Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 256-783-6 | CAS number: 50814-31-8 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 40215.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Source study has reliability 2. Details on the read across are attached in section13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Qualifier:
- according to guideline
- Guideline:
- other: WHO/VBC 88.953
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: TIf: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Weight at study initiation: 177 to 206 g
- Fasting period before study: overnight
- Housing: in Macrolon cages type 4, with standardized soft wood beeding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Air changes: 15 per h
- Photoperiod: 12 h /day light cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Single oral dose, by gastric intubation (gavage)
Vehicle: distilled water
Amount of vehicle: 10 ml/kg bw - Doses:
- 2000 mg/kg (males and females)
Volume applied: 10 ml/kg bw - No. of animals per sex per dose:
- 5 males and 5 females (total number of animals: 10)
- Control animals:
- yes
- Details on study design:
- Observations and records
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days.
Signs and symptoms: daily for 14 days.
Body weight: immediately before administration and on days 7 and 14.
Necropsies: animals submitted to a gross necropsy at the end of the observation period.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occurred.
- Clinical signs:
- other: Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. Additionally, diarrhea was observed in females. Animals recovered within 5 days.
- Gross pathology:
- At necropsy, a spotted thymus was found in one female. No deviations from normal morphology were found in the remaining animals.
Any other information on results incl. tables
| dose (mg/kg) | number of animals | number of deaths | |
| males | 2000 | 5 | 0 |
| famales | 2000 | 5 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- The substance was tested according to the guidelines OECD 401.
Upon an acute oral administration and a 14 day post-treatment observation period in rats of both sexes, no mortality was recorded. Therefore, in male and female rats:
LD0 = 2000 mg/kg
LD50 > 2000 mg/kg - Executive summary:
Method
Acute oral toxicity to rats was assessed in a limit test. A single dose of 2000 mg/kg was given by gavage to 10 young adult rats (5 males and 5 females Tif: Rai f). Rats were obserevd daily for 14 days after dosing. Mortality, signs and symptoms were recorded daily; body weight was measured immediately before administration and on days 7 and 14; necropsy was done at the end of the observation period.
Results
No mortality was seen during the 14 -days observation period, thus LD0 = 2000 mg/kg and LD50 > 2000 mg/kg.
Clinical signs as piloerection, dyspnea, hunched posture and diarrhea were recorded.
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.
