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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
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- Endpoint summary
- Stability
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- 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
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- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 October 2010 to 10 November 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to EU, OECD & US EPA test guidance in compliance with GLP and reported with a valid GLP certificate.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- yes
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Details on test material:
- Name: Reactive Orange F08-0314
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain: RjHan:WI rats
Source: Laboratoire Elevage Janvier, B.P. 4105, Route des Chênes Secs, 53940 Le Genest-St-Isle CEDEX FRANCE
Hygienic level at supplier: SPF
Hygienic level during the study: Standard housing conditions
Number of animals: 6 animals, 3 animals/group
Sex: Female, nulliparous and non-pregnant.
Age of animals at dosing: Young healthy adult rats, 9-10 weeks old
Date of receipt: 21 October 2010
Body weight at treatment: 207 – 221 g
Acclimation period: At least 5 days
Animal health: Only healthy animals were used for the test. The veterinarian certified the health status.
Number of animal room: 522/7
Housing: 3 animals / cage
Cage type: Type III polypropylene/polycarbonate
Bedding: Lignocel Bedding for Laboratory Animals was available to animals during the study.
Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3°C
Relative humidity: 30 - 70%
Ventilation: 15-20 air exchanges/hour
Enrichment: Animals were housed by group to allow social interaction and with deep wood sawdust bedding to allow digging and other normal rodent activities.
Food and Water Supply: Animals received ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany ad libitum, and tap water from the municipal supply, as for human consumption from 500 ml bottle ad libitum. The food is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
Animal Identification: Animals were individually identified using numbers written on the tail with an indelible marker pen. The numbers were given on the basis of LAB Research Ltd.' s Master File, for each animal allocated to the treatment groups. The cages were identified by cards, with information about study code, sex, dose group, cage number and individual animal numbers.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Formulation: Test item was freshly formulated at a concentration of 200 mg/mL in the vehicle (without correction for purity), in the Central Dispensary Unit of LAB Research Ltd. on the day of administration. The formulation container was stirred continuously during administration to ensure that the syringe was filled from a homogenous liquid.
Doses
Justification of the dose: The initial dose level was selected on the basis of the information provided by the Sponsor. The LD50 value was expected to be above 2000 mg/kg bw.
Initially, three female animals were treated with 2000 mg/kg bw of Reactive Orange F08 0314. As no mortality occurred within 24 hours after dosing, a second group of three animals received 2000 mg/kg bw Reactive Orange F08 0314 approximately 24 hours after treatment of the first group. No mortality occurred in the second treatment group; hence, further testing was not required according to the test guidelines. The test was terminated on completion of the 14-day observation period. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Three
- Control animals:
- no
- Details on study design:
- Procedure
A single oral dose was administered by gavage followed by a fourteen-day observation period. The animals were fasted for about 16 hours prior to treatment. The food but not water was withheld during an overnight period. Animals were weighed just before treatment. The test item was administered by oral gavage in the morning. The food was returned 3 hours after the treatment. A constant treatment volume of 10 mL/kg bodyweight was applied.
Clinical Observations
Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Individual observations were performed on the skin, fur, eyes, mucous membranes, 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 Weight Measurement
The body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0) and on study days 3, 7, and 14.
Necropsy
Macroscopic examination was performed on all animals. The animals were sacrificed by exsanguination under pentobarbital anaesthesia (Euthasol® 40 %). After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed. Macroscopic abnormalities were recorded. - Statistics:
- The method used was not intended to allow the calculation of a precise LD50 value.
The test item was ranked into categories of Globally Harmonized Classification System (GHS) described in the OECD Guideline No. 423.
Clinical signs, body weight, body weight gain and gross macroscopic data were tabulated.
Results and discussion
- Preliminary study:
- Not applicable.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Reactive Orange F08-0314 did not cause mortality at a dose level of 2000 mg/kg bw.
- Clinical signs:
- other: Treatment with Reactive Orange F08-0314 caused coloured urine and faeces at 3 hours after treatment in Group 1 and at 6 hours after treatment in Group 2.
- Gross pathology:
- A single oral gavage of Reactive Orange F08-0314 to the RjHan:WI rat at a dose level of 2000 mg/kg bw followed by a 14 day observation period did not result in any test item related macroscopic findings.
- Other findings:
- No data.
Any other information on results incl. tables
CLINICAL OBSERVATIONS
DOSE LEVEL: 2000 mg/kg bw SEX: FEMALE |
||||||||||
Cage No. |
Animal Number |
Observation |
Observation days |
Frequency |
||||||
0 |
1-14 |
|||||||||
30’ |
1h |
2h |
3h |
4h |
6h |
|||||
1* |
2129 |
No clinical signs |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
2130 |
No clinical signs |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
2131 |
No clinical signs |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
DOSE LEVEL: 2000 mg/kg bw SEX: FEMALE |
||||||||||
Cage No. |
Animal Number |
Observation |
Observation days |
Frequency |
||||||
0 |
1-14 |
|||||||||
30’ |
1h |
2h |
3h |
4h |
6h |
|||||
2** |
2132 |
No clinical signs |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
2133 |
No clinical signs |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
2134 |
No clinical signs |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
Remarks: +: present -: absent
h=hours (s) Treatment day = Day 0
Frequency of observation = number of occurrence of observation / total number of observations
*: Urine and faeces coloured (orange) in bedding at 3h after treatment
**: Urine and faeces coloured (orange) in bedding at 6h after treatment
BODY WEIGHT DATA
DOSE LEVEL: 2000 mg/kg bw SEX: FEMALE |
|||||||||||
Cage No. |
Animal No. |
Body weight (g) Days |
Body Weight Gain (g) |
||||||||
-1 |
0 |
3 |
7 |
14 |
-1-0 |
0-3 |
3-7 |
7-14 |
-1-14 |
||
1 |
2129 |
233 |
221 |
255 |
271 |
293 |
-12 |
34 |
16 |
22 |
60 |
2130 |
222 |
215 |
233 |
243 |
261 |
-7 |
18 |
10 |
18 |
39 |
|
2131 |
219 |
207 |
233 |
239 |
264 |
-12 |
26 |
6 |
25 |
45 |
|
Mean: |
224.7 |
214.3 |
240.3 |
251.0 |
272.7 |
-10.3 |
26.0 |
10.7 |
21.7 |
48.0 |
|
Standard deviation: |
7.4 |
7.0 |
12.7 |
17.4 |
17.7 |
2.9 |
8.0 |
5.0 |
3.5 |
10.8 |
|
DOSE LEVEL: 2000 mg/kg bw SEX: FEMALE |
|||||||||||
Cage No. |
Animal No. |
Body weight (g) Days |
Body Weight Gain (g) |
||||||||
-1 |
0 |
3 |
7 |
14 |
-1-0 |
0-3 |
3-7 |
7-14 |
-1-14 |
||
2 |
2132 |
214 |
207 |
223 |
231 |
243 |
-7 |
16 |
8 |
12 |
29 |
2133 |
219 |
208 |
224 |
235 |
256 |
-11 |
16 |
11 |
21 |
37 |
|
2134 |
220 |
208 |
230 |
244 |
256 |
-12 |
22 |
14 |
12 |
36 |
|
Mean: |
217.7 |
207.7 |
225.7 |
236.7 |
251.7 |
-10.0 |
18.0 |
11.0 |
15.0 |
34.0 |
|
Standard deviation: |
3.2 |
0.6 |
3.8 |
6.7 |
7.5 |
2.6 |
3.5 |
3.0 |
5.2 |
4.4 |
Remark: Treatment day = Day 0
NECROPSY FINDINGS
DOSE LEVEL: 2000 mg/kg bw SEX: FEMALE |
||||
Cage No. |
Animal ID |
External Observations |
Internal Observations |
Organ/Tissue |
1 |
2129 |
No external observations recorded |
No internal observations recorded |
Not applicable |
2130 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
2131 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
DOSE LEVEL: 2000 mg/kg bw SEX: FEMALE |
||||
2 |
2132 |
No external observations recorded |
No internal observations recorded |
Not applicable |
2133 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
2134 |
No external observations recorded |
No internal observations recorded |
Not applicable |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item Reactive Orange F08-0314 was found to be above 2000 mg/kg bw in female RjHan: WI rats.
According the GHS criteria, Reactive Orange F08-0314 should be ranked as "Category 5" or "Unclassified". - Executive summary:
The single-dose oral toxicity of Reactive Orange F08-0314 was performed according to the acute toxic class method (OECD 423, OPPTS 870.1100, and Commission Regulation (EC) No 440/2008,B.1.tris) in RjHan: WI rats. The study is compliant to the Principles of Good Laboratory Practice (GLP) and reported with a valid GLP certificate.
Two groups of three female RjHan:WI rats (9-10 weeks old) were treated with Reactive Orange F08-0314 at a dose level of 2000 mg/kg bw (Group 1 and Group 2).
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. Rats were maintained without compound administration for a 2‑week observation period after the day of dosing. As no mortality was observed in this dose group within 24 hours after dosing, a confirmatory treatment was performed on 3 further females (Group 2) at the same dose level. As no mortality was observed in the second dose group, no further treatment was needed according to OECD 423 and Commission Regulation (EC) No 440/2008, B.1.tris.
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal (about 16 hours prior to treatment). Food was made available again 3 hours after the treatment. Reactive Orange F08-0314 was administered as a solution prepared in distilled water at a concentration of 200 mg/mL at a dosing volume of 10 mL/kg bw.
Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0, 3 and 7 and before necropsy. All animals were subjected to a necropsy and a macroscopic examination.
Results
Mortality: Reactive Orange F08-0314 did not cause mortality at a dose level of 2000 mg/kg bw.
Clinical observations: Treatment with Reactive Orange F08-0314 caused coloured urine and faeces at 3 hours after treatment in Group 1 and at 6 hours after treatment in Group 2.
Body weight and body weight gain: Body weight gains of Reactive Orange F08-0314 treated animals showed no indication of a treatment-related effect.
Macroscopic Findings: A single oral gavage of 2000 mg/kg bw did not result in any test item related macroscopic findings.
Conclusion:
Under the conditions of this study, the acute oral LD50 value of the test item Reactive Orange F08-0314 was found to be above 2000 mg/kg bw in female RjHan: WI rats.
According the GHS criteria,Reactive Orange F08-0314should be ranked as "Category 5" or "Unclassified".
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.
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