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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 610-979-1 | CAS number: 53207-58-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May. 1, 1984 to May. 29, 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): TK 13110 (CG 21-1201)
- Physical state: Solid
- Lot/batch No.: EP 1
- Purity: Pilot sample
Test animals
- Species:
- rat
- Strain:
- other: Tif:RAIt (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy Ltd. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 175 to 215 g
- Fasting period before study: Prior to dosing, animals were fasted overnight.
- Housing: Caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin).
- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: May 1, 1984 To: May 15, 1984
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water containing 0.5% carboxymethyl cellulose and 0.1% polysorbate 80
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: Not provided.
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg body weight
- Doses:
- 5000 mg/kg body weight
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality was observed daily (twice per day on working days and once on weekend days).
Body weight - recorded on days 1, 7, 14, and at death
- Necropsy of survivors performed: yes
Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.
- Other examinations performed:
Clinical signs - observed daily - Statistics:
- From the body weights, the group means and their standard deviation were calculated. Where feasible, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No deaths were observed.
- Clinical signs:
- Dyspnoea, exophthalmus, ruffled fur, and curved body position were seen in all animals, being common symptoms in acute tests. All animals recovered within 10 days. In addition, a slight tremor was observed shortly after application.
- Body weight:
- Mean body weight measurements were normal (see table in Remarks on results including tables and figures).
- Gross pathology:
- No gross lesions were found at necropsy.
Any other information on results incl. tables
| Males | Females | |||||
| Dose (mg/kg) | Day 1 | Day 7 | Day 14 | Day 1 | Day 7 | Day 14 |
| 5000 | 205(sd: 8.2) | 266 (sd: 9.6) | 320 (sd: 12.9) | 180 (sd: 6.3) | 207 (sd: 7.8) | 218 (sd: 3.8) |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 after single oral administration to rats, observed over a period of 14 days is greater than 5000 mg/kg body weight.
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.
