Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 209-247-0 | CAS number: 563-41-7
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on developmental toxicity
Description of key information
Supporting study: Test substance tested in pregnant S-D rats had teratogenic effects at doses 100, 50 and 25 mg/kg bw. At all mentioned doses was observed cleft palate and resorption, althought the 100% cleft palate and resorption was observed at dose 100 mg/kg bw. The adverse effects were not seen in the mothers nor in the fetuses at the doses of 10 and 5 mg/day.
Supporting study: In another study on developmental toxicity,test substance caused death of hamster females at doses 150 and 200 mg/kg/bw and at the dose of 100 mg/kg/bw was observed minor teratogenic effect.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- No GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- Number of animals in tested group according the TG 414 should be 20 females. In present study, the number of animals was less than 12 in each group.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Female S-D rats 230-260g
- Diet (e.g. ad libitum): diets containing 50% ground sweet pea seeds (Lathyrus odoratus) obtained locally and from Argentina and ground Purina Laboratory Chow at various times at gestation. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:Test substance was administrated to rats in aqueous solutions by oral intubation.
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: Females were mated with fertile males overnight.
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of gestation. - Duration of treatment / exposure:
- During the days of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- During the gestation, after that, the females were killed.
- Dose / conc.:
- 100 mg/kg bw/day
- Remarks:
- Group 1
- Dose / conc.:
- 50 mg/kg bw/day
- Remarks:
- Group 2
- Dose / conc.:
- 25 mg/kg bw/day
- Remarks:
- Group 3
- Dose / conc.:
- 10 mg/kg bw/day
- Remarks:
- Group 4
- Dose / conc.:
- 5 mg/kg bw/day
- Remarks:
- Group 5
- No. of animals per sex per dose:
- 5 groups.
Group number 1: 9 animals (100 mg/kg bw/day)
Group number 2: 8 animals (50 mg/kg bw/day)
Group number 3: 3 animals (25 mg/kg bw/day)
Group number 4: 11 animals (10 mg/kg bw/day)
Group number 5: 4 animals (5 mg/kg bw/day) - Control animals:
- not specified
- Details on study design:
- The administration tested substance in aqueous solution was performed during the days of gestation.
Group number 1, 4 and 5: 12-15 days
Group number 2 and 3: 10-16 days - Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes:mortality
DETAILED CLINICAL OBSERVATIONS: Yes, mortality
- Ovaries and uterine content:
- Uterine content was examined after termination: Yes
- Fetal examinations:
- - External examinations: Yes:cleft palate and resorption
Fetuses were removed from the uterus 1 day before estimated term, examined for gross congenital malformations, and fixed in Bouin’s solution. - Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Three of six pregnant rats treated daily with test substance in doses 100 mg during the days of gestations 12-15 died.
- Body weight and weight changes:
- not examined
- 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:
- 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:
- 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
- Number of abortions:
- not examined
- Pre- and post-implantation loss:
- not examined
- Total litter losses by resorption:
- not examined
- Early or late resorptions:
- not examined
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined - Changes in number of pregnant:
- not examined
- Other effects:
- not examined
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 100 other: mg/day
- Based on:
- test mat.
- Basis for effect level:
- mortality
- Fetal body weight changes:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not examined - Reduction in number of live offspring:
- effects observed, treatment-related
- Description (incidence and severity):
- Yes:
Doses: 100 mg/day 56% of resorption
50 mg/day- 38% of resorption
25 mg/day - 3 % of resorption
10 mg/day - 0 % of resorption
5 mg/day - 3% of resorption - Changes in sex ratio:
- not examined
- Changes in litter size and weights:
- not examined
- Changes in postnatal survival:
- not examined
- External malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- At the dose of 100 mg of tested substance, litters produced by surviving females had resorptions and 100% cleft palate.
At the doses of 25 and 50 mg cleft palate and resorptions were observed also. - Skeletal malformations:
- not examined
- Visceral malformations:
- not examined
- Other effects:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 10 other: mg/day
- Based on:
- test mat.
- Sex:
- not specified
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 25 other: mg/day
- Based on:
- test mat.
- Sex:
- not specified
- Key result
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- external: face
- Description (incidence and severity):
- 100 % Cleft palate - 100 mg/kg
- Key result
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- external: face
- Description (incidence and severity):
- 95% Cleft palate - 50 mg/kg
- Key result
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- external: face
- Description (incidence and severity):
- 43% Cleft palate - 25 mg/kg
- Key result
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 25 other: mg/day
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects in the absence of maternal toxicity effects
- Dose response relationship:
- yes
- Relevant for humans:
- no
- Conclusions:
- Test substance tested in pregnant S-D rats had teratogenic effects at doses 100, 50 and 25 mg/kg bw. At mentioned doses was observed cleft palate and resorption, althought the 100% cleft palate and resorption was observed at dose 100 mg/kg bw. The adverse effects were not seen in the mothers nor in the fetuses at the doses of 10 and 5 mg/day.
- Executive summary:
Test substance was tested on pregnant S-D rats for teratogenic effects. Rats were fed with sweet peas. Female rats (230-260g) were mated with fertile males overnight and checked by vaginal smears for insemination the followong morning. Animals were divided into 5 groups, each one contained different amount of animals which were administrated by test substance in aqueous solution by oral intubatiion during the day of gestation. Test substance was administrated at doses 100,50,25,10 and 5 mg/day. Three animals from the first group administrated at dose 100 mg/day died, but the surviving animals produced litters with resorptions of 56% and 100% cleft palate. Cleft palate and resorptions were also observed at doses 25 and 50 mg/day. At the dose 50 mg/day was observed 38% of resorption and 95% of cleft palate and in dose 25 mg/day 3% of resorption and 43 % of cleft palate. The adverse effects were not seen at the doses of 10 and 5 mg/day.
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- no
- Limit test:
- no
- Species:
- hamster, Syrian
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: High Oak Ranch Ltd, Goodwood, Ont.
- Housing:After mating, gravid animals were kept in single wire cages
- Diet (e.g. ad libitum): Ad libitum,Purina lab Chow
- Water (e.g. ad libitum):ad libitum
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light):12h/12h
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: All injections were given in aqueous solution on day 7 of gestation.
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- The animals were mated from 10.00-12.00 p.m and the following day designed as day 0 of gestation.
- Duration of treatment / exposure:
- One day (only on day 7 of gestation)
- Frequency of treatment:
- Once
- Duration of test:
- 7 days, on day 14 animals were killed
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Untreated
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Vehicle treated controls
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 150 mg/kg bw/day
- Dose / conc.:
- 200 mg/kg bw/day
- No. of animals per sex per dose:
- Not specified
- Control animals:
- yes, concurrent no treatment
- yes, concurrent vehicle
- Details on study design:
- 3 groups: 1. untreated, 2. vehicle treated controls receiving single dose of destilled water and 3. lathyrogen-treated animals.
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes, observation of death.
- Ovaries and uterine content:
- The uterine content was examined after termination: Yes
- Fetal examinations:
- - External examinations: Yes: all per litter
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- At the doses of 150 and 200 mg/kg bw maternal death was observed.
The females generally died within 48 h of administration of test substance. - Body weight and weight changes:
- not examined
- 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:
- 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:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The autopsy revealed gravid uteri with all implantation sites showing signs of resorption.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Number of abortions:
- not examined
- Pre- and post-implantation loss:
- not examined
- Total litter losses by resorption:
- not examined
- Early or late resorptions:
- not examined
- Dead fetuses:
- not examined
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined - Changes in number of pregnant:
- not examined
- Other effects:
- not examined
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 150 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- mortality
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 100 mg/kg bw/day
- Based on:
- test mat.
- Fetal body weight changes:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): Mean fetal weight of live fetuses (79) was not significantly reduced. Mean fetal weight (g) = 2.02+-0.68 (indicates the fetuses weighting less than 60% if the mean weight of the untretaed control fetuses, expressed as percent of live fetuses. - Reduction in number of live offspring:
- effects observed, treatment-related
- Description (incidence and severity):
- At 100 mg/kg bw, 1% of fetal mortality was observed.
- Changes in sex ratio:
- not examined
- Changes in litter size and weights:
- not examined
- Changes in postnatal survival:
- not examined
- External malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- The 5.1% of fetuses had malposition of the fore-and hindlimbs.
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- No skeletal abnormalities at at dose of 100 mg/kg.
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- No visceral abnormalities at dose of 100mg/kg.
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- GROWTH RETARDATION: The 16.5% of lived fetuses showed growth retardation.
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Key result
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- skeletal: forelimb
- skeletal: hindlimb
- Description (incidence and severity):
- Malformations at dose of 100 mg/kg bw
- Key result
- 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:
- yes
- Relevant for humans:
- no
- Conclusions:
- Test substance caused death of hamster females at doses 150 and 200 mg/kg/bw and at the dose of 100 mg/kg/bw was observed minor teratogenic effect.
- Executive summary:
Test substance was tested on hamster for teratogenic effects. Animals were divided into three groups and administrated by test substance in aqueous solution orally by gavage on day 7 of gestation at doses 100, 150 and 200 mg/kg/bw. The animals were killed on gestation day 14 and the contents of the uterus was examined. The two higher doses caused death of all the mothers, usually within 48h of dosing and all implants showed signs of resorptions. At 100 mg/kg bw, 1.3% of implants were dead or resorbed. Of the live fetuses, mean fetal weight was not significantly reduced. The 16.5% of fetuses showed growth retardation. No skeletal of visceral abnormalities were observed, however 5.1% of fetuses had malposition of the fore-and hindlimbs. According the results observed during this study, test substance appears to be mildly teratogenic in gestation and causes death of hamster females at doses 150 and 200 mg/kg/bw.
Referenceopen allclose all
Cleft palate and resorption produced by semicarbazide hydrochloride
No. Of females treated |
Dose mg/day |
Days of gestation administrated |
Resorptions
|
Cleft palate |
||
No. % |
No. % |
|||||
6 |
100 |
12-15 |
28/50 |
56 |
22/22 |
100 |
8 |
50 |
10-16 |
26/68 |
38 |
40/42 |
95 |
3 |
25 |
10-16 |
1/29 |
3 |
12/28 |
43 |
11 |
10 |
12-15 |
0/107 |
0 |
0/107 |
0 |
4 |
5 |
12-15 |
1/33 |
3 |
0/32 |
0 |
3 animals from the first group (dose 100mg/day) died.
No gross external, skeletal or visceral abnormalities were found among the litters of control groups (untreated and vehicle treated). Among the lathyrogen-treated litters, the most striking abnormalities were those of the anterior aspect of the central nervous system.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- K3,the documentation is not sufficient for assessment.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Supporting study:
Test substance was tested on pregnant S-D rats for teratogenic effects. Rats were fed with sweet peas. Female rats (230 -260g) were mated with fertile males overnight and checked by vaginal smears for insemination the followong morning. Animals were divided into 5 groups, each one contained different amount of animals which were administrated by test substance in aqueous solution by oral intubatiion during the day of gestation. Test substance was administrated at doses 100,50,25,10 and 5 mg/day. Three animals from the first group administrated at dose 100 mg/day died, but the surviving animals produced litters with resorptions of 56% and 100% cleft palate. Cleft palate and resorptions were also observed at doses 25 and 50 mg/day. At the dose 50 mg/day was observed 38% of resorption and 95% of cleft palate and in dose 25 mg/day 3% of resorption and 43 % of cleft palate. The adverse effects were not seen at the doses of 10 and 5 mg/day.
Supporting study:
Test substance was tested on hamster for teratogenic effects. Animals were divided into three groups and administrated by test substance in aqueous solution orally by gavage on day 7 of gestation at doses 100, 150 and 200 mg/kg/bw. The animals were killed on gestation day 14 and the contents of the uterus was examined. The two higher doses caused death of all the mothers, usually within 48h of dosing and all implants showed signs of resorptions. At 100 mg/kg bw, 1.3% of implants were dead or resorbed. Of the live fetuses, mean fetal weight was not significantly reduced. The 16.5% of fetuses showed growth retardation. No skeletal of visceral abnormalities were observed, however 5.1% of fetuses had malposition of the fore-and hindlimbs. According the results observed during this study, test substance appears to be mildly teratogenic in gestation and causes death of hamster females at doses 150 and 200 mg/kg/bw.
Justification for classification or non-classification
Some effects has been observed but the data has no good quality for assessment and, therefore, test substance can not be classified for developmental toxicity according to CLP Regulation (EC) no. 1272/2008.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.