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EC number: 916-533-5 | 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
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- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
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- Additional physico-chemical information
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- Endpoint summary
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- 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
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- 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
Oral: LD50 > 2000 mg/kg bw (limit tes), OECD 423, EU Method B.1 tris, Kiss (2012).
Dermal: LD50 > 2000 mg/kg bw (limit test), OECD 402, EU Method B.3, EPA OPPTS 870.1200, JMAFF 2-1-2, Zelenák (2011).
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 September 2011 to 12 October 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted 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. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
- 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:
- other: JMAFF 12 Nousan 8147 (2000)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CRL:(WI)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9 weeks old.
- Weight at study initiation: 238 – 265 g.
- Fasting period before study: Yes, animals were fasted the day before dosing, food being returned 3 hours after treatment.
- Housing: Animals were housed in groups of 3 in Type II polypropylene/polycarbonate cages.
- Diet: Complete feed for rats and mice, ad libitum.
- Water: Municipal tap water, ad libitum.
- Acclimation period: At least 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15-20 air exchanges/hour.
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 06:00 to 18:00 hours. - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- DOSAGE PREPARATION: Test material was freshly formulated at a concentration of 200 mg/mL in the vehicle on the day of administration. The formulation container was stirred continuously up to finishing the treatment.
CLASS METHOD
- Rationale for the selection of the starting dose: The initial dose level was selected by the study director to be that which was most likely to produce mortality in some of the dosed animals.
ADMINISTRATION: Group 1 was dosed first at 2000 mg/kg bw . The results were then confirmed by dosing Group 2 in the same manner. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Six females per dose, tested in two groups of 3 animals.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
> Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and then daily until day 14. Observations included assessment of the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
> Bodyweights were measured on Days -1, 0, 7 and 14 prior to necropsy.
- Necropsy of survivors performed: yes
- Other examinations performed: After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed. Macroscopic abnormalities were recorded. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in either Group 1 or 2.
- Clinical signs:
- other: Liquid faeces was observed in all animals, treated at a dose level of 2000 mg/kg bw, on the day of dosing. All animals fully recovered and were symptom free from 6 hours after the treatment until the end of the observation period.
- Gross pathology:
- There was no evidence of treatment related findings at necropsy. Pelvic dilatation of the right kidney was incidentally observed in one animal.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, no signs of acute toxicity were observed, and it can be concluded that the acute oral LD50 is greater than 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the test material was assessed in study performed under GLP conditions and in line with OECD 423 and EU Method B.1 tris according to the acute toxic class method. Female CRL:(WI) rats were treated with the test material at a dose level of 2000 mg/kg bw in two groups. Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level.
Under the conditions of the study no mortality was observed in either group. Animals showed normal weight gain. Liquid faeces were observed in all animals on the day of dosing; all animals had fully recovered, and were symptom free, from 6 hours after the treatment until the end of the observation period. There was no evidence of treatment related findings at necropsy. Pelvic dilatation of the right kidney was incidentally observed in one animal. It can therefore be concluded that the acute oral LD50 of the test material is in excess of 2000 mg/kg bw.
Reference
Table1: Clinical Observations
Group |
Animal No. |
Observations |
Observation Days |
Frequency |
||||||
0 |
1 - 14 |
|||||||||
30 min |
1 h |
2 hrs |
3 hrs |
4 hrs |
6 hrs |
|||||
1 |
8861 |
Symptom Free |
+ |
+ |
+ |
- |
+ |
+ |
+ |
19/20 |
Faeces liquid |
- |
- |
- |
1 |
- |
- |
- |
1/20 |
||
8862 |
Symptom Free |
+ |
+ |
+ |
- |
+ |
+ |
+ |
19/20 |
|
Faeces liquid |
- |
- |
- |
1 |
- |
- |
- |
1/20 |
||
8863 |
Symptom Free |
+ |
+ |
+ |
- |
- |
+ |
+ |
18/20 |
|
Faeces liquid |
- |
- |
- |
1 |
1 |
- |
- |
2/20 |
||
2 |
8864 |
Symptom Free |
+ |
+ |
+ |
- |
+ |
+ |
+ |
19/20 |
Faeces liquid |
- |
- |
- |
1 |
- |
- |
- |
1/20 |
||
8865 |
Symptom Free |
+ |
+ |
+ |
- |
+ |
+ |
+ |
19/20 |
|
Faeces liquid |
- |
- |
- |
1 |
- |
- |
- |
1/20 |
||
8866 |
Symptom Free |
+ |
+ |
+ |
- |
+ |
+ |
+ |
19/20 |
|
Faeces liquid |
- |
- |
- |
1 |
- |
- |
- |
1/20 |
Frequency of observations = number of occurrence of observations / total number of observations.
Table 2: Bodyweights (g)
Group No. |
Animal No. |
Body weight (g) on Days |
Weight Gain (g) |
||||||
-1 |
0 |
7 |
14 |
-1 - 0 |
0 - 7 |
7 -14 |
-1 - 14 |
||
1 |
8861 |
281 |
265 |
296 |
301 |
-16 |
31 |
5 |
20 |
8862 |
273 |
256 |
288 |
296 |
-17 |
32 |
8 |
23 |
|
8863 |
269 |
251 |
290 |
304 |
-18 |
39 |
14 |
35 |
|
2 |
8864 |
266 |
249 |
281 |
290 |
-17 |
32 |
9 |
24 |
8865 |
257 |
239 |
267 |
277 |
-18 |
28 |
10 |
20 |
|
8866 |
255 |
238 |
257 |
274 |
-17 |
19 |
17 |
19 |
|
Mean: |
266.8 |
249.7 |
279.8 |
290.3 |
-17.2 |
30.2 |
10.5 |
23.5 |
|
Standard Deviation: |
9.8 |
10.3 |
15.0 |
12.5 |
0.8 |
6.6 |
4.3 |
6.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The quality of the dataset is 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:
- 19 October 2011 to 02 November 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted 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. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
- 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 2-1-2
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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
- Age at study initiation: Young adults.
- Weight at study initiation: 227 - 254 g.
- Housing: Individually in polypropylene/polycarbonate cages.
- Diet: Complete feed for rats and mice, ad libitum.
- Water: Municipal tap water, ad libitum.
- Acclimation period: 6 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15-20 air charges per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light, from 06:00 to 18:0 hours.
IN-LIFE DATES: From: 19 October 2011 To: 02 November 2011 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The back of each animal.
- % coverage: The test material was applied to the shaved skin. the test material was moistened with water and distributed as evenly as possible over an area of approximately 10 % of the total body area.
- Type of wrap if used: A gauze pad was placed over the applied test material. The gauze pad was fixed with a hypoallergenic plaster on the skin of the animals. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap.
REMOVAL OF TEST SUBSTANCE
- Washing: After exposure the treated area of skin was washed with water at body temperature.
- Time after start of exposure: 24 hours. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 per sex per dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
> Clinical Observations: Performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, the respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
> Bodyweights: Measured prior to dosing on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: Yes. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All macroscopic changes 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: No clinical signs were observed after the treatment with the test material or during the 14-day observation period. No local signs were observed after the treatment with the test material or during the 14-day observation period.
- Gross pathology:
- There was no evidence of the observations at a dose level of 2000 mg/kg bw at necropsy.
- Other findings:
- No local dermal signs were observed after treatment with the test material.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, no signs of systemic or local toxic effects were observed during the 14 day observation period. The acute dermal LD50 of the test material was determined to be greater than 2000 mg/kg bw in both male and female rats.
- Executive summary:
The acute dermal toxicity of the test material was assessed in study performed under GLP conditions and in line with OECD 402, EU Method B.3, EPA OPPTS 870.1200 and JMAFF 2-1-2. A limit test was carried out at 2000 mg/kg bw in both sexes (5 rats/sex). The test material was applied as supplied, moistened with water, as a single dermal 24-hour exposure followed by a 14-day observation period. After the exposure period the residual test material was removed by washing the area with water. Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Rats were euthanized and a gross macroscopic examination performed at the end of the 2-week observation period (Day 14).
Under the conditions of the study no mortality was observed at 2000 mg/kg bw. Bodyweights showed normal weight gain. No clinical signs of systemic or local toxic effects were observed during the 14 day observation period. Additionally there was no evidence of treatment related findings at necropsy. Accordingly the acute dermal LD50 of the test material was determined to be in excess of 2000 mg/kg bw.
Reference
Table 1: Male Bodyweight Data (g)
Animal No. |
Body weight (g) Days |
Body Weight Gain (g) |
||||
0 |
7 |
14 |
0-7 |
7-14 |
0-14 |
|
9407 |
243 |
297 |
340 |
54 |
43 |
97 |
9408 |
254 |
307 |
351 |
53 |
44 |
97 |
9409 |
245 |
299 |
348 |
54 |
49 |
103 |
9410 |
243 |
291 |
339 |
48 |
48 |
96 |
9411 |
237 |
289 |
340 |
52 |
51 |
103 |
Mean |
244.4 |
296.6 |
343.6 |
52.2 |
47.0 |
99.2 |
Standard Deviation |
6.1 |
7.1 |
5.5 |
2.5 |
3.4 |
3.5 |
Table 2: Female Bodyweight Data (g)
Animal No. |
Body weight (g) Days |
Body Weight Gain (g) |
||||
0 |
7 |
14 |
0-7 |
7-14 |
0-14 |
|
9412 |
229 |
240 |
252 |
11 |
12 |
23 |
9413 |
237 |
247 |
280 |
10 |
33 |
43 |
9414 |
227 |
238 |
252 |
11 |
14 |
25 |
9415 |
237 |
263 |
263 |
26 |
0 |
26 |
9416 |
245 |
257 |
269 |
12 |
12 |
24 |
Mean |
235.0 |
249.0 |
263.2 |
14.0 |
14.2 |
28.2 |
Standard Deviation |
7.2 |
10.8 |
11.9 |
6.7 |
11.9 |
8.3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The quality of the dataset is considered to be high.
Additional information
Oral Toxicity
In the key study (Kiss, 2011) the acute oral toxicity of the test material was assessed under GLP conditions and in line with OECD 423 and EU Method B.1 tris according to the acute toxic class method. Female CRL:(WI) rats were treated with the test material at a dose level of 2000 mg/kg bw in two groups. Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level.
Under the conditions of the study no mortality was observed in either group. Animals showed normal weight gain. Liquid faeces were observed in all animals on the day of dosing; all animals had fully recovered, and were symptom free, from 6 hours after the treatment until the end of the observation period. There was no evidence of treatment related findings at necropsy. Pelvic dilatation of the right kidney was incidentally observed in one animal. It can therefore be concluded that the acute oral LD50 of the test material is in excess of 2000 mg/kg bw.
Inhalation Toxicity
In accordance with point 8.5.2, Column 2 (Specific rules for adaptation from Column 1), Annex VIII of Regulation (EC) No. 1907/2006, an acute inhalation study does not need to be performed as the substance has a low vapour pressure (< 0.0015 Pa at 25 °C) and the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. The acute toxicity endpoint has been addressed by assessing toxicity via the oral and dermal routes, which are more appropriate when considering the properties of this substance.
Dermal Toxicity
In the key study (Zelenák, 2011) the acute dermal toxicity of the test material was assessed in study performed under GLP conditions and in line with OECD 402, EU Method B.3, EPA OPPTS 870.1200 and JMAFF 2-1-2. A limit test was carried out at 2000 mg/kg bw in both sexes (5 rats/sex). The test material was applied as supplied, moistened with water, as a single dermal 24-hour exposure followed by a 14-day observation period. After the exposure period the residual test material was removed by washing the area with water. Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Rats were euthanized and a gross macroscopic examination performed at the end of the 2-week observation period (Day 14).
Under the conditions of the study no mortality was observed at 2000 mg/kg bw. Bodyweights showed normal weight gain. No clinical signs of systemic or local toxic effects were observed during the 14 day observation period. Additionally there was no evidence of treatment related findings at necropsy. Accordingly the acute dermal LD50 of the test material was determined to be in excess of 2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
This study was performed under GLP conditions and in accordance with standardised guidelines. It was assigned a reliability score of 1 in accordance with the criteria outlined in Klimisch (1997). It was therefore considered suitable to be the key study for this endpoint.
Justification for selection of acute toxicity – inhalation endpoint
A data waiver has been submitted to address this endpoint.
Justification for selection of acute toxicity – dermal endpoint
This study was performed under GLP conditions and in accordance with standardised guidelines. It was assigned a reliability score of 1 in accordance with the criteria outlined in Klimisch (1997). It was therefore considered suitable to be the key study for this endpoint.
Justification for classification or non-classification
Acute Oral Toxicity:
According to the criteria outlined in Regulation (EC) No. 1272/2008, the test material does not meet the criteria for classification for acute oral toxicity.
Acute Dermal Toxicity:
According to the criteria outlined in Regulation (EC) No. 1272/2008, the test material does not meet the criteria for classification for acute dermal toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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