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EC number: 200-198-0 | CAS number: 54-21-7
- 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
- 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 a peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Maternal reproductive effects of the given test chemical in Sprague-Dawley rats
- Author:
- Davis et al.
- Year:
- 1 996
- Bibliographic source:
- Toxicology Letters
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Pregnant rats were exposed to the test chemical during gestation to investiagte potential toxicological effects on reproduction and development.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Sodium salicylate
- EC Number:
- 200-198-0
- EC Name:
- Sodium salicylate
- Cas Number:
- 54-21-7
- Molecular formula:
- C7H6O3.Na
- IUPAC Name:
- sodium salicylate
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):sodium salicylate
- Molecular formula :C7H6O3.Na
- Molecular weight : 160.1035 g/mol
- Substance type: organic
- Physical state: solid
- Smilies notation: c1(c(cccc1)O)C(=O)[O-].[Na+]
- InChI: 1S/C7H6O3.Na/c8-6-4-2-1-3-5(6)7(9)10;/h1-4,8H,(H,9,10);/q;+1/p-1
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- Details on test animals and env. conditions
TEST ANIMALS
- Source: Charles River Laboratories
(Portage, MI).
- Age at study initiation: 63 days
- Weight at study initiation: 182-263g
- Fasting period before study: No data available
- Housing: The animals were housed individually
- Use of restrainers for preventing ingestion (if dermal): yes/no
- Diet (e.g. ad libitum): Food (Certified Rodent
Chow 5002, Purina Mills, Inc., St. Louis, MO) ad libitum
.
- Water (e.g. ad libitum): water were provided ad libitum
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C):21.11±1.2 °C
- Humidity (%):57±3.8%
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous methyl cellulose
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS:
Test chemical was mixed with 0.5% aqueous methyl cellulose to form dosing solution
DIET PREPARATION
- Rate of preparation of diet (frequency):No data available
- Mixing appropriate amounts with (Type of food )
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Test chemical was mixed with 0.5% aqueous methyl cellulose
- Concentration in vehicle: 0, 20, 80 or 200 mg/kg bw/day
- Amount of vehicle (if gavage): 10ml/kg
- Lot/batch no. (if required): No data available
- Purity: No data available
Other :
One-half of the dose was given to the animals in the morning and the second half 6-8 h later - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No Data Available
- Details on mating procedure:
- - Impregnation procedure: [artificial insemination / purchased timed pregnant / cohoused]
- If cohoused: No Data Available
- M/F ratio per cage: 1:1
- Length of cohabitation: No Data Available
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: [no / yes (explain)]
- Verification of same strain and source of both sexes: [yes / no (explain)]
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy:The occurrence of copulation was determined by daily inspection for a copulatory plug. The day at which evidence of mating was detected was designated gestation day 0,
- Any other deviations from standard protocol: No Data Available - Duration of treatment / exposure:
- Gestation day 15 to 21.
- Frequency of treatment:
- Twice daily. One half of the dose was given in the morning and the second half 6-8 hours later.
Doses / concentrations
- Remarks:
- 0, 20, 80 or 200 mg/kg bw/day
- No. of animals per sex per dose:
- Total: 86 animals
0 mg/kg bw/day: 25 animals
20 mg/kg bw/day: 25 animals
80 mg/kg bw/day:25 animals
200 mg/kg bw/day: 16 animals - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose were determined in pilot study using an identical protocol which yielded an effect level of 200 mg/ kg/day and a NOEL of less than 100 mg/kg/day for oral exposure to the test chemical.
- Rationale for animal assignment (if not random):
- Other:
Examinations
- Maternal examinations:
- Parental animals observation and examinations
CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
Time schedule: The animals were observed twice daily throughout the study for mortality and signs of overt toxicity.
BODY WEIGHT: Yes
Time schedule for examinations: Individual body weights were recorded on gestation days 0, 6, 15, 16, 17, 18, 19, 20 and 21.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No
Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
Time schedule for examinations: - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: No data
- Number of implantations: Yes
- Number of early resorptions: No data
- Number of late resorptions: No data
- Other: No Data - Fetal examinations:
- Litters were examined for numbers of live and stillborn pups and gross abnormalities. The pups were sexed and weighed individually on lactation day 0.
- Statistics:
- All measured parameters were subjected to Bartlett’s test for hlomogeneity of variance. Then all treatment groups and the vehicle-treated control
group were compared by one-way analysis of variance (ANOVA). Pairwise comparisons were made using the appropriate t-test (for equal and unequal variance) as described by Steel and Torrie using Dunnett’s multiple comparison tables, or pairwise comparisons were made with a Bonferroni correction to determine the significance. - Indices:
- No data available
- Historical control data:
- No data available
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Clinical signs of maternal physical distress during parturition included labored breathing, decreased activity, and blood staining in the abdominal, nasal, and oral areas. No evidence of increased maternal distress was noted in animals from either the mid-dose (80 mg/kg/day) or low-dose (20 mg/kg/day).
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- The incidence of maternal perinatal death was significantly increased at 200 mg/kg compared to the control group. That is, 4 of 10 animals at 200 mg/kg died or had to be sacrificed due to extreme distress whilst only 1 of 21 animals treated at 0 mg/kg died perinatally. At 20 or 80 mg/kg/day, no evidence of increased peripatum mortality was noted.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effects on gestational body weight gain .
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Treatment at 200 mg/kg resulted in a significant increase in labor duration compared to control data (mean, ≈3.5 hours at 200 mg/kg vs. mean, ≈1.2 hours at 0 mg/kg). Gestation length was unaffected by treatment.
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- not examined
- Total litter losses by resorption:
- not examined
- Early or late resorptions:
- not examined
- Dead fetuses:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A non-statistical increase in fetal peripartum deaths was reported at 200 mg/kg compared to the control group (9.7% fetuses affected at 200 mg/kg vs 3.1% of fetuses affected at 0 mg/kg).
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- Gestation length was unaffected by treatment.
- Changes in number of pregnant:
- no effects observed
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 80 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical signs
- dead fetuses
- effects on pregnancy duration
- mortality
- other: labor duration
- Remarks on result:
- other: No toxic effects observed
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- <= 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- mortality
- other: labor duration
- Remarks on result:
- other: effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A non-statistical increase in fetal peripartum deaths was reported at 200 mg/kg compared to the control group (9.7% fetuses affected at 200 mg/kg vs 3.1% of fetuses affected at 0 mg/kg).
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- Sex ratio was unaffected by treatment.
- Changes in litter size and weights:
- no effects observed
- Description (incidence and severity):
- No significant effects were observed on mean pups per litter or mean pup weight.
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Description (incidence and severity):
- No external visible abnormalities were observed in any of the pups that survived delivery. Gross examination was not performed on fetuses that died peripartum.
- Skeletal malformations:
- not examined
- Visceral malformations:
- not examined
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- 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
- external malformations
- Remarks on result:
- other: No toxic effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
- Treatment related:
- no
Applicant's summary and conclusion
- Conclusions:
- NOAEL for developmental toxicity was considered at 200 mg/kg bw/day in pregnant female rats follwoing exposure to the test chemical from gestation day 15 to 21.
- Executive summary:
Pregnant female rats were treated with the test chemical by oral gavageat 0, 20, 80 and 200 mg/kg bw/day from day 15 to 21 of gestation. Twenty-five rats were used per dose level up to 80 mg/kg whereas sixteen rats were used at 200 mg/kg. No significant effects were observed on gestational body weight gain and no signs of toxicity were observed until onset of delivery. Treatment at 200 mg/kg resulted in a significant increase in labor duration compared to control data (mean, ≈3.5 hours at 200 mg/kg vs. mean, ≈1.2 hours at 0 mg/kg). Gestation length was unaffected by treatment. A non-statistical increase in fetal peripartum deaths was reported at 200 mg/kg compared to the control group (9.7% fetuses affected at 200 mg/kg vs 3.1% of fetuses affected at 0 mg/kg). No significant effects were observed on mean pups per litter, live pups per litter, mean pup weight, or sex ratio. No external visible abnormalities were observed in any of the pups that survived delivery. Gross examination was not performed on fetuses that died peripartum. The incidence of maternal perinatal death was significantly increased at 200 mg/kg compared to the control group. That is, 4 of 10 animals at 200 mg/kg died or had to be sacrificed due to extreme distress whilst only 1 of 21 animals treated at 0 mg/kg died perinatally. NOAEL for developmental toxicity was considered at 200 mg/kg bw/day in pregnant female rats follwoing exposure to the test chemical from gestation day 15 to 21.
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