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EC number: 700-834-1 | CAS number: 9041-08-1
- 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 fertility
Link to relevant study records
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited study summary. Not GLP.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The Sprague-Dawley rats were used in this fertility and reproductive study. The test substance was administered into dorsal region by subcutaneous route. 10 males and 20 females were treated 60 and 14 days, respectively, before mating with each dose of drug; furthermore females only received the treatment from the first day of pregnancy until the weaning of pups (day 23 after delivery).
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Female and male 8 weeks of age
- Weight at study initiation: Female and male weighing 200±10 g
- Housing: The animals were housed in Makrolon cages in an air-conditioned room.
- Diet (e.g. ad libitum): Females received pelletted dry diet Altromin MT and males diet Altromin R.
- Water (e.g. ad libitum): Tap water was available ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23°C
- Humidity (%): 55-60%
- Air changes (per hr): Ventilation was 12 times/h
- Photoperiod (hrs dark / hrs light): Lighting schedule was 12:12 light/dark (from 7:00 a.m. to 7:00 p.m.)
No additional data - Route of administration:
- subcutaneous
- Vehicle:
- physiological saline
- Details on exposure:
- The test substance dissolved in physiological solution and administered by s.c. route at 1, 5, 10 mg/kg/d at a volume of 5 mL/kg into the dorsal region.
- Details on mating procedure:
- - M/F ratio per cage: 1/3
- Length of cohabitation: one night
- Proof of pregnancy: sperm in vaginal smear referred to as day 1 of pregnancy
No additional data - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 10 males and 20 females were treated 60 and 14 days, respectively, before mating with each dose of drug; furthermore females only received the treatment from the first day of pregnancy until the weaning of pups (day 23 after delivery).
- Frequency of treatment:
- Once daily
- Details on study schedule:
- - F1 parental animals not mated until [10] weeks after selected from the F1 litters.
No additional data - Remarks:
- Doses / Concentrations:
1, 5, 10 mg/kg/d
Basis:
actual ingested - No. of animals per sex per dose:
- 10 males and 20 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- None stated
- Positive control:
- None stated
- Parental animals: Observations and examinations:
- None stated
- Oestrous cyclicity (parental animals):
- None stated
- Sperm parameters (parental animals):
- None stated
- Litter observations:
- None stated
- Postmortem examinations (parental animals):
- In each dose group half of the females were sacrificed on day 20 of pregnancy, the remaining pregnant animals were allowed to deliver. On sacrifice of pregnant rats, uterus, dead or viable fetuses and resorptions were observed; visceral and skeletal exam of fetuses was carried out.
- Postmortem examinations (offspring):
- After weaning, 20 females were randomly chosen and mated with non-consanguineous males (up to 10 weeks of age).
On day 20 of pregnancy, half of the females of this progeny, were necropsied and uterus and fetuses were examined for implantation sites, including viable, dead and/or resorbed fetuses.
On 10 females of each group dose was recorded the fertility and on day 20 of gestation the animals were sacrificed. - Statistics:
- The results were statistically analyzed by Student's t-test for independent samples.
- Reproductive indices:
- None stated
- Offspring viability indices:
- None stated
- Clinical signs:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- >= 10 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: The test substance up to 10 mg/kg by s.c. route did not influence the fertility of parents.
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not specified
- Reproductive effects observed:
- not specified
- Conclusions:
- The studies on the fertility and on the reproductive performance in rats, carried out on F0, F1 and F2 progenies, showed that the test substance up to 10 mg/kg by s.c. route did not influence the fertility of parents and the pregnancy of dams; moreover in this study no effects on fetal and peri- and postnatal development of progeny were observed.
Reference
Effect on fertility: via dermal route
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Limited study summary. Not GLP.
Additional information
Low molecular weight test substance given SC to rats at doses up to 10 mg/kg/d did not adversely affect fertility (male or female), conception, or fetal development (Bertoli, 1986).
Justification for selection of Effect on fertility via dermal route:
2 (reliable with restrictions)
Effects on developmental toxicity
Description of key information
The test substance administered to rats during organogenensis period, up to 10 mg/kg, showed no embryotoxic and fetotoxic activity (Bertoli, 1986).
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited study summary. Not GLP.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The Sprague-Dawley rats were used in this teratogenicity study. The test substance was administered into dorsal region by subcutaneous route once daily on days 5-16 of pregnancy.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Female 8 weeks of age, male 10 weeks of age
- Weight at study initiation: Female and male weighing 200±10 g
- Housing: The animals were housed in Makrolon cages in an air-conditioned room.
- Diet (e.g. ad libitum): Females received pelletted dry diet Altromin MT and males diet Altromin R.
- Water (e.g. ad libitum): Tap water was available ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23°C
- Humidity (%): 55-60%
- Air changes (per hr): Ventilation was 12 times/h
- Photoperiod (hrs dark / hrs light): Lighting schedule was 12:12 light/dark (from 7:00 a.m. to 7:00 p.m.)
No additional data - Route of administration:
- subcutaneous
- Vehicle:
- physiological saline
- Details on exposure:
- The test substance was dissolved in physiological solution and administered into dorsal region, by subcutaneous route, at 1-10 mg/kg at a volume of 5 mL/kg. For comparison was used conventional heparin (H) with activity of 163 USP/mg at 1-10 mg/kg by s.c. route (5 mL/kg).
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - M/F ratio per cage: 1/3
- Length of cohabitation: one night
- Proof of pregnancy: sperm in vaginal smear referred to as day 1 of pregnancy
No additional data - Duration of treatment / exposure:
- On days 5-16 of pregnancy.
- Frequency of treatment:
- Once daily
- Duration of test:
- 21 days
- Remarks:
- Doses / Concentrations:
1, 10 mg/kg
Basis:
actual ingested - No. of animals per sex per dose:
- 10 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- None stated
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: During the gestation the animals were daily observed for any changes in appearance or behaviour and mortality.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: During the gestation the animals were daily observed for any changes in appearance or behaviour and mortality.
BODY WEIGHT: Yes
- Time schedule for examinations: Body weight was measured at selected intervals (1, 7, 14, 21 days).
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 21
- Organs examined: The uterus and the fetuses were examined, the number and location of viable, dead and resorbed fetuses were recorded.
No additional data - Ovaries and uterine content:
- None stated
- Fetal examinations:
- Viable fetuses were weighed, examined externally and the cranial, thoracic and abdominal organs were examined by dissection.
The skeletons were examined after they had been fixed in 70% alcohol, cleared with potassium hydroxide and stained with alizarin red-S. - Statistics:
- The results were statistically analyzed by Student's t-test for independent samples.
- Indices:
- None stated
- Historical control data:
- None stated
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
The test substance administered to rats during organogenensis period, up to 10 mg/kg, showed no embryotoxic and fetotoxic activity, since the drugs did not make a change, in comparison to the controls, in number of implantation sites, resorptions and fetal mortality. - Dose descriptor:
- NOAEL
- Effect level:
- >= 10 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: other:
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Visceral and skeletal macroscopic alterations did not appear in the living fetuses.
No differences from controls were reported in appearance, behaviour or body weight of the dams up to 10 mg/kg/d. - Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- The test substance administered to rats during organogenensis period, up to 10 mg/kg, showed no embryotoxic and fetotoxic activity, since the drugs did not make a change, in comparison to the controls, in number of implantation sites, resorptions and fetal mortality.
Reference
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Limited study summary. Not GLP.
Additional information
2 (reliable with restrictions)
Justification for classification or non-classification
Based on the outcome of the studies the test substance does not need to be classified for reproductive and/or developmental effects.
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.
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