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EC number: 246-014-2 | CAS number: 24085-08-3
- 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
The acute oral and dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight, respectively.
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:
- 13 January 1999 - 28 January 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Performend in a GLP laboratory in accordance with OECD guidelines. No deviations were noted.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other: Solid
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Wistar strain Crl:(WI) BR (outbred, SPF-Quality).
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Age at study initiation: approx. 6 weeks old
- Weight at study initiation: Body weight variation did not exceed+/- 20% of the sex mean.
- Fasting period before study: Food was withheld overnight prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: Group housing of 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material.
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet.
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): Lighting was 12 hours artificial fluorescent light and 12 hours dark per day. - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg (10 ml/kg) body weight.
- Amount of vehicle (if gavage): (10 ml/kg) body weight.
- Justification for choice of vehicle: The vehicle was selected based on a pretest performed at NOTOX.
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 male and 3 female.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Two and four hours after treatment, subsequent daily observations were made until terminal sacrifice.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight and histopathology. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One female died within 20 minutes post treatment. No further mortality occurred.
- Clinical signs:
- other: No clinical signs of systemic toxicity were noted in the females and lethargy was seen in all males on the day of treatment (day 1). A single observation of red staining of the head in one male was recorded on day 2.
- Gross pathology:
- Thickening and dark red discolouration of the limiting ridge in the stomach was found in the female that died on day 1. No abnormalities were found at macroscopic post mortem examination of the animals at scheduled sacrifice.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance does not have to be classified and has no obligatory labelling requirement for oral toxicity.
- Executive summary:
The study was carried performed in a GLP laboratory and was based on the guidelines described in: EC Commission Directive 96/54/EC, Part 8.1 tris 'Acute Method' Toxicity-Oral, Acute Toxic Class Method' and OECD No.423, 'Acute Oral Toxicity - Acute Toxic Class Method'. No deviations were recorded.
the test substance was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or after terminal sacrifice (day 15).
The oral LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.
Based on these results the test substance does not have to be classified and has no obligatory labelling requirement for oral toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study was conducted in 1999 in accordance with the OECD test method in force at the time. The study is deemed to be a Klimisch 1 study.
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:
- 29 January 2015 - 19 February 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: done under GLP and OECD method
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 440/208
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adapted 24 February 1987
- GLP compliance:
- yes
- Remarks:
- OECD Principles on Good Laboratory Practice (revised 1997, ENV/MC/CHEM(98)17); and are in accordance with, and implement, the requirements of Directives 2004/9/EC and 2004/10/EC.
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK.
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: at least 200 g
- Fasting period before study: none
- Housing: suspended solid floor polypropylene cages furnished with woodflakes
- Diet: (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK) ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): controlled by a time switch to give 12 hours continuous light and 12 hours darkness. - Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 10% of the total body surface area
REMOVAL OF TEST SUBSTANCE
- Washing: treated skin and surrounding hair wiped with cotton wool moistened with a suitable solvent to remove any residual test item
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg bw moistened with arachis oil (BP). - Duration of exposure:
- 24 hours
- Doses:
- 2,000mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females at one dose level of 2,000mg/kg bw
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 0.5hr, 1hr, 2hr, 4hr after dosing and subsequently once daily for 14 days.
- Frequency of weighing: Days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: erythema, edema and other.
Initially, two animals (one male and one female) were given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of
2000 mg/kg body weight. Based on the results of the initial test, a further group of eight animals (four males and four females) was similarly treated. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Zero mortality
- Mortality:
- Male: 2,000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2,000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.
- Executive summary:
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000mg/kg bodyweight
The test item does not meet the criteria for classification according to EU Labelling Regulations Commission Directive 2001/59/EC for Classification and Labelling of Dangerous Substances, Regulation (EC)No1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures or the Globally Harmonized System of Classification and Labelling of Chemicals.
Reference
Body Weights:
DoseLevelmg/kg |
AnimalNumberand Sex |
Body Weight(g) at Day |
Body Weight Change(g)During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 Male |
239 |
256 |
270 |
17 |
14 |
3-0 Male |
274 |
281 |
335 |
7 |
54 |
|
3-1 Male |
248 |
260 |
285 |
12 |
25 |
|
3-2 Male |
260 |
271 |
280 |
11 |
9 |
|
3-3 Male |
250 |
259 |
282 |
9 |
23 |
|
2-0 Female |
212 |
217 |
222 |
5 |
5 |
|
4-1 Female |
228 |
229 |
232 |
1 |
3 |
|
4-2 Female |
218 |
220 |
217 |
2 |
−3 |
|
4-3 Female |
200 |
203 |
211 |
3 |
8 |
|
4-4 Female |
212 |
212 |
222 |
0 |
10 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
The available acute oral toxicity study was performed in 1999 in accordance with OECD Guideline 423 and GLP. The discriminating dose in the main study was established at 2000 mg/kg, with no remarkable findings observed in any of the animals when examined 14 days after dosing. Based upon the classification criteria in force at that time (Directive 67/548/EEC as adapted by Directive 93/21/EEC), the existing conclusion of the study director is that the LD50, based upon the acute toxic class procedure is >2000mg/kg. Application of the current classification criteria in accordance with 1272/2008/EC results in the substance not being classified for acute oral toxicity based upon a lack of effects at 2000 mg/kg.
Acute dermal toxicity was assessed using OECD guideline 402 in accordance with GLP. A limit test at 2000 mg/kg bw was conducted which did not result in mortality or signs of systemic toxicity in the treated animals. Application of the current classification criteria in accordance with 1272/2008/EC results in the substance not being classified for acute dermal toxicity based upon a lack of effects at 2000 mg/kg.
Justification for selection of acute toxicity – oral endpoint
The study was performed in a GLP laboratory in accordance with OECD guidelines and no deviations were noted. The study is considered acceptable for the purpose of determining the acute oral toxicity of the test substance.
Justification for selection of acute toxicity – dermal endpoint
The study was performed in a GLP laboratory in accordance with OECD guidelines and no deviations were noted. The study is considered acceptable for the purpose of determining the acute dermal toxicity of the test substance.
Justification for classification or non-classification
The acute oral and acute dermal median lethal dose(LD 50) of the test item in the Wistar strain rat was found to be greater than
2000mg/kg bodyweight, respectively.
The test item does not meet the criteria for classification according to EU Labelling Regulations Commission Directive 2001/59/EC for Classification and Labelling of Dangerous Substances, Regulation (EC) No1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures or the Globally Harmonized System of Classification and Labelling of Chemicals.
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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