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EC number: 280-622-9 | CAS number: 83732-72-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06.10.2004 - 02.03.2005
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 83732-72-3
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Han Wistar
- Details on test animals or test system and environmental conditions:
- Acclimatization: Five days prior to pairing under test conditions with an evaluation of the health status
Number of animals: 88 mated females*, 22 per group (*In order to complete mating within a reasonable time period, 98 female rats were obtained from the breeder. The surplus females were killed after commencement of treatment tor the last mated females.)
Age at pairing: 11 weeks
Body weights (day 0 post coitum): 196 - 240 grams
Identifiation (day 0 post coitum): Individual cage card and animal number tattooed on the pinnae.
HUSBANDRY
Conditions:
Animals were housed under standard laboratory conditions: air-conditioned with 10-15 air changes per hour; the environment monitored continuously with recordings of temperature (target range 22 ± 5°C) and relative humidity (target range 30 - 70%), 12 hours artificial fluorescent light / 12 hours dark with background music played at a centrally defined low volume for at least 8 hours during the light period.
Accomodation:
Animals were housed individually in Makroion cages (type-3) with wire mesh tops and standardized granulated softwood bedding (Lignocel, Schill AG, CH-4132 Muttenz/Switzerland).
Diet:
Pelleted standard Kliba-Nafag 3433 rat/mouse maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst/ Switzerland) was available ad libitum.
Water:
Community tap water from Füllinsdorf in bottles was available ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Ultrapure water
- Details on exposure:
- A standard dose volume of 10 mUkg body weight with a daily adjustment to the actual body weight was used.
- Duration of treatment / exposure:
- Day 6 through to day 20 post coitum, inclusive.
- Frequency of treatment:
- once daily
- Duration of test:
- 21 days (post coitum)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Group 1 (vehicle control)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Remarks:
- Group 2
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- Group 3
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Remarks:
- Group 4
- No. of animals per sex per dose:
- 22 mated female rats
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- changes in number of pregnant
- changes in pregnancy duration
- clinical biochemistry
- clinical signs
- dead fetuses
- early or late resorptions
- effects on pregnancy duration
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: neoplastic
- maternal abnormalities
- mortality
- necropsy findings
- number of abortions
- ophthalmological examination
- organ weights and organ / body weight ratios
- pre and post implantation loss
- total litter losses by resorption
- urinalysis
- water consumption and compound intake
Results (fetuses)
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- fetal/pup body weight changes
- changes in litter size and weights
- changes in postnatal survival
- external malformations
- skeletal malformations
- visceral malformations
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
- Treatment related:
- no
- Dose response relationship:
- no
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In order to detect effects on the pregnant female and on embryonic and fetal development A 130 was administered orally by gavage once daily from day 6 through to day 20 post coitum at dose levels of 0, 50, 100 and 200 mg/kg body weight/day.
Treatment with the test item at 100 and 200 mg/kg body weight/day resulted in clinical signs (ruffled fur), dose-dependently reduced mean food consumption and body weight gain.
Based on these results the NOEL (no observed effect level) for maternal organisms was considered to be 50 mg/kg body weight/day.
The NOEL (no observed effect level) for fetal organisms was considered to be 200 mg/kg body weight/day.
Up to and including the high dose of 200 mg/kg body weight/day, A 130 revealed no teratogenic potential. - Executive summary:
The purpose of this study was to assess the effects of A 130 on the pregnant female rat and development of the embryo and fetus when administered orally by gavage once daily to mated female rats from day 6 through to day 20 post coitum, inclusive. Each group consisted of 22 mated female rats. A 130 was administered once daily at dose levels of:
Group 1: 0 mg/kg body weight/day (vehicle control)
Group 2: 50 mg/kg body weight/day
Group 3: 100 mg/kg body weight/day
Group 4: 200 mg/kg body weight/day
A standard dose volume of 10 mL/kg body weight with a daily adjustment to the actual body weight was used. Control animals were dosed with the vehicle alone (ultrapure water).
All females were sacrificed on day 21 post coitum and the fetuses were removed by Caesarean section. Examination of dams and fetuses was performed in accordance with international recommendations.
The following results were obtained:
MATERNAL DATA
General Tolerability
All females survived until scheduled necropsy.
At 100 and 200 mg/kg/day, ruffled fur and signs of discomfort following administration were noted for all females on most days of the treatment period.
No test item-related macroscopic findings were noted during necropsy of dams.
Food Consumption and Body Weights
At 100 and 200 mg/kg/day, mean food consumption and body weight gain was dosedependently reduced during the treatment period. Also corrected body weight gain (corrected for gravid uterus weight) was dose-dependently reduced at these dosages.
Reproduction Data
Post-implantation losses and the mean number of fetuses per dam were unaffected by treatment with the test item at all dose levels.
FETAL DATA
Sex Ratios and Body Weights
No test item-related effects on fetal sex ratios were noted in any group.
Mean fetal body weights were similar in all groups and gave no indication of a test itemrelated eff ect.
External Examination
No abnormalities that were considered to attributable to treatment with the test item were noted during fetal external
examination.
Visceral Examination
No test item-related findings were noted during fetal visceral examination.
Skeletal and Cartilage Examination
No test item-related findings were noted during fetal skeletal and cartilage examination.
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