentenenitrile were noted in the
liver of males and females, in the spleen of males and in the adrenal gland of females.
In the liver, an increased incidence of centrilobular hepatocellular hypertrophy was observed
in males treated at 15 and 50 mg/kg/day (minimal) and in females treated at 50 mg/kg/day
(minimal).
In the spleen, an increased severity of hematopoiesis and pigment was observed in males
treated at 15 and 50 mg/kg/day.
The remainder of the recorded microscopic findings were within the range of background
pathology encountered in rats of this age and strain. There was no test item-related alteration
in the prevalence, severity, or histologic character of those incidental tissue alterations. - Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- THYROID HORMONES
Total thyroxine (T4) levels were statistically significantly decreased in males at 15 and 50
mg/kg/day (0.81x and 0.75x of controls, respectively).
T4 levels in males at 5 mg/kg/day and females at all dose levels were comparable to controls.
Serum levels of thyroid stimulating hormone (TSH) and Triiodothyronine (T3) were
considered unaffected by treatment with the test item up to 50 mg/kg/day. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
- ophthalmological examination
- organ weights and organ / body weight ratios
- urinalysis
- other: Thyroid hormone
- Key result
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 50 mg/kg bw/day (nominal)
- System:
- integumentary
- Organ:
- liver
- Conclusions:
- In conclusion, administration of 3-Pentenenitrile by once daily oral gavage was well tolerated
in rats at levels of 50 mg/kg/day. Non-adverse alterations were observed in the in liver of
males starting at 15 mg/kg/day and in females at 50 mg/kg (minimal hepatocellular
hypertrophy) and in spleen of males starting at 15 mg/kg/day (increased hematopoiesis and
pigment). Based on these results, the no-observed-adverse-effect level (NOAEL) was
considered to be 50 mg/kg/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 50 mg/kg bw/day
- Study duration:
- subchronic
- Experimental exposure time per week (hours/week):
- 168
- Species:
- rat
- Quality of whole database:
- Guideline study with no deviations
Additional information
Justification for classification or non-classification
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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