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EC number: 202-676-4 | CAS number: 98-52-2
- 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:
- fertility, other
- Remarks:
- Organogenesis
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from NTP
Data source
Reference
- Reference Type:
- other: Authorized database
- Title:
- Developmental Toxicity of D-Camphor in Sprague Dawley (CD) Rats
- Author:
- NTP
- Year:
- 1 992
- Bibliographic source:
- National Toxicology program (NTP), March 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Developmental Toxicity of D-Camphor in Sprague Dawley (CD) Rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- D-Camphor
- Cas Number:
- 464-49-3
- Molecular formula:
- C10H16O
- IUPAC Name:
- D-Camphor
- Details on test material:
- - Name of test material (as cited in study report): D-Camphor
- Molecular formula (if other than submission substance): C10H16O
- Molecular weight (if other than submission substance): 152.2354 g/mole
- Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): D-Camphor
- Molecular formula (if other than submission substance): C10H16O
- Molecular weight (if other than submission substance): 152.2354 g/mole
- Substance type: Organic
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on mating procedure:
- Pregnant female rats were used.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 10 days (gd 6-15).
- Frequency of treatment:
- Daily
- Details on study schedule:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 400 mg/kg bw/day
- Dose / conc.:
- 800 mg/kg bw/day
- No. of animals per sex per dose:
- not specified
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose was selected based on previous reports indicated that 1250 mg/kg/day CAM causes 90% maternal mortality.
- Positive control:
- not specified
Examinations
- Parental animals: Observations and examinations:
- Survival, Clinical sign, Body weight and weight gain, food consumption and water consumption were examined.
- Oestrous cyclicity (parental animals):
- not specified
- Sperm parameters (parental animals):
- not specified
- Litter observations:
- Fetal growth and viability were examined.
- Postmortem examinations (parental animals):
- Organ weight was examined.
- Postmortem examinations (offspring):
- External, visceral and skeletal malformations were examined.
- Statistics:
- not specified
- Reproductive indices:
- not specified
- Offspring viability indices:
- not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality were observed in treated male and female rats as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Decreased weight gain during the treatment period was observed in treated female rats as compared to control.
Although maternal body weights in all treatment groups were within 5% of control values at all gestational ages, maternal weight gain during the treatment period in the 800 mg/kg/day group was significantly reduced. - Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food consumption was initially suppressed by both 400 and 800 mg/kg/day. But recovered to control levels by the end of the treatment period. No effect on food consumption was seen at 100 mg/kg/day CAM.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Increased maternal water consumption during one or more of the following measurement periods (gd 6 to 9; gd 12 to 15; gd 15 to 18) were observed
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effect on reproductive performance or fetal growth was observed in treated rats as compared to control.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 800 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- mortality
- body weight and weight gain
- food consumption and compound intake
- organ weights and organ / body weight ratios
- reproductive performance
- Remarks on result:
- other: No effect observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effect on viability of fetus were observed as compared to control.
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No external abnormality were observed in pups as compared to control.
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- No visceral and skeletal malformations were observed in pups as compared to control.
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 800 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- gross pathology
- histopathology: non-neoplastic
- Remarks on result:
- other: No effect observed
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 800 mg/kg bw for P and F1 generation when Sprague Dawley and female rats were treated with D-Camphor orally by gavage for 10 days (gd 6-15).
- Executive summary:
In a Developmental Toxicity study, Sprague Dawleyfemale rats were treated withD-Camphorin the concentration of0, 100, 400 and 800 mg/kg bw/dayorally by gavage for10 days (gd 6-15). No mortality were observed in treated dams as compared to control.Decreased weight gain during the treatment period was observed in treated female rats as compared to control. Although maternal body weights in all treatment groups were within 5% of control values at all gestational ages, maternal weight gain during the treatment period in the 800 mg/kg/day group was significantly reduced. Food consumption was initially suppressed at 400 and 800 mg/kg/day. But recovered to control levels by the end of the treatment period. No effect on food consumption was observed at 100 mg/kg/day. Increased maternal water consumption during one or more of the following measurement periods (gd 6 to 9; gd 12 to 15; gd 15 to 18) was observed. Similarly, No effect onreproductive performanceor fetal growth was observed in treated rats as compared to control.Absolute and relative liver weights exhibited a significant dose-related increase, but did not exceed 10% of control values in any individual group. In addition, Noeffect on viability of fetus was observed as compared to control. No external, visceral and skeletal malformations were observed in pups as compared to control. Therefore, NOAEL was considered to be 800 mg/kg bw for P and F1 generation whenSprague Dawleyand female rats were treated withD-Camphororally by gavage for10 days (gd 6-15).
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