Registration Dossier
Registration Dossier
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EC number: 429-630-8 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- liquid
- Details on test material:
- Name of test material (as cited in study report): Eldew PS-203
Physical state: pale yellow, oily liquid
Analytical purity: 100%
Purity test date: not reported
Lot/batch No.: 808010
Expiration date of the lot/batch: 31.03.2000
Storage condition of test material: test material was stored at room temperature (ca. 20°C), away from direct sunlight
Constituent 1
- Specific details on test material used for the study:
- Identification: ELDEW PS-203
Description: pale yellow liquid
Batch: 808010
Expiry date: 31.03.2000
Purity: 100 %
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 – 10 weeks
- Weight at study initiation: 174 – 212 g
- Fasting period before study: ca. 17 h
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 40 – 70 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- Application volume: 10 mL/kg bw
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 m / 3 f
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days
Examinations: clinical signs and body weight
Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality in both sexes.
- Clinical signs:
- No clinical signs were observed during the study period.
- Body weight:
- The body weight of the animals was within the range commonly recorded for animals of this strain and age.
- Gross pathology:
- No adverse effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- From a study with rats performed according to EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method) a LD50 value of > 2000 mg/kg bw was derived.
- Executive summary:
From a study with rats performed according to EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method) a LD50 value of > 2000 mg/kg bw was derived.
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.
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