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Registration Dossier
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EC number: 607-985-1 | CAS number: 26678-02-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-02-20 to 2003-03-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (1996)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (1996)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- (1996)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Copolymer of hexanedioic acid and 1,5-pentanediol
- EC Number:
- 607-985-1
- Cas Number:
- 26678-02-4
- Molecular formula:
- Exact identification is not feasible
- IUPAC Name:
- Copolymer of hexanedioic acid and 1,5-pentanediol
- Details on test material:
- Oligo-PAP of Degussa AG
Batch No. 02 005, manufactured 03 May 2002
Sample No. 1923/020909
Sample ID 0649/82229
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Source: WISTAR strain Crl: (EI) BR , Charles River Deutschland, Sulzfeld
- Weight at study initiation: 174 - 281 g, young adult animals
- Fasting period before study: maximum 20 hours
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 21 °C +/- 3° C
- Humidity (%): 30 % - 70 %
- Air changes (per hr): 15 times
- Illumination: 12 hours artifical fluorescent light and 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- ADMINISTRATION:
- Frequency: single dosage on day 1
- Dose: 2000 mg/kg/bw (1.94 ml/kg), undiluted
- Dose volume was calculated as dose level: density - Doses:
- 2000 mg/kg
- 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: periodic intervals on the dayof dosing (day 1) and once daily thereafter, until day 15
- Body weight: days 1 (pre-administration) 8 and 15
- Necropsy: All survived animals were necropsied at the end of the observation period - Statistics:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortalitiy occurred.
- Clinical signs:
- Hunched posture was noted in all males on day 1. Hunched posture, lethargy uncoordinated movements and piloerection was noted among the
females. The animals had recovered from the symptoms between days 1 and 5. - Body weight:
- No apparent changes were found in body weight.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- no other findings
Any other information on results incl. tables
no other information
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- The oral LD50 value of OLIGO-PAP in Wistar rats was established to exceed 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity study of OLIGO-PAP was determined with 3 male and 3 female WISTAR rats. Both male and female rats were treated with 2000 mg/kg bw. Animals were observed for symptoms of clinical toxicity and mortality for 14 days after treatment. Hunched posture was noted in all males on day 1. Hunched posture, lethargy uncoordinated movements and piloerection was noted among the females. The animals had recovered from the symptoms between days 1 and 5. No mortality occured, no apparent changes were found in body weight and necropsy. Therefor the oral LD50 value of OLIGO-PAP in Wistar rats was established to exceed 2000 mg/kg bw. OLIGO-PAP does not have to be classified and has no obligatory labelling requirement for oral toxicity.
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