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EC number: - | 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
In 3 acute oral toxicity studies in rats and mice, conducted prior to current standards but equivalent to OECD 401, the LD50 (oral) was determined to be > 5000 mg/kg. In an acute dermal toxicity study with rats, performed according to OECD 402 and GLP, a LD50 (dermal) of > 5189.5 mg/kg bw was determined. These LD50's correspond to LD50's of > 2000 mg/kg, when expressed as solid content (for comparison purposes).
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The 3 available studies have Klimisch score 2.
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:
- August 16, 2012 - November 23, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed in accordance with OECD 402 (1987), EU Method B.3 (2008), EPA OPPTS 870.1200 (1998) and according to GLP principles.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- (1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nohsan, Notification No. 8147, April 2011; including the most recent partial revisions
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar strain, Crl:WI (Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Young adult animals (approx. 10 weeks old)
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing (during the acclimatization period): group housed in Makrolon cages
- Housing (after application): Individually housed in labeled Makrolon cages
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany)
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24
- Humidity (%): 40 to 70
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- - Clipping: One day before exposure (Day -1) an area of approximately 5x7 cm on the back of the animal was clipped
- Application: The test substance was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.
- Frequency: Single dosage, on Day 1.
- Washing: Following application, dressings were removed and the skin cleaned of residual test substance using tap water. - Duration of exposure:
- 24 hours
- Doses:
- 5189.5 mg/kg bw (expressed as registered substance) which corresponds to 2000 mg/kg bw expressed as solid content
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Dose volume: 4.85 mL/kg bw (Density: approx. 1.07 g/mL)
- Dosage preparation: The test substance was dosed undiluted. Correction was made for the solid content of the test substance (a correction factor of 2.59 was used)
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily
Body weights: Days 1 (pre-administration), 8 and 15
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.
- Other examinations performed: none. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 189.5 mg/kg bw
- Based on:
- test mat.
- Remarks:
- (aqueous solution)
- Remarks on result:
- other: Aqueous solution with a solid content of 38.56%
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- other: expressed as solid content
- Mortality:
- No mortality occurred
- Clinical signs:
- other: - Flat posture was shown by one male on Day 1. Chromodacryorrhoea was shown by one male and one female on Day 1 - Focal erythema (grade 1) was seen on the treated skin-area of all males on Days 2 and 3
- Gross pathology:
- - Pelvic dilation of the kidneys, reddish foci on the thymus or discolouration of the thymus were shown by three males
- Macroscopic examination of the other animals did not reveal any abnormalities - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an acute dermal toxicity study with rats, performed according to OECD/EC test guidelines, a LD50 of > 5189.5 mg/kg bw was determined.
- Executive summary:
The acute dermal toxicity of the substance was determined in the rat, in accordance with OECD 402 (1987), EU Method B.3 (2008), EPA OPPTS 870.1200 (1998) and according to GLP principles. The substance was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight (expressed as solid content) for 24 hours (a correction factor of 2.59 was used). The dose corresponded to 5189.5 mg/kg bw for the registered substance.
No mortality occurred. Flat posture was shown by one male on Day 1. Chromodacryorrhoea was shown by one male and one female on Day 1. Focal erythema (grade 1) was seen on the treated skin-area of all males on Days 2 and 3. The changes noted in body weight gain in males and females were considered not indicative of toxicity. Pelvic dilation of the kidneys, reddish foci on the thymus or discolouration of the thymus were observed by three males. Macroscopic examination of the other animals did not reveal any abnormalities. The dermal LD50 value of the substance in Wistar rats was established to exceed 5189.5 mg/kg bw, which corresponds to > 2000 mg/kg body weight expressed as solid content.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 189.5 mg/kg bw
- Quality of whole database:
- The study has Klimisch score 1
Additional information
Oral
The acute oral toxicity in rats and mice has been investigated in 3 studies, conducted prior to current standards but equivalent to OECD 401:
Method |
Reliability |
Results |
Result (expressed as solid content) |
(1) Standard (equivalent to OECD 401; in mice) |
2 |
< 21400 mg/kg bw (ca. 36% solids) |
< 7704 mg/kg bw |
(2) Standard (equivalent to OECD 401, limit test; in rats) |
2 |
> 5350 mg/kg bw (ca. 38% solids) |
> 2033 mg/kg bw |
(3) Standard (equivalent to OECD 401; in mice) |
2 |
> 24075 mg/kg bw (ca. 38% solids) |
> 9148 mg/kg bw |
In the second study no mortalities occurred, at a dose of 5 mL/kg bw.
Based on the results of the available studies, the oral LD50 was determined to be > 5000 mg/kg bw and > 2000 mg/kg bw, when expressed as solid content for comparison purposes.
Inhalation
There is no experimental study available by the inhalation route. Based on the low acute toxicity properties by the oral and dermal routes, there is a low toxicological concern by the inhalation route. The substance is manufactured, marketed and used as aqueous solution. In addition the substance has a low volatility potential due to low vapour pressure of the surfactant fraction (main constituent) and both major constituents of toxicological interest in the substance have a low Henry’s law constant supporting a very low release from water.
No aerosol formation is expected during manufacturing and normal handling of the substance as produced. The registered substance is then formulated in industrial setting, and then further diluted to very low concentrations before end-use application, with a low likelihood of exposure to aerosols of an inhalable size during typical uses.
Using the methanol content in the substance, and the uncertainty on the surfactant properties by inhalation, an Acute Toxicity Estimate can be derived according to CLP regulation EC No.1272/2008 and shows the substance does not require classification for the inhalation route (see below). Therefore this endpoint is adequately assessed.
Dermal
The acute dermal toxicity of the substance was determined in the rat, in accordance with OECD 402 (1987), EU Method B.3 (2008), EPA OPPTS 870.1200 (1998) and according to GLP principles. The substance was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight (expressed as solid content) for 24 hours. The dose corresponded to 5189.5 mg/kg bw for the registered substance (an aqueous solution). No mortality occurred. Flat posture was shown by one male on Day 1. Chromodacryorrhoea was shown by one male and one female on Day 1. Focal erythema was seen on the treated skin-area of all males on Days 2 and 3. Pelvic dilation of the kidneys, reddish foci on the thymus or discolouration of the thymus were shown by three males. Macroscopic examination of the other animals did not reveal any abnormalities. The dermal LD50 value of the substance in Wistar rats was established to exceed 5189.5 mg/kg bw, which corresponds to > 2000 mg/kg body weight expressed as solid content, for comparison purposes.
Justification for selection of acute toxicity – oral endpoint
There are 3 acute oral toxicity studies available, all having Klimisch score 2. As all these reliable studies showed a low acute oral toxicity in rats and mice, resulting in a LD50 of above 5000 mg/kg as the lowest LD50 for the registered substance, no specific study is selected.
Justification for selection of acute toxicity – inhalation endpoint
There is no experimental study available by the inhalation route. Based on the low acute toxicity properties by the oral and dermal routes, there is a low toxicological concern by the inhalation route (see discussion). The Acute Toxicity Estimate for the inhalation route is > 20 mg/L.
Justification for selection of acute toxicity – dermal endpoint
Reliable study conducted according to current standards.
Justification for classification or non-classification
CLP
As the acute oral and dermal LD50's of the substance were determined to be >5000 mg/kg bw, the substance does not need to be classified for acute oral and dermal toxicity in accordance with the CLP Regulation. The substance has been tested as such with all the constituents in the acute oral and acute dermal studies; the test results overrule the classification for acute oral and dermal toxicity based on the methanol content.
However, because of the methanol content in the substance, the specific target toxicity following a single exposure cannot be excluded, thus the CLP classification related to the methanol content was applied using the specific concentration limits of Annex VI (STOT SE 2; H371: 3% ≤ C < 10%): STOT SE 2, H371 (all routes; target organs: optical nerve, central nervous system).
Because no experimental results are available by the inhalation route, the classification was also assessed based on methanol content and as a mixture. Considering the Annex VI classification of methanol, Acute Tox. 3, H331, the converted Acute tox point estimate to be used in the ATEmix calculation is 3 mg/L [CLP regulation EC No.1272/2008, Table 3.1.2]. In the absence of experimental data on the surfactant fraction, it is considered of unknown toxicity in the estimate calculation, as a worst case (although unlikely, based on the available data). Based on surfactant content (max. 45%), methanol content (max. 6%) and using the equation as mentioned under 3.1.3.6.2.3. in the CLP Regulation, the ATEmix for the UVCB substance is derived as: ATEmix = (100–45)*3/6 = 27.5 mg/L.
Based on CLP criteria, and the maximum methanol content, the registered UVCB substance is therefore not classified for acute inhalation toxicity in accordance with the CLP Regulation.
Conclusion for Acute toxicity
CLP: STOT SE 2, H371
DSD: Xn; R20; Xn; R68/20/21/22Information 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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