Registration Dossier
Registration Dossier
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EC number: 473-450-2 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 April 2006 - 22 May 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- No. 338 Red
- IUPAC Name:
- No. 338 Red
- Details on test material:
- Description: red powder
Batch number: 50670
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females were given 300 mg/kg bw, 6 females were given 2000 mg/kg bw
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Female: 300 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 6; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: Il n'y a eu aucun signe de toxicité systémique quel que soit le groupe.
- Gross pathology:
- Effects on organs:
Tous les animaux ont montré des gains de poids corporel
prévus au cours de la période d'étude.
Aucune anomalie n'a été notée lors de l'autopsie quel que
soit le niveau de dosage.
Any other information on results incl. tables
No mortality was observed during the study period.
There were no signs of systemic or local toxicity.
Red-coloured staining of the faeces was noted in all animals during the study.
All animals showed expected gains in body weight over the study period.
No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 of the test material in the female rat was > 2000 mg/kg bw. The substance needs no classification for acute oral toxicity.
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