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EC number: 931-468-2 | CAS number: 1190625-94-5
- 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
ACUTE ORAL
LD50 > 2000 mg/kg bw (rat); OECD 423, EU Method B.1 tris, EPA OPPTS 870.1100 and JMAFF 12 Nousan, Notification No. 8147
ACUTE DERMAL
LD50 > 2000 mg/kg bw (rat); OECD 402, EU Method B.3, EPA OPPTS 870.1200 and JMAFF 12 Nousan, Notification No. 8147
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:
- 08 August 2014 to 02 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.
- 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
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- 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 weeks old
- Weight at study initiation: 147 to 163 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 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.215 mL/kg body weight. Dose volume was calculated as dose level (g/kg) / density (g/mL).
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females; the test material was administered to two subsequent groups of three female rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and viability twice daily. Body weights were recorded on Day 1 (pre-administration of the test material) and on Days 8 and 15. 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.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Hunched posture and piloerection were noted for all animals between Days 1 and 3.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the LD50 value was found to exceed 2000 mg/kg bw.
- 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.
The test material was administered by oral gavage to two subsequent groups of three fasted female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was conducted after terminal sacrifice (Day 15).
No mortality occurred. Hunched posture and piloerection were noted for all animals between Days 1 and 3. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.
Under the conditions of this study the LD50 value was found to exceed 2000 mg/kg bw.
Reference
Table 1: Body Weight Data (g)
Dose Group |
Animal Number |
Day 1 |
Day 8 |
Day 15 |
First group dosed with 2000 mg/kg bw |
1 |
154 |
178 |
181 |
2 |
163 |
188 |
198 |
|
3 |
157 |
182 |
196 |
|
Mean (SD) |
158 (5) |
183 (5) |
192 (9) |
|
Second group dosed with 2000 mg/kg bw |
4 |
148 |
182 |
198 |
5 |
153 |
186 |
196 |
|
6 |
147 |
180 |
194 |
|
Mean (SD) |
149 (3) |
183 (3) |
196 (2) |
SD = Standard deviation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study was conducted in accordance with standardised guidelines and under GLP conditions. The study was awarded a reliability score of 1 in accordance with the principles for assessing data quality set forth by Klimisch et al. (1997). The quality of the database is therefore considered to be high.
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:
- 21 January 2015 to 04 February 2015
- 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.
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 12 Nousan, Notification No 8147
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/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 10 weeks old
- Weight at study initiation: Males 259 to 285 g; females 187 to 205 g. Body weight variation did not exceed ± 20 % of the sex mean.
- Fasting period before study: No
- Housing: During acclimatisation, animals were group housed (cage height 18 cm). During the study, animals were individually housed 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 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: One day before exposure (Day -1) an area of approximately 5 x 7 cm on the back of each animal was clipped.
- % coverage: The test material was applied on an area of approx. 10 % of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females.
- Type of wrap if used: The test material was held in contact with the skin with a dressing, consisting of a surgical gauze patch, successively covered with aluminium foil and elastic bandage. A piece of tape was additionally used for fixation of the bandages in females only.
REMOVAL OF TEST MATERIAL
- Washing (if done): Dressings were removed and the skin cleaned of residual test material using tap water.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: 2.215 mL/kg body weight. Dose volume calculated as dose level (g/kg) / density (g/mL).
- Other: The test material was stirred on a magnetic stirrer during application. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and viability twice daily. Body weights were recorded on Day 1 (pre-administration of the test material) and on Days 8 and 15. 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. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Lethargy, flat posture, piloerection, shallow respiration, chromodacryorrhoea (snout) and/or ptosis were noted for the animals between Days 1 and 3. Additionally, hunched posture was noted for the animals between Days 1 and 15. General erythema, erythema
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the LD50 value was found to exceed 2000 mg/kg bw.
- Executive summary:
The potential of the test material to cause acute dermal toxicity in the rat was investigated in accordance with the standardised guidelines OECD 402, EU Method B.3, EPA OPPTS 870.1200 and JMAFF 12 Nousan, Notification No. 8147 under GLP conditions.
The test material was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. After the exposure period, dressings were removed and the skin cleaned of residual test material using tap water. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred. Lethargy, flat posture, piloerection, shallow respiration, chromodacryorrhoea (snout) and/or ptosis were noted for the animals between Days 1 and 3. Additionally, hunched posture was noted for the animals between Days 1 and 15.
General erythema, erythema maculate, scales, scabs, wounds and/or thickened areas were seen in the treated skin, abdomen and/or flanks of the animals during the observation period.
The mean body weight gain during the observation period was within the range expected for rats used in this type of study.
No abnormalities were found at macroscopic post mortem examination of the animals.
Under the conditions of this study the LD50 value was found to exceed 2000 mg/kg bw.
Reference
Table 1: Body Weight Data (g)
Dose Group |
Animal Number |
Day 1 |
Day 8 |
Day 15 |
Males dosed with 2000 mg/kg bw |
1 |
264 |
267 |
273 |
2 |
285 |
286 |
313 |
|
3 |
272 |
284 |
311 |
|
4 |
284 |
280 |
308 |
|
5 |
259 |
267 |
292 |
|
Mean (SD) |
273 (12) |
277 (9) |
299 (17) |
|
Females dosed with 2000 mg/kg bw |
6 |
191 |
185 |
204 |
7 |
205 |
204 |
203 |
|
8 |
191 |
194 |
205 |
|
9 |
201 |
194 |
198 |
|
10 |
187 |
188 |
192 |
|
Mean (SD) |
195 (8) |
193 (7) |
200 (5) |
SD = Standard deviation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study was conducted in accordance with standardised guidelines and under GLP conditions. The study was awarded a reliability score of 1 in accordance with the principles for assessing data quality set forth by Klimisch et al. (1997). The quality of the database is therefore considered to be high.
Additional information
Acute Oral Toxicity
In the key study, 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.
The test material was administered by oral gavage to two subsequent groups of three fasted female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was conducted after terminal sacrifice (Day 15).
No mortality occurred. Hunched posture and piloerection were noted for all animals between Days 1 and 3. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.
Under the conditions of this study the LD50 value was found to exceed 2000 mg/kg bw.
Acute Inhalation Toxicity
In accordance with Section 8.5.2. of Column 2 of Annex VIII of the REACH Regulation, the registrant proposes to waive the acute toxicity testing by the inhalation route on the grounds that exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and the possibility of exposure to aerosols, particles or droplets of an inhalable size.
Acute Dermal Toxicity
In the key study, the potential of the test material to cause acute dermal toxicity in the rat was investigated in accordance with the standardised guidelines OECD 402, EU Method B.3, EPA OPPTS 870.1200 and JMAFF 12 Nousan, Notification No. 8147 under GLP conditions.
The test material was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. After the exposure period, dressings were removed and the skin cleaned of residual test material using tap water. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred. Lethargy, flat posture, piloerection, shallow respiration, chromodacryorrhoea (snout) and/or ptosis were noted for the animals between Days 1 and 3. Additionally, hunched posture was noted for the animals between Days 1 and 15.
General erythema, erythema maculate, scales, scabs, wounds and/or thickened areas were seen in the treated skin, abdomen and/or flanks of the animals during the observation period.
The mean body weight gain during the observation period was within the range expected for rats used in this type of study.
No abnormalities were found at macroscopic post mortem examination of the animals.
Under the conditions of this study the LD50 value was found to exceed 2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
Only one study available.
Justification for selection of acute toxicity – dermal endpoint
Only one study available.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to acute toxicity.
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