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EC number: 214-071-2 | CAS number: 1077-28-7
- 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:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-03-26 - 1998-05-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Study owner prepared study while seeking authorisation of the substance as active incredient for medical treatment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ICH S5, 4.1.2
- Version / remarks:
- ICH 4.1.2
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5-(dithiolan-3-yl)valeric acid
- EC Number:
- 214-071-2
- EC Name:
- 5-(dithiolan-3-yl)valeric acid
- Cas Number:
- 1077-28-7
- Molecular formula:
- C8H14O2S2
- IUPAC Name:
- 5-(1,2-dithiolan-3-yl)pentanoic acid
- Reference substance name:
- unknown
- IUPAC Name:
- unknown
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- dihydrogen oxide
- Test material form:
- solid: bulk
- Details on test material:
- This composition is the usual techical grade of AlzChem AG. It will be used when test substance has this composition (or is very closed) or no specific information is available
Constituent 1
impurity 1
impurity 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Adaption period: at least 6 days
Age: 7 weeks
B.w. (day 0 of gestation, day of conception): 189 - 236 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Remarks:
- 2.15 ml/kg b.w.
- Details on exposure:
- from implantation (6th day of gestation) until the end of lactation (dams of the F0-genaration only)
- Details on mating procedure:
- One male and one female of each group are raised to maturity and mated at the age of 13 weeks. Inbreeding was not carried out. Males were scrificed after the mating period
- Duration of treatment / exposure:
- from implantation until the end (22nd day) of lactation.
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Group 1: Control (2.15 ml/kg b.w. propylene glycol)
- Dose / conc.:
- 14.7 mg/kg bw/day (nominal)
- Remarks:
- Group 2: low dose
- Dose / conc.:
- 31.6 mg/kg bw/day (nominal)
- Remarks:
- Group 3: intermediate dose
- Dose / conc.:
- 68.1 mg/kg bw/day (nominal)
- Remarks:
- Group 4: high dose
- No. of animals per sex per dose:
- 96 females: 20 per group + 16 spare animals
- Control animals:
- yes
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- Clinical signs, viability, b.w., food consumption
- Litter observations:
- b.w., sex, number of live and dead pups
- Statistics:
- Bartlett chi-square test
Dunnett test (p <= 0.01)
Student's t-test (p <= 0.01) - Reproductive indices:
- gestation, index, birth index, Live birth index, viability index, lactation index, overall survival
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- one high dosed animal died on day 21 of gestation
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- decreased b.w. in high dosed females.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- -10 to -14 % (compared to control, not significent at p <= 0.01) in intermediate-dose group
-7 to -15 % (compared to control, significent at p <= 0.01) in high-dose group - Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- 1 stillbirth at low dosage (2 in control group)
Lactaion index marginally and significantly (at p <= 0.05) decreased at the high dose.
One of the pups from a high-dosed dam was malformed, it showed haematomas in the head region. This malformation was considered as spontaneous ans not substance-related.
Effect levels (P0)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- ca. 14.7 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- food consumption and compound intake
- reproductive performance
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Effect levels (P1)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- ca. 31.6 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
- Other effects:
- not examined
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- no effects observed
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Key result
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- ca. 31.6 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- not examined
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- no effects observed
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not examined
Effect levels (F2)
- Key result
- Dose descriptor:
- NOEL
- Generation:
- F2
- Effect level:
- ca. 68.1 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the Present test conditions the following no-effect dose levels were observed:
Effects in the F0-dams during gestation and lactation
NOEL: 14.7 mg/kg b.w./day p.o.
Effects on dewelopment of the conceptus and the offspring (F1-generation) trough sexual maturity
NOEL: 31.6 mg/kg b.w./day p.o.
F2-generation
NOEL: > 68.1 mg/kg b.w./day p.o
Hence, under the present test conditions, the marginally reduced lactation index occured an a dose level that also caused maternal toxicity, and hence, was related to it.
No effect was observed at doses below the maternal toxicity. - Executive summary:
F0 -dams
Mortlity:
None of the low- and intermediate-dosed female animals died prematurely.
One high-dosed female died prematurely on the 21st day of gestation following a rupture of the cardiac artrium. All circumstance connected with the exitus indicate that this death was spontaneous.
Clinical signs:
No substance-related effects were observed on behaviour, external appearance and faeces ind teh dams of the low and intermediate testes dose levels. 7 of 21 pregnant high-dosed animals showed a slightly reduced motility during the first 3 days of treatment.
Body weight:
No substance-related difference in b.w. between treated and control female animals was noted at the low- and intermediate-dose level.
The high dose caused a very marginal - though still detectable - decrease in b.w. during the gestation period (between 2 % and 4 % compared to the controls, significant at p <= 0.01 on gestation days 10, 13, 15, 16) and during the lactation period (between 7 % and 8 % compared to the controls, significant at p <= 0.01 on gestation days 7, 14).
Food consumption:
The relative food consumption was not influenced at the low dose level.
A mild transient decrease in the relative food consumption was noted in the intermediate dose between the 18th and 21st gestation day. The difference fron the controls was minus 10 % to minus 14 % (not significant at p <= 0.01).
A mild decrease in the relative food consumption was also noted at the high dose (on 10th and between 13th and 21st gestation day, minus 7 % to minus 15 %, significant at p <= 0.01 on the 13th, 14th and 19th gestation day).
Reproduction:
The low, intermediate and high dose did not influence the reproduction parameters of the rats. The duration of pregnancy was within the normal range, the parturition not inflienced.
Birth index, live birth index, viability index, lactation and overall survival index were similar to those of the control group at the low and the intermediate dose. However, the lactation index was marginally and significantly (at p <= 0.05) decreased at the high dose.
The number of pups born was not affecte, the pups developed normally. B.w. of pups at birth did not differ between the control and substance-treated groups.
1 stillbirth was observed at the low dose (control: 2 stillbirths). This finding is within the normal range of background data and was not attributed to the administration of the test compound.
One of the pups from a high dosed dam was malformed, it showed haematoms in the head region. This malformation was considered as spontaneous and not substance related.
Macroscopic post mortem findings:
Macroscopic inspection revealed no systemic changes connected with the treatment. the number of implants according to SALEWSKI was similar in the control and substance treated groups. A spontaneous rupture of the atrium was noted in the heart of 1 prematurely deceased high-dosed dam (the one where prematurely death was reported).
F1 -generation (until weaning)
Sex distribution: not influenced
B.w. during pre and post weaning: All values are within normal range at the low. intermediate and high dose.
External examination: Except for 1 malformation (see above) no abnormalities were observed.
Morphological landmarks, functional tests, open-field test:
The time-points for pinna detachment, upper incisor eruption, ear and eye opening, cleavage of the balanopreputilal gland and vagianl opening of the pups fren the low-, intermediate- and high-dosed dams were not influenced.
All functional tests and the open-field test revealed no subtance-related influence for the animals of low, the intermediate and the high dose.
Macroscopic post mortem findings: No substance related pathological changes were observed.
F1-dams and male F1-partners
Mortality: None of the rats died prematurely.
Clinical Signs: None of the F1-parent animals showed any changes of behaviour, external appearance and faeces.
B.w.: All values of the groups 2, 3, 4 were within the normal range
Reproduction:
All reproduction parameters were within the range of the controls. Duration of pregnancy and the parturition were not delayed. Birth index, live birth indedex, viability index, lactation and overall survival index were similar in all groups. No influence was noted on the number of pups born, their birth weight and their development.
One malformed pup in group 4 (a tailless pup) is considered as spontaneous.
Macroscopic post mortem findings: No changes were observed.
F2-generation (until weaning)
Sex distruibution: The sex distribution was not infuenced.
Body weight during pre- and post weaning: All values were within the normal range.
External examination: abnormalities were observed.
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