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EC number: 800-036-4 | CAS number: 1422423-64-0
- 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
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Justification for Read Across is detailed in the report attached to the IUCLID section 13.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- developmental toxicity
- Remarks:
- screening for reproductive / developmental toxicity
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Justification for Read Across is detailed in the report attached to the IUCLID section 13.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- OECD combined repeated dose and reproductive/developmental toxicity screening test
- Principles of method if other than guideline:
- combined repeated dose and reproductive/developmental toxicity screening test
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Route of administration:
- oral: gavage
- Details on mating procedure:
- 14 days
- Duration of treatment / exposure:
- Males: for 52 days
Females: from 14 days before mating to day 4 of lactation - Frequency of treatment:
- Daily
- Duration of test:
- Males: for 53 days
Females: from 43 to 47 days - Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- vehicle
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 12 animals/sex/dose
- Control animals:
- yes, concurrent vehicle
- Number of abortions:
- no effects observed
- Description (incidence and severity):
- There were no intergroup differences in the delivery index, implantation index, parturition index of neonates on day 4 of lactation.
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- There was no abnormality in the implantation sites, delivered offspring and live delivered offspring showed almost the same values.
- Changes in pregnancy duration:
- effects observed, treatment-related
- Description (incidence and severity):
- The gestation period was significantly shortened in the 100 and 1000 mg/kg groups compared with the control group. There was no abnormality in the conditions of parturition.
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: n.a.
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- other: gestation period
- Description (incidence and severity):
- low incidence and severity
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): effects observed, non-treatment-related
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): Body weight during lactation period was significantly low on days 0 and 4 of lactation in males and day 4 in females in the 100 mg/kg group and on day 4 in males in the 300 mg/kg group, which was the change not associated with the dose. - Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- There was no abnormality in the delivered offspring and live delivered offspring showed almost the same values.
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- There were no intergroup differences in the sex ratio and viability index of neonates on day 4 of lactation.
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In the external examination in neonates, anophthalmia and polydactyly were observed in 1 animal each in the 300 mg/kg group. These anomalies are considered to be spontaneous, because the incidences of these anomalies were extremely low and these are of types seen in historical control data.
- Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No abnormal findings considered to be attributable to administration of this compound were observed in dead pups during lactation and pups at scheduled sacrifice.
In the necropsy on day 4 of lactation, red patches on the plantar were observed in 15 males and 13 females in the 100 mg/kg group, and the number of occurrences significantly increased in both males and females compared with the control group. However, this finding occurred in litters in 2 broods in both males and females. In addition, dilation of the ureter was observed in 3, 4 and 3 males and 5, 1 and 2 females in the 100, 300 and 1000 mg/kg groups, respectively, and the number of occurrences significantly increased in the male 100 mg/kg group. However, dilation of the ureter in the female 100 mg/kg group was observed in litters in 4 of 5 animals.
Other findings included thymic remnant in the neck in 3, 1, 2 and 3 male animals in the control, 100, 300 and 1000 mg/kg groups and in 1, 2 and 2 female animals in the control, 100 and 300 mg/kg groups, nodes in the liver in 1 animal each in the male and female 1000 mg/kg groups, white patches in the liver in 1 animal in the male 100 mg/kg group, pyelectasia in 3 animals each in the male 100, 300 and 1000 mg/kg groups and in 2 and 1 animal in the female 300 and 1000 mg/kg groups, anophthalmia in 1 animal in the female 300 mg/kg group, cysts in the hindlimbs in 1 animal in the female 100 mg/kg group and polydactyly in 1 animal in the female 300 mg/kg group. - Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: n.a.
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- other: visceral and external malformation, body weight
- Description (incidence and severity):
- low incidence and severity
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 100 mg/kg bw/day
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects in the absence of maternal toxicity effects
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- The NOAEL for reproduction/developmental toxicity was considered to be 1000 mg/kg bw/day.
- Executive summary:
Method
The study was conducted according to an OECD combined repeated dose toxicity study with the reproduction/developmental toxicity screening test guideline [TG 422] [MHLW, Japan: 2002] under GLP.
During the test Crj: CD (SD) IGS rats (12 animals/sex/dose) were administered with the test article by gavage at doses of 0 (vehicle: distilled water), 100, 300, or 1000 mg/kg bw/day. Males were dosed for 52 days from day 14 before mating and females were dosed from day 14 before mating to day 4 of lactation throughout the mating and pregnancy period.
Observations
No compound-related effects on the estrous cycle, copulation index, fertility index, gestation length, gestation index, number of corpora lutea, or number of implantation sites were found in dams. No compoundrelated effects on the number, sex ratio, or viability were observed in pups on days 0 and 4 of lactation. Anophthalmia and polydactyly were observed in one pup at 300 mg/kg bw/day. These anomalies are considered to be spontaneous, because the incidences of these anomalies were extremely low and these are of types seen in historical control data. There were no compound-related changes in body weights of pups. No abnormal findings considered to be attributable to administration of this compound were observed in dead pups during lactation and pups at scheduled sacrifice.
Results
Based on these findings, the NOAEL of test item for reproduction/developmental toxicity was considered to be 1000 mg/kg bw/day in rats.
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- OECD SIDS - Disodium Succinate CAS N°: 150-90-3
- Year:
- 2 003
- Bibliographic source:
- UNEP publications
- Reference Type:
- other: reference
- Title:
- n.a.
- Author:
- Ministry of Health, Labor and Welfare (MHLW)
- Year:
- 2 002
- Bibliographic source:
- Toxicity Testing Reports of Environmental Chemicals 9, 383-412
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- RA Substance 1
- IUPAC Name:
- RA Substance 1
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Details on mating procedure:
- Premating exposure period: 14 days
- Duration of treatment / exposure:
- Males: 52 days
Females: from 14 days before mating to day 4 of lactation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Vehicle control
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 12 animals/sex/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: P0 (first parental generation)
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In the observation of estrous cycle, there was no intergroup difference in the mean estrous cycle. The abnormal estrous cycle was observed in 1 animal each in the 100 and 1000 mg/kg groups. There was no intergroup difference in the incidence of abnormal estrous cycle.
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Copulation and conception were all established, and both the copulation index and the fertility index were 100 % in all groups.
There was no abnormality in the numbers of corpora lutea, implantation sites
Details on results (P0)
The gestation period was significantly shortened in the 100 and 1000 mg/kg groups compared with the control group. There was no abnormality in the conditions of parturition, and the numbers of corpora lutea, implantation sites, delivered offspring and live delivered offspring showed almost the same values. There were no intergroup differences in the delivery index, implantation index, parturition index, live birth index, sex ratio and viability index of neonates on day 4 of lactation.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: n.a.
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Body weight during lactation period was significantly low on days 0 and 4 of lactation in males and day 4 in females in the 100 mg/kg group and on day 4 in males in the 300 mg/kg group, which was the change not associated with the dose.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No abnormal findings considered to be attributable to administration of this compound were observed in dead pups during lactation and pups at scheduled sacrifice.
In the necropsy of dead offspring during the lactation period, pyelectasia was observed in 1 animal in the 100 mg/kg group.
In the necropsy on day 4 of lactation, red patches on the plantar were observed in 15 males and 13 females in the 100 mg/kg group, and the number of occurrences significantly increased in both males and females compared with the control group. However, this finding occurred in litters in 2 broods in both males and females. In addition, dilation of the ureter was observed in 3, 4 and 3 males and 5, 1 and 2 females in the 100, 300 and 1000 mg/kg groups, respectively, and the number of occurrences significantly increased in the male 100 mg/kg group. However, dilation of the ureter in the female 100 mg/kg group was observed in litters in 4 of 5 animals.
Other findings included thymic remnant in the neck in 3, 1, 2 and 3 male animals in the control, 100, 300 and 1000 mg/kg groups and in 1, 2 and 2 female animals in the control, 100 and 300 mg/kg groups, nodes in the liver in 1 animal each in the male and female 1000 mg/kg groups, white patches in the liver in 1 animal in the male 100 mg/kg group, pyelectasia in 3 animals each in the male 100, 300 and 1000 mg/kg groups and in 2 and 1 animal in the female 300 and 1000 mg/kg groups, anophthalmia in 1 animal in the female 300 mg/kg group, cysts in the hindlimbs in 1 animal in the female 100 mg/kg group and polydactyly in 1 animal in the female 300 mg/kg group.
Details on results (F1)
to be spontaneous, because the incidences of these anomalies were extremely low and these are of types seen in historical control data.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: n.a.
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for reproduction/developmental toxicity was considered to be 1000 mg/kg bw/day.
- Executive summary:
Method
The study was conducted according to an OECD combined repeated dose toxicity study with the reproduction/developmental toxicity screening test guideline [TG 422] [MHLW, Japan: 2002] under GLP.
During the test Crj: CD (SD) IGS rats (12 animals/sex/dose) were administered with the test article by gavage at doses of 0 (vehicle: distilled water), 100, 300, or 1000 mg/kg bw/day. Males were dosed for 52 days from day 14 before mating and females were dosed from day 14 before mating to day 4 of lactation throughout the mating and pregnancy period.
Observations
No compound-related effects on the estrous cycle, copulation index, fertility index, gestation length, gestation index, number of corpora lutea, or number of implantation sites were found in dams. No compound-related effects on the number, sex ratio, or viability were observed in pups on days 0 and 4 of lactation. Anophthalmia and polydactyly were observed in one pup at 300 mg/kg bw/day. These anomalies are considered to be spontaneous, because the incidences of these anomalies were extremely low and these are of types seen in historical control data. There were no compound-related changes in body weights of pups. No abnormal findings considered to be attributable to administration of this compound were observed in dead pups during lactation and pups at scheduled sacrifice.
Results
Based on these findings, the NOAEL of test item for reproduction/developmental toxicity was considered to be 1000 mg/kg bw/day in rats.
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