Registration Dossier
Registration Dossier
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EC number: 605-301-6 | CAS number: 162691-59-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to EEC Directive 92/96, B.1. Study conducted under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- Method: other: EEC Directive 92/69. B.1.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- ASTA-C15-ACETAL (C15-ACL)
- IUPAC Name:
- ASTA-C15-ACETAL (C15-ACL)
- Reference substance name:
- 94/29
- IUPAC Name:
- 94/29
- Details on test material:
- - NAME OF TEST SUBSTANCE: ASTA-C15-ACETAL (C15-ACL)
- SUBSTANCE NUMBER: 94/29
- LOT NUMBER: 25656/133 S
- DATE OF MANUFACTURING: 07-FEB-1994
- PHYSICAL STATE/APPEARANCE: LIQUID, OILY, YELLOW
- STORAGE CONDITIONS: ROOM TEMPERATURE, EXCLUSION OF LIGHT
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: olive oil DAB 10
- Doses:
- 2,000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weights determined shortly before application, weekly thereafter and at the end of the study. Recording of clinical signs several times on day of administration, at least once each workday for the individual animals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights,
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortality observed.
- Clinical signs:
- No sympthoms were recorded for female animals.
Male animals suffered from impaired general state, poor general state, dyspnoea, apathy, staggering, twitching, piloerection, smeared fur, red adhesive snout and compulsary gnawing. All sympthomes disappeared within the firt 3 days after administration. - Body weight:
- Mean body weight of male animals [g] before/7/13 days after application: 171/224/263
Mean body weight of female animals [g] before/7/13 days after application: 180/207/219 - Gross pathology:
- No pathologic findings noted in any of the test animals.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, the test substance Asta-C15-acetal (C15-ACL) does not need to be classified according to Regulation (EC) No. 1272/2008 and EU Directive 67/548/EEC.
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