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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 419-740-4 | CAS number: 137658-79-8 CGL 1545
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
A single dose of 2000 mg/kg bw of the test substance was administrated oral or dermal to groups of male and female rats (5/sex, according to OECD guidelines 401 and 402). Application of the test substance did not induce any signs of toxicity. None of the animals died, viability and bodyweight gain were unaffected by the test article. Gross necropsy did not reveal any treatment related abnormalities. LD50 after single oral and dermal administration is > 2000 mg/kg bw.
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:
- 1995-04-26 until 1995-07-25 (from acclimatization until report)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 24 Feb 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 31 Jul 1992
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: Z 2651-01
- Expiration date of the lot/batch: Feb 1997
- Purity: ˃ 95%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the original container at room temperature away from direct sunlight
- Stability under test conditions: stable under storage condition
- Solubility and stability of the test substance in the solvent/vehicle: unknown in corn oil, therefore is excluded from the statement of compliance
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article, drumbled into fine powder with a mortar, was placed into a glass beaker on a tared Mettler PM480 balance, and the vehicle (corn oil) was added. A weight by volume dilution was prepared using a homogenizer (Ultra-Turrax, Janke & Kunkel, D-79219 Staufen)
- Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer (Janke & Kunkel, D-799219 Staufen)
- The preparation was made shortly before dosing
OTHER SPECIFICS:
- Description: Yellowish solid - Species:
- rat
- Strain:
- other: Hanlbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4 4414 Fullinsdorf / Switzerland
- Age at study initiation: males: 8 weeks, females: 10 weeks
- Weight at study initiation: males: 195.9 - 207.1 g, females: 176.7 - 192.7 g
- Housing: Groups of five in Makrolon type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, Batch no. 85/94 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period [16h] prior to application). Results of analyses for contaminants are included in the report.
- Water (e.g. ad libitum): Community tap water from Fullinsdorf, available ad libitum. Results of bacteriological, chemical and contaminant analyses are included in the report.
- Acclimation period: 7d, 26 april until 2 may 1995
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 °C
- Humidity (%): humidity between 40-67%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark (light period between 6.00 a.m. to 6.00 p.m.), music during the light period.
IN-LIFE DATES:
Treatment 03-MAY-1995
Observation 03-MAY-1995 to 17-MAY-1995
Termination 17-MAY-1995 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg bw
- Amount of vehicle (if gavage): 10ml
- Rationale: Oral administration was used as this is one possible route of human exposure during manufacture, handling and use of the test article. - 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: On test day 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality / Viability: Four times during test day 1 and daily during days 2-15, Clinical Signs: Each animal was examined for changes in appearance and behaviour four times during day 1, and once daily during days 2-15.
- Statistics:
- The LOGIT-Model could not be used as no deaths occurred.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No unscheduled deaths occurred during the study.
- Clinical signs:
- other: No clinical signs of toxicity were observed during the observation period.
- Gross pathology:
- No organ abnormalities were observed at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean lethal dose of the test substance after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated, because LD50 : greater than 2000 mg/kg
- Executive summary:
The test article was administered to a group of 5 male and 5 female rats by oral gavage, at a single dose of 2000 mg test article/kg body weight. There were no deaths as a result of treatment with the test article. No clinical signs of toxicity were observed during the observation period. There was no effect on body weight gain during the observation period. No organ abnormalities were observed at necropsy.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
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:
- Aug-Sep 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 Feb 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 31 Jul 1992
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: Z-2759
- Expiration date of the lot/batch: Sep 1997
- Purity: 99.3%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the original container, at room temperature (approx. 20°C)
- Stability under test conditions: Stable under storage conditions
- Solubility and stability of the test substance in the solvent/vehicle: Stable in corn oil for at least 48 hours
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was placed into a glass beaker on a tared Mettler PM 460 balance and the vehicle (corn oil) was added. A weight by volume dilution was prepared using a glass rod.
- Homogeneity of the test article in the vehicle was maintained during treatment using the same glass rod.
- The preparation was made shortly before dosing.
OTHER SPECIFICS:
- Description: Yellowish solid - Species:
- rat
- Strain:
- other: Hanlbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4 4414 Fullinsdorf / Switzerland
- Age at study initiation: males: 8 weeks, females: 11 weeks
- Weight at study initiation: males: 226.5 - 247.7 g, females: 197.4 - 217.7 g
- Housing: Groups of five in Makrolon type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, Batch no. 85/94 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period [16h] prior to application). Results of analyses for contaminants are included in the report.
- Water (e.g. ad libitum): Community tap water from Fullinsdorf, available ad libitum. Results of bacteriological, chemical and contaminant analyses are included in the report.
- Acclimation period: One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
- Identification: By unique cage number and corresponding color-coded spots on the tail.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): humidity between 40-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark (light period between 6.00 a.m. to 6.00 p.m.), music during the light period.
IN-LIFE DATES:
Treatment 19-AUG-1996
Observation 19-AUG-1996 to 02-SEP-1996
Termination 02-SEP-1996 - Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was washed with lukewarm tap water and dried with disposable paper towels
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw, 4 ml/kg bw
Dermal administration was used because this is one possible route of human exposure during manufacture, handling and use of the test article. - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw, 4 ml/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- Mortality / Viability: Four times during test day 1 and once daily for surviving animals during days 2-15.
Body Weights: On test days 1 (pre-administration), 8 and 15 for surviving animals.
Clinical Signs: Each animal was examined for changes in behaviour and appearance (with special emphasis on the application area, except for the time when the semi-occlusive dressing was in place) four times during day 1, and once daily during days 2-15. All abnormalities were recorded.
PATHOLOGY
Necropsy
Necropsies were performed by experienced prosectors. At the end of the observation period all animals were sacrificed by intraperitoneal injection of NARCOREN (Rhone Merieux GmbH, D-88471 Laupheim) at a dose of at least 2.0 ml/kg body weight (equivalent to at least 320 mg sodium pentobarbitone/kg body weight). The animals were examined macroscopically. Thereafter, they were discarded. - Statistics:
- The LOGIT-Model could not be used as no deaths occurred
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths occurred during the study as a result of treatment with the test article.
- Clinical signs:
- other: Neither clinical signs of systemic toxicity nor local effects of the test article on the skin at the application site were observed during the observation period.
- Gross pathology:
- No macroscopical organ findings were noted at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean lethal dose of the test substance after single dermal administration to rats of both sexes, observed over a period of 14 days, could not be estimated, because LD50 : greater than 2000 mg/kg
- Executive summary:
A group of five male and 5 female HanIbm:WIST (SPF) rats was treated with the test substance at 2000 mg/kg by dermal application. The test article was suspended in vehicle (corn oil) at a concentration of 0.5 g/ml and administered at a volume of 4 ml/kg. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 before administration and on days 8 and 15. All animals were necropsied and examined macroscopically.
No deaths occurred during the study period. Neither clinical signs of systemic toxicity nor local effects of the test article on the skin at the application site were observed during the observation period. A slight loss of body weight in one female animal (no. 8) was observed during the second observation week. No macroscopic organ findings were observed at necropsy.
Reference
Table 1: Body weights (gram)
Group / Sex |
Animal |
Day 1 |
Day 8 |
Day 15 |
Group 1 / Males (2000 mg/kg) |
1 |
242.0 |
275.9 |
299.2 |
2 |
234.9 |
260.0 |
298.6 |
|
3 |
247.7 |
268.9 |
294.0 |
|
4 |
239.0 |
252.3 |
258.9 |
|
5 |
226.5 |
249.9 |
273.1 |
|
Mean |
238.0 |
261.4 |
284.8 |
|
St.dev. |
8.0 |
11.0 |
17.9 |
|
n |
5 |
5 |
5 |
|
Group 1 / Females (2000 mg/kg) |
6 |
198.8 |
207.4 |
220.7 |
7 |
197.4 |
199.7 |
210.8 |
|
8 |
216.0 |
249.4 |
247.8 |
|
9 |
217.7 |
222.7 |
235.8 |
|
10 |
216.6 |
223.6 |
237.2 |
|
Mean |
209.3 |
221.0 |
230.4 |
|
St.dev. |
10.2 |
19.2 |
14.6 |
|
n |
5 |
5 |
5 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Acute toxicity: oral
To evaluate the acute oral toxicity, a single dose (2000 mg/kg bw) of the test article was administrated to a group of 5 male and 5 female rats by oral gavage. Following dosing, the animals were observed for 14days. Examination of clinical signs and viability were performed daily, weighing once a week.
There were no deaths as a result of treatment with the test article. Clinical signs of toxicity or changes in body weight gain were not observed during the observation period. Gross necropsy was without any findings.
Application of the test substance via oral route did not induce any signs of toxicity. LD50 after single oral administration is > 2000 mg/kg bw.
Acute toxicity: dermal
Dermal toxicity of the test substance was evaluated on a group of five male and 5 female HanIbm:WIST (SPF) rats which were treated with the test article at 2000 mg/kg by dermal application . The substance was suspended in corn oil at a concentration of 0.5 g/ml and administered at a volume of 4 ml/kg. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs and viability. Body weights were recorded on day 1 before administration and on days 8 and 15. All animals were necropsied and examined macroscopically.
No deaths occurred during the study period. Neither clinical signs of systemic toxicity nor local effects of the test article on the skin at the application site were observed during the observation period. A slight loss of body weight in one female animal was observed during the second observation week. Macroscopic organ findings were not observed at necropsy.
Application of the test substance via dermal route did not induce any signs of toxicity. LD50 after single dermal administration is > 2000 mg/kg bw.
Acute toxicity: inhalation
Acute toxicity after inhalation of the test substance was not investigated. The major part of the substance has a particle size of > 40µm (92 %) or more. Inhalable particles of < 10 or < 4 µm are not included.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occurred at the limit dose of 2000 mg/kg bw after oral and dermal application. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No 2018/1480.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)