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EC number: 205-413-1 | CAS number: 140-39-6
- 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:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data from NTP study report.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Methyl Salicylate: Reproduction and Fertility Assessment in CD-l Mice When Administered by Gavage
- Author:
- Environmental Health Research and Testing, Inc
- Year:
- 1 984
- Bibliographic source:
- National Toxicology Program, Research Triangle Park, NC. NTP85-022 - PB85-l64283, 1984, page no 1- 165
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: According to Fertility Assessment by Continuous Breeding (FACB) protocol
- Principles of method if other than guideline:
- Reproduction and fertility assessment of methyl salicylate in CD-1 mice when administered by gavage.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Methyl salicylate
- EC Number:
- 204-317-7
- EC Name:
- Methyl salicylate
- Cas Number:
- 119-36-8
- Molecular formula:
- C8H8O3
- IUPAC Name:
- Methyl 2-hydroxybenzoate
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report):Methyl Salicylate
- Molecular formula : C8H8O3
- Molecular weight : 152.14 g/mole
- Substance type: Oragnic
- Physical state:Liquid
- Impurities (identity and concentrations): < 1 %
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Fisher Scientific Co.
(Lot #703535)
- Expiration date of the lot/batch: No data
- Purity: >/= 99%
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratory Inc. (Kingston, N.Y.).
- Age at study initiation: (P) x wks; (F1) x wks: F0: 11 weeks
F1: 70 ± 10 days
- Weight at study initiation: (P) Males: x-x g; Females: x-x g; (F1) Males: x-x g; Females: x-x g: F0: male- 34.5 ± 0.58 to 35.6 ± 0.76g , Female: 26.3 ± 0.66 to 27.6 ± 0.60g
F1: male- 1.65 ± 0.014 to 1.60 ± 0.023g, female: 1.53 ± 0.016 to 1.60 ± 0.014g
- Fasting period before study: No data available
- Housing: Animals were housed 2 per Polycarbonate shoebox type cages (5" x 11" x 7") with stainless steel wire bar lids, one of these animals will be punched in the left ear for identification purposes. Cages will be uniformly placed on stainless steel racks (66" x 60" x 30"). Cages will be rotated (relative placement) at least once a week. Bedded on Ab-Sorb-Dri , Approximately 100g of bedding will be used per cage.
- Diet (e.g. ad libitum): Purina certified Rodent Chow animal diet #5002, ad libitum.
- Water (e.g. ad libitum): Water, ad libitum.
- Acclimation period: F0: 1 week , F1: five weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25° C
- Humidity (%):20 to 70%
- Air changes (per hr): 10 or more air changes per hour of HEPA-filtered air.
- Photoperiod (hrs dark / hrs light): 14 hour light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dosing solutions were formulated by mixing the test article directly into different proportions of corn oil.
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food:No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): Corn oil
- Concentration in vehicle: 0, 0.1, 0.25, and 0.5 g/kg
- Amount of vehicle (if gavage): 10 mL/kg
- Lot/batch no. (if required): No data
- Purity:No data - Details on mating procedure:
- - M/F ratio per cage:1: 1 ratio
- Length of cohabitation: 100 days
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy: No data available
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility.: No data available
- Further matings after two unsuccessful attempts: No data available
- After successful mating each pregnant female was caged (how): Individually
- Any other deviations from standard protocol: Litters produced during the cohabitation period (day 7 to day 107) will be humanely sacrificed. Litters produced during the period day 107 to day 127 will be allowed to remain with their mothers - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 127 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.1, 0.25 and 0.50 g/kg (0, 100, 250 and 500 mg/kg/day)
Basis:
no data
- No. of animals per sex per dose:
- Total: 200
0 mg/kg/day: 40 male, 40 female
100 mg/kg/day: 20 male, 20 female
250 mg/kg/day: 20 male, 20 female
500 mg/kg/day: 20 male, 20 female - Control animals:
- yes, concurrent vehicle
- Positive control:
- No data avaialble
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS:No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations:No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OTHER: Mortality: Yes - Oestrous cyclicity (parental animals):
- No data availavble
- Sperm parameters (parental animals):
- No data availavble
- Litter observations:
- Number and percent of live pups per litter and Mean body weight of live offspring, Proportion of pups born alive and sex of pups born alive were observed.
- Postmortem examinations (parental animals):
- No data availavble
- Postmortem examinations (offspring):
- Pattern of testicular descendency in male pups were observed.
- Statistics:
- Statistical analysis wre performed by using Pairwise comparisons for Fertility of Pairs During Continuous Breedins, Litters per Fertile Pair and Litter Size (Live offsprins) per Fertile Pair by using Chi square Pairwise comparisons .
- Reproductive indices:
- Fertility, No. Fertile/ No. Cohabited and litters per pair were observed.
- Offspring viability indices:
- Viability indices were observed.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment related sign of toxicity were observed in treated rats as compared to control.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Whe treated with 100 and 250 mg/kg/day, 2 male and 2 female were died as compared to control.
Whe treated with 500 mg/kg/day, 4 rats were died as compared to control.
The cause of death varied from case to case but it was neither chemical nor dose related. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect was observed body weight of treated rats as compared to control.
- 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
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- .
Details on results (P0)
Significant decrase in litters per pair, proportion of pups born alive and sex of pups born alive when treated with 500 mg/kg/day as compared to control
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- reproductive performance
- other: No effect observed.
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- 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:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Details on results (F1)
Significant decrase in number of live pups were observed in 500 mg/kg/day.
Body weight:
Significant decrase in live pup weight and adjusted live pup weight was observed in 500 mg/kg/day treated rats as compared to control.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on survival and body weight were observed.
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 250 mg/kg/dy for F0 and F1 generation when CD-1 albino male and female mice were treated wtih methyl salicylate.
- Executive summary:
In a Reproductive toxicity study, CD-1 albino male and female mice were treated with Methyl Salicylate in the concentration of 0, 100, 250 and 500 mg/kg/day by oral gavage. 2 male and 2 female were died in 100 and 250 mg/kg/day dose group and 4 rats were died in 500 mg/kg/day dose group as compared to cont rol.The cause of death varied from case to case but it was neither chemical nor dose related. No treatment related sign of toxicity and change in body weight were observed in treated rats as compared to control. No effect on fertility index were observed but significant decrease in litters per pair, proportion of pups born alive and sex of pups born alive when treated with 500 mg/kg/day as compared to control. In addition, significant decrease in number of live pups, live pup weight and adjusted live pup weight was observed in 500 mg/kg/day treated rats as compared to control. Therefore, NOAEL was considered to be 250 mg/kg/dy for F0 and F1 generation when CD-1 albino male and female mice were treated with methyl salicylate.
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