Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 820-015-3 | CAS number: 129874-15-3
- 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
Acute toxicity: via oral route
The LD50 of the test material was greater than 2000 mg/kg B.W. (OECD TG401).
Acute toxicity: via dermal route
The LD50 of Everdirect SH12 was greater than 2000 mg/kg B.W. (OECD TG402).
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Range finder study only, but done to good standards and GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- The substance tested was reported as the trade name Benzanil Rubine 2BL which is Direct Red 83-1. Purity was cited at 55-60% (impurities sodium chloride and water). Although dose levels do not appear to have been adjusted for purity, the absence of findings at 2000 mg/kg means that even if adjusting for purity, the disciminating dose is > 1000 mg/kg and classification is not needed. No further animal testing is justified.
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Range-finding study
Dose level: 2000 mg/kg bw, one male and one female
Main study
Dose level: 2000 mg/kg bw, 5 males and 5 females - Control animals:
- no
- Details on study design:
- Procedure
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
Range-finding study
The animals were observed for deaths or overt signs of toxicity, ½, 1, 2 and 4 hr after dosing and subsequently once daily for 5 days.
Main study
The animals were observed for deaths or overt signs of toxicity, ½, 1, 2 and 4 hr after dosing and subsequently once daily for 14 days.
Individual bodyweights were recorded prior to dosing on Day 0 and Days 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Preliminary study:
- Range-finding study
There were no deaths or clinical signs of toxicity. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths after 14 days.
- Clinical signs:
- Noisy respiration was noted in one female up to two hours after treatment. Red stained faeces was noted in one female four hours after treatment and in all animal at the Day 1 observation. Red stained fur was commonly noted in the females at the 4 hours and Day 1 observations and persisted in one female up to the Day 4 observation.
No other clinical signs of toxicity were noted. - Body weight:
- All animals showed expected gain in bodyweight during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material, 2076 BENZANIL RUBINE 2BL, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bw.
- Executive summary:
The substance tested was reported as the trade name Benzanil Rubine 2BL which is Direct Red 83-1. Purity was cited at 55-60% (impurities sodium chloride and water). Although dose levels do not appear to have been adjusted for purity, the absence of findings at 2000 mg/kg means that even if adjusting for purity, the disciminating dose is > 1000 mg/kg and classification is not needed. No further animal testing is justified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
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:
- July 11, 2016 to December 07, 2016. 24 hour exposure.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: BioLASCO Taiwan Co. Ltd.
- Age at study initiation: about 7 weeks old
- Housing: Male and female rats were fed, respectively. Two rats per cage in an autoclaved polyethylene cage.
- Acclimation period: 7 Days
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12 hrs dark / 12 hrs light - Type of coverage:
- occlusive
- Vehicle:
- olive oil
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg B.W.
- No. of animals per sex per dose:
- For male: six
For female: six - Control animals:
- yes, concurrent vehicle
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 402 test method, the LD50 of Everdirect SH12 was greater than 2000 mg/kg B.W.. Therefore, Everdirect SH12 was Category 5 based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab for M62-151100081001EN which is based on the SOP (SOPP-342) for the OECD 402 and OECD 402 (OECD, 1987). Six male and six female Sprague-Dawley rats for each group were used in limit test. For Test group, 12Sprague-Dawley ratsweredermally dosed with 2000 mg/kg B.W. of Everdirect SH12. All animals tolerated the test article well with increasing body weights and no mortality or gross lesions findings reported. In absence of mortality or other significant clinical signs of toxicity, LD50 of Everdirect SH12 was greater than 2,000 mg/kg B.W..
Reference
Table 1. Body weight of the rats in the study period
Group |
Animal I.D. |
Dosing volume (mL) |
Body weight (g) |
Weight chenges(g) |
|
Day 1 |
Day 14 |
||||
Control |
01M |
0.6 |
284.0 |
337.7 |
+53.7 |
02M |
0.6 |
286.1 |
336.1 |
+50.0 |
|
03M |
0.6 |
289.5 |
362.1 |
+72.6 |
|
04M |
0.6 |
294.9 |
374.2 |
+79.3 |
|
05M |
0.6 |
297.6 |
360.0 |
+62.4 |
|
06M |
0.6 |
292.3 |
386.0 |
+93.7 |
|
Test |
07M |
0.6 |
284.8 |
340.0 |
+55.2 |
08M |
0.6 |
286.3 |
345.0 |
+58.7 |
|
09M |
0.6 |
291.7 |
340.0 |
+48.3 |
|
10M |
0.6 |
295.1 |
350.0 |
+54.9 |
|
11M |
0.6 |
295.5 |
340.0 |
+44.5 |
|
12M |
0.6 |
295.2 |
360.0 |
+64.8 |
|
Control |
13F |
0.4 |
206.2 |
241.7 |
+35.5 |
14F |
0.4 |
211.8 |
251.1 |
+39.3 |
|
15F |
0.4 |
216.4 |
239.4 |
+23.0 |
|
16F |
0.4 |
214.7 |
254.8 |
+40.1 |
|
17F |
0.4 |
218.1 |
267.5 |
+49.4 |
|
18F |
0.4 |
219.7 |
260.4 |
+40.7 |
|
Test |
19F |
0.4 |
211.0 |
246.3 |
+35.3 |
20F |
0.4 |
213.1 |
252.6 |
+39.5 |
|
21F |
0.4 |
214.6 |
241.1 |
+26.5 |
|
22F |
0.4 |
214.6 |
258.7 |
+44.1 |
|
23F |
0.4 |
219.2 |
265.1 |
+45.9 |
|
24F |
0.4 |
221.3 |
256.2 |
+34.9 |
Table 2. Clinical observation of the rats
Animal I.D. |
Clinical sign observation |
||||||||||||||
30 mins |
4 hours |
D2 |
D3 |
D4 |
D5 |
D6 |
D7 |
D8 |
D9 |
D10 |
D11 |
D12 |
D13 |
D14 |
|
01M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
02M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
03M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
04M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
05M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
06M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
07M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
08M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
09M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
10M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
11M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
12M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
13F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
14F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
15F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
16F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
17F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
18F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
19F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
20F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
21F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
22F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
23F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
24F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
DX: Day X in the study period
N: Normal
Table 3. Results of gross necropsy examination
Animal I.D. |
Dose |
Gross lesion |
01M |
─ |
No significant lesion founded |
02M |
No significant lesion founded |
|
03M |
No significant lesion founded |
|
04M |
No significant lesion founded |
|
05M |
No significant lesion founded |
|
06M |
No significant lesion founded |
|
07M |
2000 mg/kg B.W. |
No significant lesion founded |
08M |
No significant lesion founded |
|
09M |
No significant lesion founded |
|
10M |
No significant lesion founded |
|
11M |
No significant lesion founded |
|
12M |
No significant lesion founded |
|
13F |
─ |
No significant lesion founded |
14F |
No significant lesion founded |
|
15F |
No significant lesion founded |
|
16F |
No significant lesion founded |
|
17F |
No significant lesion founded |
|
18F |
No significant lesion founded |
|
19F |
2000 mg/kg B.W. |
No significant lesion founded |
20F |
No significant lesion founded |
|
21F |
No significant lesion founded |
|
22F |
No significant lesion founded |
|
23F |
No significant lesion founded |
|
24F |
No significant lesion founded |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute toxicity: via oral route
The study was performed to assess the acute oral toxicity of the test material, BENZANIL RUBINE 2BL, in the Sprague-Dawley CD strain rat. The test concentration was 2000 mg/kg bw, and 5 males and 5 females were tested. After 14 days, there were no deaths. No other clinical signs of toxicity were noted. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.
Acute toxicity: via dermal route
Six male and six female Sprague-Dawley rats for each group were used in limit test. For Test group, 12 Sprague-Dawley rats were dermally dosed with 2000 mg/kg B.W. of Everdirect SH12. All animals tolerated the test article well with increasing body weights and no mortality or gross lesions findings reported. In absence of mortality or other significant clinical signs of toxicity, LD50 of Everdirect SH12 was greater than 2,000 mg/kg B.W..
Justification for classification or non-classification
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.