Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 915-656-1 | 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
Endpoint summary
Administrative data
Description of key information
Oral (Read-across from structurally similar substance)
LD50 > 2000 mg/kg bw, female rat, OECD 420, EU Method B.1 bis, Bradshaw (2009).
Dermal (Read-across from structurally similar substance)
LD50 > 2000 mg/kg bw, male/female rat, OECD 402, Zelenák (2013).
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:
- 20 January 2009 and 12 February 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with GLP and agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
- Remarks:
- Study conducted on read-across material
- Justification for type of information:
- A RAAF report will shortly be provided.
- Reason / purpose for cross-reference:
- other: Read-across target
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of Signature: 15/10/2007 Date of Inspection: 21/08/2007
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK.
- Age at study initiation: At the start of the study the animals were eight to twelve weeks of age.
- Weight at study initiation: The bodyweight variation did not exceed ± 20% of the initial/mean bodyweight of any previously dosed animal(s).
- Fasting period before study: Overnight fast immediately before dosing and for approximately three to four hours after dosing.
- Housing:The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum):Free access to food (2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water.
- Acclimation period: Acclimatisation period of at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature were set to achieve limits of 19 to 25°C.
- Humidity (%): Relative humidity were set to achieve limits 30 to 70%.
- Air changes (per hr): rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
IN-LIFE DATES: From:Day 0 To:Day 14 - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200mg/ml
- Amount of vehicle (if gavage):10ml/kg
- Justification for choice of vehicle:. Arachis oil BP was used because the test material did not dissolve/suspend in distilled water.
- Lot/batch no. (if required): Not available
- Purity: Not available
MAXIMUM DOSE VOLUME APPLIED: 10ml/kg
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test material, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg bodyweight. - Doses:
- A total of five animals were treated at a dose level of 2000 mg/kg in the study.
- No. of animals per sex per dose:
- Starting dose -1 female rat dose level-2000mg/kg
Additional group - 4 female rats dose level-2000mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Clinical observations were made ½, 1, 2, and 4 hours after dosing and subsequently once daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- None
- Preliminary study:
- There were no deaths.
No signs of systemic toxicity were noted.
No abnormalities were noted at necropsy. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted.
- Gross pathology:
- Individual necropsy findings are given in Table 3.
No abnormalities were noted at necropsy. - Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System - Unclassified).
- Executive summary:
Introduction. The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the following:
§ OECD Guidelines for Testing of Chemicals No 420 “Acute Oral Toxicity - Fixed Dose Method” (adopted)
§ Method B1bisAcute Toxicity (Oral) of Commission Directive 2004/73/EC
Method. Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test material, as asuspensioninarachis oil BP, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Mortality. There were no deaths.
Clinical Observations. There were no signs of systemic toxicity.
Bodyweight. All animals showed expected gains in bodyweight.
Necropsy. No abnormalities were noted at necropsy.
Conclusion. The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System-Unclassified).
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- A RAAF report will shortly be provided.
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
Referenceopen allclose all
Table1 Individual Clinical Observations and Mortality Data
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
1-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-1 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-3 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table2 Individual Bodyweights and Bodyweight Changes
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 Female |
208 |
219 |
223 |
11 |
4 |
2-0 Female |
171 |
184 |
193 |
13 |
9 |
|
2-1 Female |
183 |
187 |
194 |
4 |
7 |
|
2-2 Female |
186 |
199 |
209 |
13 |
10 |
|
2-3 Female |
184 |
197 |
211 |
13 |
14 |
Table3 Individual Necropsy Findings
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
2000 |
1-0 Female |
Killed Day 14 |
No abnormalities detected |
2-0 Female |
Killed Day 14 |
No abnormalities detected |
|
2-1 Female |
Killed Day 14 |
No abnormalities detected |
|
2-2 Female |
Killed Day 14 |
No abnormalities detected |
|
2-3 Female |
Killed Day 14 |
No abnormalities detected |
0= No signs of systemic toxicity
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The read-across study was performed in accordance with standardised guidelines and under GLP conditions and was assigned a reliability score of 1 in accordance with the criteria for assessing data quality as described in Klimisch et al. (1997). The quality of the database is therefore considered to be high.
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:
- other:
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:
- 30 January 2013 to 13 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with GLP and agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
- Remarks:
- Study conducted on read-across material
- Justification for type of information:
- A RAAF report will shortly be provided.
- Reason / purpose for cross-reference:
- other: Read-across target
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CRL:(WI) (SPF)
- 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: 219 to 248 g
- Housing: Individually in type II polypropylene/polycarbonate cages
- Diet: ad libitum
- Water: municipal tap water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 to 70 % (relative)
- Air changes: 15 to 20 air changes per hour
- Photoperiod: 12 hour light/dark cycle (light from 06:00 to 18:00)
IN-LIFE DATES:
From: 24 January 2013
To: 13 February 2013 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back. Animals were shaved 24 hours prior to exposure
- % coverage: Approximately 10 %
- Type of wrap if used: Sterile gauze pads held in place by a patch with an adhesive hypoallergenic plaster and the entire trunk of the animal wrapped in a semi-occlusive plastic wrap.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water (at body temperature)
- Time after start of exposure: 24 hours
TEST MATERIAL
- For solids, paste formed: Yes; the test material was moistened with water to ensure good contact with the skin - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on the day of treatment at 1 and 5 hours after application and once each day 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. Body weights were recorded on Day 0 (prior to test material administration), and on days 7 and 14.
- Necropsy of survivors performed: Yes. All animals were anaesthetised with RELEASE 300 mg/mL inj. A.U.V and exsanguinated. 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 during the study.
- Clinical signs:
- other: No clinical signs, including local dermal signs, were observed after treatment with the test material or during the 14-day observation period.
- Gross pathology:
- There was no evidence of any macroscopic changes at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute dermal median lethal dose (LD50) was determined to be > 2000 mg/kg bw in male and female rats.
- Executive summary:
The acute dermal toxicity of the test material was determined in male and female CRL:(WI) rats in accordance with the standardised guideline OECD 402 under GLP conditions.
The study was performed as a limit test. 2000 mg/kg bw was applied to the shaved back of 5 animals of each sex (equating to around 10 % of the surface area of the skin) and covered with a semi-occlusive dressing. After 24 hours, the test site was washed with water and the animals were observed for any reactions over a fourteen day observation period. Bodyweights were recorded at days 0, 7 and 14. At the end of the study, all surviving animals were submitted for necropsy.
There was no mortality throughout the study and none of the animals demonstrated any clinical signs of toxicity. Bodyweights and bodyweight gains were not affected by test material administration. All animals were found to be normal at necropsy.
Under the conditions of this study, the acute dermal median lethal dose (LD50) was determined to be > 2000 mg/kg bw in male and female rats.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- A RAAF report will shortly be provided.
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Referenceopen allclose all
Table 1: Bodyweight and Bodyweight Gain for Males
Animal No. |
Bodyweight (g) |
Bodyweight Gain (g) |
||||
Day 0 |
Day 7 |
Day 14 |
Days 0 to 7 |
Days 7 to 14 |
Days 0 to 14 |
|
9419 |
237 |
292 |
333 |
55 |
41 |
96 |
9420 |
248 |
292 |
334 |
44 |
42 |
86 |
9421 |
245 |
287 |
313 |
42 |
26 |
68 |
9422 |
234 |
281 |
329 |
47 |
48 |
95 |
9423 |
234 |
284 |
334 |
50 |
50 |
100 |
Mean |
239.6 |
287.2 |
328.6 |
47.6 |
41.4 |
89.0 |
Standard Deviation |
6.5 |
4.9 |
9.0 |
5.1 |
9.4 |
12.8 |
Table 2: Bodyweight and Bodyweight Gain for Females
Animal No. |
Bodyweight (g) |
Bodyweight Gain (g) |
||||
Day 0 |
Day 7 |
Day 14 |
Days 0 to 7 |
Days 7 to 14 |
Days 0 to 14 |
|
9424 |
230 |
252 |
262 |
22 |
10 |
32 |
9425 |
227 |
256 |
272 |
29 |
16 |
45 |
9426 |
243 |
260 |
273 |
17 |
13 |
30 |
9427 |
220 |
240 |
275 |
20 |
35 |
55 |
9428 |
219 |
232 |
251 |
13 |
19 |
32 |
Mean |
227.8 |
248.0 |
266.6 |
20.2 |
18.6 |
38.8 |
Standard Deviation |
9.7 |
11.7 |
10.1 |
6.0 |
9.8 |
10.8 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The read-across study was performed in accordance with standardised guidelines and under GLP conditions and was assigned a reliability score of 1 in accordance with the criteria for assessing data quality as described in Klimisch et al. (1997). The quality of the database is therefore considered to be high.
Additional information
Oral
The key study (Bradshaw 2009) was performed on the read-across substance to assess the acute oral toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of OECD 420 and EU Method B.1 bis. The study was performed under GLP conditions and was assigned a reliability score of 1 in accordance with the principles for assessing data quality as defined in Klimisch et al. (1997).
Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test material, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
There were no deaths and no signs of systemic toxicity. All animals showed expected gains in bodyweight. No abnormalities were noted at necropsy.
The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
In a second study, the acute oral toxicity of the test material was investigated using a single oral administration of 2000 mg/kg in male and female ICR mice of age six weeks. A control group was dosed with vehicle only. The animals were observed for 14 days following administration.
No deaths were observed in male or female mice at the dose level of 2000 mg/kg and so the lethal dose level was estimated to exceed 2000 mg/kg. No abnormalities were observed in any animals in the observations of external appearance, nutritional status and behaviour. There was no significant difference between the body weight development of the treated and control groups and there were no abnormalities in any animals in the macroscopic observations performed.
Under the conditions of this study the oral LD50 value in ICR mice was established to exceed 2000 mg/kg body weight.
Inhalation
In accordance with column 2, point 8.5.2 of Annex VIII of the Regulation (EC) No. 1907/2006 (REACH), testing via the inhalatory route is appropriate if it is a likely route of exposure to humans. As the acute toxicity of the test material has been addressed by the two most likely routes of exposure (oral and dermal), testing for this endpoint is therefore omitted.
Dermal
In the key study (Zelenák 2013) the acute dermal toxicity of the read-across material was determined in male and female CRL:(WI) rats in accordance with the standardised guideline OECD 402 under GLP conditions. The study was therefore assigned a reliability score of 1 in accordance with the principles for assessing data quality as defined in Klimisch et al. (1997).
The study was performed as a limit test. 2000 mg/kg bw was applied to the shaved back of 5 animals of each sex (equating to around 10 % of the surface area of the skin) and covered with a semi-occlusive dressing. After 24 hours, the test site was washed with water and the animals were observed for any reactions over a fourteen day observation period. Bodyweights were recorded at days 0, 7 and 14. At the end of the study, all surviving animals were submitted for necropsy.
There was no mortality throughout the study and none of the animals demonstrated any clinical signs of toxicity. Bodyweights and bodyweight gains were not affected by test material administration. All animals were found to be normal at necropsy.
Under the conditions of this study, the acute dermal median lethal dose (LD50) was determined to be > 2000 mg/kg bw in male and female rats.
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 via the oral or dermal route.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.