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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
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- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
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- Toxicological Summary
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- Acute Toxicity
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- Repeated dose toxicity
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- Carcinogenicity
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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 October 2010 - 20 October 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to EU, OECD & US EPA test standards 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:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- Substance Name: Reactive Blue F08-0170
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar RjHan:WI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test Animals
Species and strain: RjHan:(WI) Wistar rats
Source: Laboratoire Elevage Janvier, B.P. 4105, Route des Chênes Secs, 53940 Le Genest-St-Isle CEDEX FRANCE
Hygienic level at arrival: SPF
Hygienic level during the study: Standard housing conditions
Justification of strain: The Wistar rat is one of the standard rodent species used in acute toxicity studies
Number of animals: 5 animals/sex
Sex: Male and female, female rats were nulliparous and non-pregnant.
Age of animals at study start: Young adult rats
Body weight range at dosing: Between 210 g and 250 g
Acclimatization time: 6 days
Husbandry
Animal health: Only healthy animals were used for the study. The veterinarian certified the health status.
Room-Box: 242/1
Housing: Individual caging
Cage type: Type II. polypropylene/polycarbonate
Bedding: Laboratory bedding: Lignocel Hygienic Animal Bedding produced by J. Rettenmaier & Söhne GmbH+Co.KG (Holzmühle 1, 73494 Rosenberger, Germany); A copy of the relevant Certificate of Analysis is maintained in LAB Research Ltd.'s archive.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20.4- 24.9 °C
Relative humidity: 31 - 62 %
Ventilation: 15-20 air exchanges/hour
Enrichment: Rodents were housed with deep wood sawdust bedding to allow digging and other normal rodent activities.
The temperature and relative humidity was recorded twice daily during the study.
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 not considered to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
Water quality control analysis is performed once every three months and microbiological assessment is performed monthly, by Veszprém County Institute of State Public Health and Medical Officer Service (ÁNTSZ, H-8201 Veszprém, József A.u.36., Hungary). The quality control results are retained in the archives at LAB Research Ltd.
Identification
The individual identification was performed using numbers written on the tail with a 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 containing information about study code, sex, dose group, cage number and individual animal numbers.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- The back of each animal was shaved (approximately 10 % area of the total body surface) approximately 24 hours prior to treatment. The test item was applied as a single dose as supplied to the shaved skin and remained in contact with the skin for the 24- hour exposure period. For that purpose, the appropriate amount of the test item was moistened with distilled water and distributed as uniformly as possible. Sterile gauze pads were placed on the skin of rats to cover the test item. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours.
At the end of the exposure period, the area of skin treated with the test item was washed with water of body temperature. - Duration of exposure:
- 24 hours
- Doses:
- The test item was not expected to be lethal at 2000 mg/kg bw. A limit test was therefore performed.
- No. of animals per sex per dose:
- 5 males/5 females per dose
- Control animals:
- no
- Details on study design:
- Clinical Observations
Clinical observations were performed on the day of treatment at 1 and 5 hours after application of the test item and once each day for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, the 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.
Measurement of Body Weight
The body weights were recorded on Day 0 (before test item administration) and on Days 3, 7 and 14.
Necropsy
All animals were anaesthetised with Euthasol 40% and exsanguinated. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All macroscopic changes were recorded. - Statistics:
- None
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No effects.
- Mortality:
- No mortality occurred after a 24-hour dermal exposure of REACTIVE BLUE F08-0170 administered at 2000 mg/kg bw to RjHan:(WI) Wistar rats followed by a 14-day observation period.
- Clinical signs:
- other: No clinical signs were observed after the treatment with the test item or during the 14 day observation period.
- Gross pathology:
- The single oral gavage of Reactive Blue F08-0170 at a dose level of 2000 mg/kg bw, was not associated with any test item-related gross findings.
- Other findings:
- Bluish staining was recorded on the skin in all animals after dosing. The discoloration of the skin lasted 1 day in male and up to 7 days in female rats. No other local dermal signs were observed.
Any other information on results incl. tables
INDIVIDUAL CLINICAL OBSERVATIONS STUDY CODE: 10/252-002P TEST SYSTEM: Rj Han: WI Rat TEST ITEM: Reactive Blue F08-0170
Dose Level: 2000mg/kg
Sex: Male
Cage No.
|
Animal No.
|
Observations |
Observation days |
Frequency |
|||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||
1 |
2189 |
Symptom Free |
+ |
+ |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
15/16 |
|
|
Skin (Bluish) |
- |
- |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1/16 |
2 |
2190 |
Symptom Free |
+ |
+ |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
15/16 |
|
|
Skin (Bluish) |
- |
- |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1/16 |
3 |
2191 |
Symptom Free |
+ |
+ |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
15/16 |
|
|
Skin (Bluish) |
- |
- |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1/16 |
4 |
2192 |
Symptom Free |
+ |
+ |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
15/16 |
|
|
Skin (Bluish) |
- |
- |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1/16 |
5 |
2193 |
Symptom Free |
+ |
+ |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
15/16 |
|
|
Skin (Bluish) |
- |
- |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1/16 |
Dose Level: 2000mg/kg
Sex: Female
Cage No.
|
Animal No.
|
Observations
|
Observation days |
Frequency
|
|||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||
6 |
2194 |
Symptom Free |
+ |
+ |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
12/16 |
|
|
Skin (Bluish) |
- |
- |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
4/16 |
7 |
2195 |
Symptom Free |
+ |
+ |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
12/16 |
|
|
Skin (Bluish) |
- |
- |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
4/16 |
8 |
2196 |
Symptom Free |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
9/16 |
|
|
Skin (Bluish) |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
7/16 |
9 |
2197 |
Symptom Free |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
9/16 |
|
|
Skin (Bluish) |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
7/16 |
10 |
2198 |
Symptom Free |
+ |
+ |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
13/16 |
|
|
Skin (Bluish) |
- |
- |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
3/16 |
Remarks: +: present absent
h=hour (s) Treatment day= Day 0
Frequency of observation = number of occurence of observation / total number of observations
Applicant's summary and conclusion
- 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 REACTIVE BLUE F08-0170 was found to be higher than 2000 mg/kg body weight in male and female RjHan:(WI) Wistar rats. The substance is not classified.
- Executive summary:
An acute dermal toxicity study was performed with test item REACTIVE BLUE F08-in RjHan:(WI) Wistar rats, in compliance with OECD Guideline No.: 402.
A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied, moistened with distilled water, as a single dermal 24-hour exposure followed by a 14‑day observation period.
Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 3, 7 and 14. Rats were euthanized and a gross macroscopic examination performed at the end of the 2-week observation period (Day 14).
The results of the study were summarized as follows:
Mortality
No mortality occurred.
Systemic clinical signs
No clinical signs were observed after the treatment with the test item or during the 14‑day observation period.
Local dermal signs
No local dermal signs were observed during the entire study period. However, bluish staining was observed on the skin in all animals after dosing from Day 1 to Day 7.
Body weight
The body weight and body weight gain of REACTIVE BLUE F08-0170 treated animals did not show any test item-related effect.
Necropsy
There was no evidence of Reactive Blue F08-0170-related findings at necropsy. Uterus in estrus was observed in one female 2196.
The substance is not classified as harmful by dermal exposure.
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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