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EC number: 923-511-9 | 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
![](https://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April-May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- 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
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Inorganic residual from kraft or soda pulping separated from green liquor in the chemical recovery cycle.
- EC Number:
- 923-511-9
- IUPAC Name:
- Inorganic residual from kraft or soda pulping separated from green liquor in the chemical recovery cycle.
- Details on test material:
- Name: "Green liquor sludge".Molecular formula: UVCB.Batch No.: Not stated.EC No.: 923-511-9.Appearance: Solid, light grey when dried.Solubility: In water: washed substance is not solubleIn other solvents: not available.pH: Not available.Conditions of storage: Room temperature. Storage in the dark but may be used under light.Stability at conditions of storage: Not available.Expiry date: Not available.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species, strain: Rats, Crl:CD(SD).Supplier: Charles River Deutschland GmbH, D-97633 Sulzfeld.Number of animals and sex: 5 males and 5 females, females were nulliparous and non-pregnant.Age: Approximately 8 weeks (males) and 12 weeks (females) at the time of administration.Health conditions: A health inspection was performed prior to the commencement of treatment to ensure, that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from any abnormality.Hygienic status: Optimal hygienic conditions.Room number: EI1-11.Room temperature: Ranges from 19.96 to 21.13 °C (continuous control and recording).Relative humidity: Ranges from 44.54 to 67.46 % (continuous control and recording).Air exchange: 12 per hour.Light: Artificial light from 6 a.m. to 6 p.m.Cages: Single caging in Makrolon cages type III (37.5 cm x 21.5 cm bottom area, 18 cm height). Wire mesh lids. Sanitation of cages once a week.Bedding material: Aspen wood chips, Fa. ABEDD Dominik Mayr KEG, A-8580 Köflach, autoclaved. Random samples of the bedding material are analysed for contaminants by the supplier. Changes 1 / week.Environmental enrichment: Nibbling wood bricks (10 cm x 2 cm x 2 cm) and nesting material, both from the same material and source as the bedding material, were offered to the animals once a week.Feed: Ssniff R/M-H maintenance diet for rats and mice (item V1534-300) ad libitum, supplied by Ssniff Spezialdiäten GmbH, 59494 Soest, Germany. Analysis of the feed for ingredients and contaminants is performed randomly by Ssniff.Water: Tap water, from an automatic watering system, ad libitum, random samples of the water are analysed by the "AGES", A-1226 Vienna, to check, if the water fulfils the requirements for drinking water for humans.Identification: Labelling with felt-tipped pen on the tail and on the cage. Acclimatisation: At least 7 days.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- A single dermal administration was performed by spreading the test substance on an area of at least 10 % of the estimated body surface:The body surface was calculated using the formula: body surface (cm²) = 10 x body weight (g)2/3 The test site was located on the dorsal thoracic region. An area of 6.5 cm x 8 cm (52 cm2) was marked on a relaxed animal.The hair of the dorsal trunk was clipped with an electrical hair clipper (Aesculap GH, 0.1 mm cutter head) one day before application of the test substance. The amounts of the test substance were calculated and weighed for each individual using the body weights determined on the day of the administration.A cellulose patch (Pehazell, Hartmann AG) with the calculated amount of the test substance on the surface and soaked with deionised water to get optimal contact with the skin, was applied to the test site and held in place by fixing marginally with non irritating tape (Blenderm Wundpflaster, 3M).The test site was covered by a semi-occlusive dressing (Fixomull Stretch, Fa. Beiersdorf).The duration of exposure was 24 hours.At the end of the exposure period the dressing, the tape and the patch were removed.Residual test substance was wiped off using wet cellulose tissue, if necessary.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- Observations were performed 0 - 0.5, > 0.5 - 1, > 1 - 2, > 2 - 4 and > 4 - 6 hours after administration of the test substance (p.a.) and then at least once a day for a total of 14 days. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.No skin examination of the administration site was possible during the exposure period, while it was covered by the patch and wrappings.Body weights were determined•before administration.•7 days p.a.•14 days p.a.Body weight gain was calculated for each week of the study, i.e. between •0 and 7 days p.a.•7 and 14 days p.a.All animals were sacrificed by inhalation of 80 % CO2 + 20 % O2 14 days p.a. and subjected to a necropsy including a gross pathological examination.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- wet weight (moisture content 53%)
- Mortality:
- All animals survived until the scheduled termination of the study.
- Clinical signs:
- other: General findings: All animals did not show any clinical signs during the entire observation period.Observations of skin condition: A black staining of the skin was observed in all animals from 1 d until a maximum of 3 d p.a. This stain is attributed to a
- Gross pathology:
- No abnormal findings were made in the animals at terminal necropsy.
Any other information on results incl. tables
Table: Body weights and body weight gain.
Individual data, mean and standard deviation SD.
Dose | Animal | Body weight (g) | Body weight gain (g) | ||||
Sex | No. | before | 7 days | 14 days | death | 0-7 days | 7-14 days |
| 11 | 284 | 329 | 365 | - | 45 | 36 |
2000 mg/kg | 12 | 281 | 325 | 361 | - | 44 | 36 |
male | 13 | 286 | 335 | 377 | - | 49 | 42 |
| 14 | 278 | 313 | 339 | - | 35 | 26 |
| 15 | 288 | 319 | 352 | - | 31 | 33 |
| mean | 283.4 | 324.2 | 358.8 | - | 40.8 | 34.6 |
| SD | 4.0 | 8.6 | 14.3 | - | 7.5 | 5.8 |
| 16 | 235 | 248 | 255 | - | 13 | 7 |
2000 mg/kg | 17 | 249 | 266 | 268 | - | 17 | 2 |
female | 18 | 236 | 246 | 257 | - | 10 | 11 |
| 19 | 251 | 273 | 293 | - | 22 | 20 |
| 20 | 244 | 256 | 258 | - | 12 | 2 |
| mean | 243.0 | 257.8 | 266.2 | - | 14.8 | 8.4 |
| SD | 7.3 | 11.6 | 15.8 | - | 4.8 | 7.5 |
Table: Observations in life.
Findings | Dose | No. of the affected animals | Observation time |
test substance related stain of skin | 2000, m | 11 | 1 d - 3 d |
|
| 12 | 1 d |
|
| 13 | 1 d |
|
| 14 | 1 d |
|
| 15 | 1 d - 2 d |
| 2000, f | 16 | 1 d |
|
| 17 | 1 d - 2 d |
|
| 18 | 1 d - 2 d |
|
| 19 | 1 d |
|
| 20 | 1 d - 2 d |
Table: Necropsy findings.
SYSTEM | Dose | No. of affected |
no abnormal findings | 2000, m | 11, 12, 13, 14, 15 |
| 2000, f | 16, 17, 18, 19, 20 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- No local or systemic test substance related effects were noted from clinical observations or post-mortem examination at a dose of 2000 mg test substance per kg body weight. The LD50,dermal of "Green liquor sludge" is higher than 2000 mg/kg body weight in rats.
- Executive summary:
The aim of the study was to investigate acute toxic effects of the test substance after a single dermal administration to rats.
Methods and investigations were performed in conformance with the OECD-Guideline 402, 1987 and the Council Regulation (EC) No 440/2008, Method B.3.
"Green liquor sludge" was administered once topically on an area of approximately 6.5 cm x 8 cm on the dorsal thoracic region of 5 male and 5 female Sprague Dawley rats.
The dose was 2000 mg per kg body weight.
A cellulose patch with the calculated amount of the test substance on the surface and soaked with deionised water to get optimal contact with the skin, was applied to the test site and held in place by fixing marginally with non irritating tape.
The test site was covered by a semi-occlusive dressing.
The duration of the exposure was 24 hours.
Investigations
· Body weights: before the administration, 7 and 14 days after the administration (p.a.).
· Clinical observations: at least once per day.
· Necropsy: All animals were sacrificed and necropsied 14 days p.a.
dose
(mg/kg)sex
No. of animals
prominent findings
exposed
affected
deceased
in life
post mortem
systemic
local
2000
male
5
0
0
none
none
none
2000
female
5
0
0
none
none
none
Staining of the skin which is attributed to the staining property of the test substance was observed in all animals.
presence of clinical signs
no signs
full recovery of the survivors
not applicable
body weights
all animals gained weight in both weeks p.a.
sex differences
no
findings in life and post-mortem indicate
no toxic effects present
LD50, dermal
> 2000 mg/kg body weight
Conclusion
No local or systemic toxic effects related to administration of the test substance were noted from clinical observations or post-mortem-examination at a dose of 2000 mg of the test substance per kg body weight.
No classification of "Greenliquor sludge" is therefore derived from the results of this study according to the Directive 2001/59/EC.
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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