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EC number: 283-144-9 | CAS number: 84540-50-1
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07.03. - 05.04.1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
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:
- 3-amino-2-chlor-6-methylphenol
- EC Number:
- 283-144-9
- EC Name:
- 3-amino-2-chlor-6-methylphenol
- Cas Number:
- 84540-50-1
- Molecular formula:
- C7H8ClNO
- IUPAC Name:
- 3-amino-2-chloro-6-methylphenol
- Test material form:
- solid: crystalline
- Details on test material:
- cream colored
1
Test animals
- Species:
- rat
- Strain:
- other: Wistar/HAN
- Details on test animals or test system and environmental conditions:
- Number of animals: 100 mated females
Age: 11 weeks, minimum
Body weight: 186-234 g
Acclimatization: 7 days minimum
Conditions:
The animals were housed under standard laboratory conditions:
air-conditioned with 10-15 air changes per hour; the environment monitored continuously with hourly recordings of temperature
(range 22 +/- 3 degrees Centigrade) and humidity (range 40 - 70 1.); 12 hours artificial fluorescent light/12 hours dark with background music (Schweizerischer Telefonrundspruch) played at a centrally defined low volume for at least 8 hours during the light period.
Accommodation:
The animals were housed individually in Makrelen cages (type-3) with wire mesh tops and standardised granulated softwood
bedding Clignocel, Schill AG, CH 4132 Muttenz I Switzerland).
Diet:
N Pelleted standard Kliba 343 rat/mouse maintenance diet c·Kliba Klingentalmuehle AG, CH 4303 Kaiseraugst/Switzerland) was available ad libitum (Batch no. 91/88). Results of analyses for contaminants are attached Cpp. 90,91).
Water:
Tap water in bottles was available ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on exposure:
- dose volume of 10 ml/kg body weight
- Details on mating procedure:
- After acclimatization, the females were paired overnight with sexually mature males, in the ratio of 1 male: 1 female. The day on which spermatozoa were found in the vaginal smear or a vaginal plug was observed was designated day 0 post coitum.
- Duration of treatment / exposure:
- day 6 through to day 15 post coitum
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- group 1 (vehicle control)
- Dose / conc.:
- 30 mg/kg bw/day (nominal)
- Remarks:
- group 2
- Dose / conc.:
- 90 mg/kg bw/day (nominal)
- Remarks:
- group 3
- Dose / conc.:
- 270 mg/kg bw/day (nominal)
- Remarks:
- group 4
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 90 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
Results (fetuses)
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 270 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- fetal/pup body weight changes
- external malformations
- skeletal malformations
- visceral malformations
Fetal abnormalities
- Key result
- Abnormalities:
- effects observed, non-treatment-related
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
- Treatment related:
- no
Applicant's summary and conclusion
- Conclusions:
- Oral administration of Ro 543 to pregnant female rats between days 6 and 15 post coitum caused slightly reduced food consumption and body weight gain at the highest dose level of 270 mg/kg body weight/day.
Based on these results, the no-observable effect level for the maternal organism was 90 mg/kg body weight/day.
Ro 543 did not reveal any embryotoxic or teratogenic potential up to the highest dose level of 270 mg/kg body weight/day when administered to pregnant Wistar rats under the conditions described for this study . - Executive summary:
The purpose of this study was to assess the effects of Ro 543 on embryonic and fetal development in pregnant Wistar/HAN rats. Each group consisted of 25 mated female rats. Ro 543 was administered orally by gavage once daily from day 6 through to day 15 post coitum, at dose levels of:
Group 1: 0 mg/kg body weight/day (vehicle control)
Group 2: 30 mg/kg body weight/day
Group 3: 90 mg/kg body weight/day
Group 4: 270 mg/kg body weight/day
The dosages were based on the results of the dose rangefinding study (RCC Project 204480). 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 (distilled water).
Females were sacrificed on day 21 post coitum and the fetuses were removed by Caesarean section. The examination of the dams and fetuses was performed in accordance with international recommendations.
The following results were obtained:
Treatment with Ro 543 did not influence the viability or the behavior and appearance of the animals in any dose group during the entire study. At necropsy, no abnormal findings were observed which could be attributed to treatment with the test article.
Oral administration of Ro 543 caused significantly reduced mean food consumption in the dams of group 4 (270 mg/kg) during the treatment period. In correlation with this finding, mean body weight gain of the group 4 dams was slightly reduced (mainly in the early days of the treatment period). The marginally reduced mean corrected body weight gain was also considered to be treatment-related.
No treatment-related differences between the vehicle control group and any dose group were noted for any of the reproduction parameters. During external examination of the fetuses, no malformations or anomalies were noted which could be attributed to treatment with the test article. The single fetus with malrotated hind limbs in group 3 (90 mg/kg) and the runt with palatoschisis in group 4 (270 mg/kg) were considered to be incidental.
Visceral and skeletal examination of the fetuses gave no indication of treatment-related effects. The differences noted were within the normal range of variation for this rat strain.
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