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EC number: - | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 August 2014 to 09 September 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF, 12 Nousan, Notification No 8147, November 2000
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., sodium salts
- Molecular formula:
- Na(C21-25H33-41O3)
- IUPAC Name:
- Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., sodium salts
- Test material form:
- other: sticky solid
- Details on test material:
- - Appearance: Green-black solid
- Storage conditions of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Wistar strain Crl:WI (Han) (outbred, SPF-Quality)
- Age at study initiation: Approximately 8 to 9 weeks old
- Weight at study initiation: 147 to 169 g. Body weight variation did not exceed ± 20 % of the sex mean.
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3 to 4 hours after administration of the test material. Water was available ad libitum.
- Housing: Group housing of 3 animals per cage in labelled cages (height 18 cm) containing sterilised sawdust as bedding material and paper as cage-enrichment.
- Diet: Free access to pelleted rodent diet
- Water: Free access to tap water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 to 24 °C
- Humidity: 40 to 70 % (relative)
- Air changes: at least 10 air changes/hour
- Photoperiod: 12-hour light/12-hour dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE:
- Specific gravity: 1.036
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at the testing facility and on test material data.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bodyweight
DOSAGE PREPARATION (if unusual): The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. The concentration of the test material in vehicle was varied to allow constant dosage volume in terms of mL/kg body weight.
In order to obtain homogeneity, the test material formulations were heated in a water bath with a maximum temperature of 77.5 °C for a maximum of 75 minutes. The test material formulations were allowed to cool down to a temperature of maximally 40 °C prior to dosing.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Starting dose = 2000 mg/kg bw. Substance initially assumed to be of low toxicity based on test on amixture containing the substance. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 animals were dosed at 2000 mg/kg bw. 6 animals were dosed at 300 mg/kg bw.
- Control animals:
- no
- Details on study design:
- - Study design: The toxicity of the test material was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups. Initially, the test material was administered at 2000 mg/kg bw. In a stepwise procedure, two additional groups were dosed at 300 mg/kg bw.
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Animals were observed for mortality and viability twice daily. Time of death was recorded as precisely as possible. Body weights were recorded on Day 1 (pre-administration of the test material), Days 8 and 15 and at death (if found dead after Day 1). At periodic intervals on the day of dosing (Day 1) and once daily thereafter until Day 15, animals were observed for clinical signs. The signs were graded according to fixed scales and the time of onset, degree and duration were recorded.
- Necropsy of survivors performed: Yes. At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy.
- Other examinations performed: Descriptions of all internal macroscopic abnormalities were recorded. - Statistics:
- No statistical analysis was performed as the method used is not intended to allow the calculation of a precise LD50 value.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 300 - 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At 2000 mg/kg, two animals were found dead on day 2.
At 300 mg/kg, no mortality occurred. - Clinical signs:
- other: At 2000 mg/kg, hunched posture, piloerection and/or diarrhoea were noted for the animals on Day 1. At 300 mg/kg, hunched posture, piloerection and/or diarrhoea were noted for the animals on Days 1 and 2.
- Gross pathology:
- At 2000 mg/kg, abnormalities of the stomach (glandular mucosa: several dark red foci; forestomach: irregular surface) and thymus (reddish discolouration) were found in both animals that died during the study. Additionally, in one of these animals gelatinous contents of the gastro intestinal-tract were found.
Furthermore, advanced autolysis was seen in both animals found dead. This finding was considered to be due to the time elapsed between death and macroscopic examination.
At 300 mg/kg, no abnormalities were found at macroscopic examination of the animals. - Other findings:
- According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 1000 mg/kg body weight.
Any other information on results incl. tables
Table 1: Body Weight Data (g)
Dose Group |
Animal Number |
Day 1 |
Day 8 |
Day 15 |
Group dosed with 2000 mg/kg bw |
1 |
147* |
- |
- |
2 |
162 |
183 |
202 |
|
3 |
164** |
- |
- |
|
Mean (SD) |
158 (9) |
183 |
202 |
|
First group dosed with 300 mg/kg bw |
4 |
153 |
178 |
206 |
5 |
153 |
190 |
197 |
|
6 |
155 |
191 |
206 |
|
Mean (SD) |
154 (1) |
186 (7) |
203 (5) |
|
Second group dosed with 300 mg/kg bw |
7 |
169 |
203 |
213 |
8 |
159 |
187 |
198 |
|
9 |
161 |
180 |
194 |
|
Mean (SD) |
163 (5) |
190 (12) |
202 (10) |
*Animal found dead on day 2. Body weight at death 139 g
**Animal found dead on day 2. Body weight at death 160 g
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the LD50 value was established to be within the range of 300 to 2000 mg/kg body weight and in accordance with OECD Guideline 423, the LD50 cut-off value was considered to be 1000 mg/kg.
- Executive summary:
The potential of the test material to cause acute oral toxicity in the rat was investigated in accordance with the standardised guidelines OECD 423, EU Method B.1 tris, EPA OPPTS 870.1100 and JMAFF 12 Nousan, Notification No 8147 under GLP conditions.
Initially, the test material was administered by oral gavage to three female Wistar rats at 2000 mg/kg body weight. In a stepwise procedure, two additional groups of three females were dosed at 300 mg/kg body weight. All animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or after terminal sacrifice (Day 15).
At 2000 mg/kg, two animals were found dead on day 2. At 300 mg/kg, no mortality occurred.
At 2000 mg/kg, hunched posture, piloerection and/or diarrhoea were noted for the animals on Day 1. At 300 mg/kg, hunched posture, piloerection and/or diarrhoea were noted for the animals on Days 1 and 2.
The body weight gain shown by the surviving animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.
At 2000 mg/kg, abnormalities of the stomach (glandular mucosa: several dark red foci; forestomach: irregular surface) and thymus (reddish discolouration) were found in both animals that died during the study, at macroscopic post mortem examination. Additionally, in one of these animals gelatinous contents of the gastro intestinal-tract were found. At 300 mg/kg, no abnormalities were found at macroscopic examination of the animals.
Under the conditions of this study the LD50 value was established to be within the range of 300 to 2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 1000 mg/kg body weight.
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