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EC number: 220-836-1 | CAS number: 2915-57-3
- 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
Studies were conducted according to recognised testing guidelines and with GLP certification.
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:
- 26 November 2012 to 13 December 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HsdHan:WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 167 - 179 g (on day of dosing)
- Fasting period before study: animals were fasted from the evening of the day prior to dosing (day -1) until approximately 3 hours after dosing
- Housing: animimals were housed in groups up to 5 during the acclimation period and in groups of three from the day prior to dosing. Cages conformed to the Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Ofice, London, 1989)
- Diet: ad libitum
- Water: mains water, ad libitum
- Acclimation period: 7 - 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 32 - 71 %
- Air changes (per hr): 15 - 20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- TEST MATERIAL FORMULATION
The test material was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.
Individual doses were calculated using the fasted body weights of the rats on the morning of dosing and the specific gravity of the neat test material. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 females per treatment group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: animals were observed for clinical signs of reaction to treatment 15 and 30 minutes and 1, 2, 3 and 4 hours post-dose on day 1, twice daily on days 2, 3 and 4 and once daily thereafter.
- Frequency of weighing: animals were weighed on the day prior to dosing and on days 1, 4, 8 and 15
- Necropsy of survivors performed: yes. A full macroscopic examination was performed and all lesions recorded. The necropsy procedure included inspection of the external surfaces and orifices, all viscera and tissue within the abdominal, thoracic and cranial cavities, free-hand sectioning of the liver and kidneys and examination of representative sections of mucosal surfaces of the stomach, small and large intestines. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died during the study.
- Clinical signs:
- other: Clinical signs were confined to decreased activity and hunched posture in three animals two hours after dosing. These signs persisted in two animals three hours after dosing.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study the acute oral LD50 of the test material was determined to be in excess of 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the test material was determined in a GLP study which was conducted in line with standardised guidelines OECD 423 and EU Method B.1 tris. During the study, two groups of three female rats were dosed test material, by gavage, at a dose level of 2000 mg/kg. Following administration, animals were observed for mortality and clinical signs, and body weights were recorded, over a period of 14 days. All animals were sacrificed on day 15 and underwent a full necropsy. None of the animals died during the study and clinical signs were confined to decreased activity and hunched posture in three animals two hours after dosing. These signs persisted in two animals three hours after dosing. All rats achieved body weight gains during the first and second weeks of the study and no abnormalities were noted at necropsy. Under the conditions of the study the acute oral LD50 of the test material was determined to be in excess of 2000 mg/kg bw.
Reference
Table 1: Individual Body Weights
Animal number |
Body weight (g) |
||||
day -1 |
day 1 |
day 4 |
day 8 |
day15 |
|
184 |
187 |
172 |
187 |
189 |
197 |
185 |
188 |
179 |
193 |
198 |
200 |
186 |
174 |
168 |
181 |
186 |
192 |
187 |
182 |
174 |
182 |
190 |
203 |
188 |
174 |
167 |
173 |
181 |
191 |
189 |
174 |
167 |
173 |
180 |
190 |
Table 2: Clinical Signs Following Treatment
Animals number |
Clinical sign |
Sign noted after dosing on day 1 (hours): |
Sign noted on day 2 - 15 |
||
1 |
2 |
3 |
|||
187 |
decrease activity |
X |
X |
||
hunched posture |
X |
X |
|||
188 |
decrease activity |
X |
X |
||
hunched posture |
X |
X |
|||
189 |
decrease activity |
X |
|||
hunched posture |
X |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The study was performed in line with GLP and accepted standardised guidelines with a high standard of reporting. The study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the substance.
Acute toxicity: via inhalation route
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:
- 4 December 2012 to 27 December 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- The relative humidity reached maximum value of 71 %
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- The relative humidity reached maximum value of 71 %
- Principles of method if other than guideline:
- The relative humidity reached maximum value of 71 %, 1 % higher than the maximum recommended in the guidelines. This deviations was not considered not to have affected the integrity or outcome of the study.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HsdHan:WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 236 - 302 g (males); 173 - 202 g (females)
- Housing: in groups up to 5 by sex during acclimation and individually from the day prior to dosing. After completion of the day 3 observations animals allocated to the main study were returned to group housing. Cages conformed to the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989)
- Diet: ad libitum
- Water: mains warer, ad libitum
- Acclimation period: 8 to 16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 45 - 71 %
- Air changes (per hr): 15 - 20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
Hair from the dorsum was removed with electric clipper on the day before dosing. the dermal site was an area of at least 10 % of the total body surface. The test material was spread evenly across the dermal test site. A dense gauze patch was placed over the treated skin, held in places with and elasticated, open-weave, adhesive compression bandage. this was wrapped securely around the torso of the animal.
REMOVAL OF TEST SUBSTANCE
The dressing was removed approximately 24 hours after application. The dermal test site of each rat was lightly brushed clean of any solid residues and swabbed with water-moistened cotton wool before the animal was returned to the holding cage.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): individual dose volumes were calculated from the body weights of the rats on the morning of dosing (day 1), taking account of the specific gravity of the test material (0.914 g/mL). The dose volume applied to each animal was 2.19 mL/kg (dose level: 2000 mg/kg bw). - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 males and 5 females per group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: clinical signs were recorded immediately post-dose and approximately 15 and 30 minutes, and 1, 2, 3 and 4 hours post-dose on day 1, twice daily on days 2, 3 and 4 and daily thereafter.
- Frequency of weighing: animals were weighed on days -1, 1, 4, 8 and 15
Necropsy of survivors performed: yes. A full macroscopic examination was performed and all lesions recorded. The necropsy procedure included inspection of the external surfaces and orifices, all viscera and tissue within the abdominal, thoracic and cranial cavities, free-hand sectioning of the liver and kidneys and examination of representative sections of mucosal surfaces of the stomach, small and large intestines.
- Other examinations performed: dermal reactions. The condition of the dermal test site was recorded following removal of the dressing on day 2 and once daily thereafter. erythema and oedema were scored according to the Draize scale (Table 1). - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mL/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died during the study.
- Clinical signs:
- other: There were no clinical signs of reaction to treatment.
- Gross pathology:
- No macroscopic changes were noted at necropsy.
- Other findings:
- There were no dermal reactions.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, the acute dermal median lethal dose of the test material was estimated to be in excess of 2000 mg/kg to male and female rats.
- Executive summary:
The acute dermal toxicity of the test material was determined in a GLP study which was conducted in accordance with standardised guidelines OECD 402 and EU Method B.3. During the study five male and female rats received a single dermal application of 2000 mg/kg of the test material and were assessed daily for the following 14 days for any signs of systemic toxicity. None of the animals died and there were no signs of systemic toxicity. There were no dermal reactions and all animals gained weight during the study. There were no macroscopic abnormalities at examination post mortem. The acute dermal median lethal dose of the test material was estimated to be in excess of 2000 mg/kg to both male and female rats.
Reference
Table 2: Individual body weights and weekly increments
Dose level (mg/kg) |
Animal number and sex |
Body weight (g) at: |
Increment (g) |
|||||
Day -1 |
Day 1 |
Day 4 |
Day 8 |
Day 15 |
Day 1 to 8 |
Day 8 to 15 |
||
2000 |
194M |
231 |
236 |
241 |
259 |
270 |
23 |
11 |
195M |
267 |
271 |
271 |
280 |
301 |
9 |
21 |
|
196M |
297 |
302 |
295 |
312 |
324 |
10 |
12 |
|
197M |
261 |
268 |
266 |
274 |
297 |
6 |
23 |
|
198M |
288 |
296 |
292 |
310 |
332 |
14 |
22 |
|
2000 |
203F |
183 |
183 |
189 |
194 |
202 |
11 |
8 |
204F |
189 |
194 |
191 |
198 |
205 |
4 |
7 |
|
205F |
198 |
202 |
196 |
207 |
218 |
5 |
11 |
|
206F |
185 |
189 |
183 |
189 |
203 |
0 |
14 |
|
207F |
180 |
173 |
175 |
183 |
195 |
10 |
12 |
Table 3: Dermal Reactions - Males
Day |
Dermal reaction |
Animal number and sex |
||||
194M |
195M |
196M |
197M |
198M |
||
2 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
3 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
4 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
5 to 15 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Dermal Reactions - Females
Day |
Dermal reaction |
Animal number and sex |
||||
203F |
204F |
205F |
206F |
207F |
||
2 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
3 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
4 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
5 to 15 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The study was performed in line with GLP and accepted standardised guidelines with a high standard of reporting. The study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the substance.
Additional information
Oral
The acute oral toxicity of the test material was determined in a GLP study which was conducted in line with standardised guidelines OECD 423 and EU Method B.1 tris. During the study, two groups of three female rats were dosed test material, by gavage, at a dose level of 2000 mg/kg. Following administration, animals were observed for mortality and clinical signs, and body weights were recorded, over a period of 14 days. All animals were sacrificed on day 15 and underwent a full necropsy. None of the animals died during the study and clinical signs were confined to decreased activity and hunched posture in three animals two hours after dosing. These signs persisted in two animals three hours after dosing. All rats achieved body weight gains during the first and second weeks of the study and no abnormalities were noted at necropsy. Under the conditions of the study the acute oral LD50 of the test material was determined to be in excess of 2000 mg/kg bw.
Inhalation
According to point 8.5 of Annex VIII of Regulation (EC) No. 1907/2006, the test for the second acute toxicity study will be performed on the most appropriate route of exposure, taking into account the nature of the substance and the likely route of human exposure. The test substance has very low vapour pressure, so the potential for the generation of inhalable forms is low. Furthermore, the use of this substance will not result in aerosols, particles or droplets of an inhalable size being formed, therefore exposure to humans via the inhalation route will be unlikely to occur. On these bases, no acute inhalation toxicity test was performed.
Dermal
The acute dermal toxicity of the test material was determined in a GLP study which was conducted in accordance with standardised guidelines OECD 402 and EU Method B.3. During the study five male and female rats received a single dermal application of 2000 mg/kg of the test material and were assessed daily for the following 14 days for any signs of systemic toxicity. None of the animals died and there were no signs of systemic toxicity. There were no dermal reactions and all animals gained weight during the study. There were no macroscopic abnormalities at examination post mortem. The acute dermal median lethal dose of the test material was estimated to be in excess of 2000 mg/kg to both male and female rats.
Justification for selection of acute toxicity – oral endpoint
Only one study is available.
Justification for selection of acute toxicity – dermal endpoint
Only one study is available.
Justification for classification or non-classification
In accordance with with criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the test material does not require classification for acute oral, or acute dermal, toxicity as no signs of toxicity were noted during the course of ether of the studies.
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