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EC number: 203-828-2 | CAS number: 111-05-7
- 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
Endpoint summary
Administrative data
Description of key information
Two acute oral and dermal toxicity studies are available (OECD 423 and OECD 402).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 November 2012 - 24 January 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guidelines; adequate consistence between data, comments and conclusions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: approximately 8 weeks old on the day of treatment
- Mean body weight at study initiation: 201 g (range: 191 g to 208 g)
- Fasting period before study: yes, during the night before treatment
- Housing: the animals were housed by three from the same group in polycarbonate cages with stainless steel lids (Techniplast 2154, 940 cm2)
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h.
IN-LIFE DATES: 04 December 2012 to 26 December 2012. - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/kg
- Maximum dose-volume applied: 10 mL/kg.
DOSAGE PREPARATION (if unusual): The test item was administered as a homogenous suspension in the vehicle. Although the test item was a wax, it was ground to a fine powder, using a mortar and pestle, and then mixed with the required quantity of vehicle.
Dose formulations preparations were prepared by the CiToxLAB France Pharmacy extemporaneously on the day of each administration.
The dose formulations were stored at room temperature and delivered to the study room in brown flasks.
CLASS METHOD (if applicable):
- Rationale for the selection of the starting dose: The starting dose-level was selected in agreement with the Sponsor, based on available test item toxicity data, no morbidity or mortality was expected to occur at the dose level of 2000 mg/kg. This was therefore chosen as the starting dose-level.
After treatment at the starting dose-level, the next dose-level was administered in a sequential manner, under the same conditions to different animals, based on the dose-levels indicated in the flow charts of OECD Guideline No. 423, 17th December 2001, which are equivalent to those of Commission Regulation (EC) No. 440/2008, B.1tris (30 May 2008).
Based on the results obtained for groups 1 and 2, a third group was not tested. - Doses:
- 2000 mg/kg.
- No. of animals per sex per dose:
- 3 females per treatment step.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then once a day.
- Body weight: just before treatment on day 1; then on days 8 and 15.
- Necropsy of survivors performed: yes (macroscopic). - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No unscheduled deaths occurred during the study.
- Clinical signs:
- other: No clinical signs were observed in any animals.
- Gross pathology:
- There were no macroscopic post-mortem observations.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP Regulation
- Conclusions:
- The oral LD50 of the test item was higher than 2000 mg/kg in rats.
Therefore, the test item should not be classified as toxic by oral route according to the criteria of CLP Regulation. - Executive summary:
The objective of this study was to evaluate the potential acute toxicity of the test item following a single oral administration (gavage) to rats.
Methods
The test item was administered once by oral route (gavage) to two groups of three fasted female Sprague-Dawley rats under a dosage-volume of 10 mL/kg. The test item was prepared in corn oil.
Based on available test item toxicity data, the starting dose-level of 2000 mg/kg was chosen. After the first assay, as no toxicity was observed, the results were confirmed in three other females.
Each animal was observed at least once a day for mortality and clinical signs for 15 days. Body weight was recorded on the day of allocation of the animals into groups, then on days 1, 8 and 15.
On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination. No tissues were preserved.
Results
No unscheduled deaths occurred during the study and no clinical signs were observed in any animals.
When compared to CiToxLAB France historical control data and taking into account the initial body weight values, a lower body weight gain was noted in 1/6 females between days 1 and 8 and in 2/6 females between days 8 and 15. In addition, an overall lower body weight gain was observed in 1/6 females between days 1 and 15. The test item had no effect on the body weight evolution, as these lower body weight gains were considered to be minimal and of fortuitous occurrence.
There were no macroscopic post-mortem observations.
Conclusion
The oral LD50of the test item was higher than 2000 mg/kg in rats.
Therefore, the test item should not be classified as toxic by oral route according to the criteria of CLP Regulation.
Reference
see Executive summary
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP study
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 February 2013 - 22 March 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guidelines
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: approximately 8 weeks old on the day of treatment
- Mean body weight at study initiation: for the males 351 g (range: 345 g to 357 g) and the females 225 g (range: 218 g to 231 g).
- Housing: the animals were housed by five from the same sex and group in polycarbonate cages.
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: the animals were acclimated to the study conditions for a period of 5 days (females) or 8 days (males) before treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h.
IN-LIFE DATES: 26 February 2013 to 15 March 2013 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10% of body surface, dorsal site
- Type of wrap if used: hydrophilic gauze pad + adhesive hypoallergenic aerated semi-occlusive dressing + restraining bandage
REMOVAL OF TEST SUBSTANCE
- Removal of dressing: 24h post-exposure
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ----
- Constant volume: no
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight: just before treatment on day 1; then on days 8 and 15.
- Necropsy of survivors performed: yes (macroscopic). - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No unscheduled deaths occurred during the study.
- Clinical signs:
- other: No clinical signs indicative of systemic toxicity were observed in any animals. In females: Moderate to severe erythemas were noted at the application site in 3/5 females on day 2. Then, well defined erythemas were observed in 5/5 females from day 2 or
- Gross pathology:
- There were no test item treatment-related macroscopic findings.
The few macroscopic finding were those commonly observed in this species and strain. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 of the test item was higher than 2000 mg/kg in rats
- Executive summary:
The objective of this study was to evaluate the potential toxicity of the test item following a single dermal application to rats.
Methods
The test item was applied in its original form to the skin of five female then five male Sprague‑Dawley rats at the dose-level of 2000 mg/kg. The application site was covered by a semi‑occlusive dressing for 24 hours.
Each animal was observed at least once a day for mortality and clinical signs for 15 days. From day 2, any local reactions at the treatment site were also noted. Body weight was recorded on day 1 and then on days 8 and 15.
On completion of the observation period, the animals were sacrificed and then submitted for a macroscopicpost-mortemexamination. Macroscopic lesions were preserved in buffered formalin then destroyed at the finalization of the study reportas no microscopic examination was performed.
Results
No unscheduled deaths occurred during the study and no clinical signs indicative of systemic toxicity were observed in any animals.
In fermales, moderate to severe erythemas were noted at the application site in 3/5 females on day 2. Then, well‑defined erythemas were observed in 5/5 females from day 2 or 3 until day 5, which turned into very slight erythemas from day 6 until day slight dryness of the skin was noted at the application site in 5/5 females from day 3 until day 6 or 7.
In males, well-defined or very slight erythemas were noted at the application site of all males, from day 2 up to day 6.
When compared toCiToxLAB Francehistorical control data, a lower mean body weight gain was noted in males between day 1 and day 8. Mean body weight gain returned to normal values thereafter.
There were no test item treatment-related macroscopic findings.
Conclusion
The dermal LD50of the test item was higher than 2000 mg/kg in rats.
Therefore, the test item is not classified as toxic by dermal route according to the criteria of CLP Regulation.
Reference
Sex |
Female |
Male |
||
Group |
CiToxLAB France historical control data |
1 |
CiToxLABFrancehistorical control data |
2 |
Dose-level (mg/kg) |
0 |
2000 |
0 |
2000 |
Body weight (mean (± SD)) |
|
|
|
|
. Day 1 |
236 (± 8.9) |
225 (± 6.4) |
332 (± 6.6) |
351 (± 4.6) |
. Day 8 |
253 (± 12.0) |
250 (± 4.6) |
377 (± 7.4) |
382 (± 8.1) |
. Day 15 |
273 (± 16.3) |
269 (± 11.5) |
422 (± 11.3) |
430 (± 8.0) |
Body weight change (mean (± SD)) |
|
|
|
|
. Days 1-8 |
+17 (± 11.0) |
+25 (± 7.1) |
+45 (± 4.0) |
+31 (± 6.4) |
. Days 8-15 |
+20 (± 7.1) |
+19 (± 8.1) |
+45 (± 6.2) |
+48 (± 2.0) |
. Days 1-15 |
+37 (± 16.3) |
+44 (± 12.0) |
+90 (± 8.2) |
+78 (± 6.8) |
SD: standard deviations.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP study
Additional information
Justification for classification or non-classification
The registered substance is not classified for acute toxicity hazard
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