Registration Dossier
Registration Dossier
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EC number: 248-471-3 | CAS number: 27458-94-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986.05.05 - 1986.05.21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented study essentially equivalent to standard test guidelines, although not to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Isononyl alcohol
- EC Number:
- 248-471-3
- EC Name:
- Isononyl alcohol
- Cas Number:
- 27458-94-2
- Molecular formula:
- C9H20O
- IUPAC Name:
- 3,5,5-trimethylhexan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Isononanol (C9 branched and linear)
- Physical state: liquid
- Analytical purity: > 99%
- Sample-No.: 3635-81058
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Ratte, Bor: WISW (SPF TNO)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, 4799 Borchen
- Weight at study initiation: 116-119 g
- Fasting period before study: 16 hours
- Housing: 1 - 5 animals in "Makrolonkäfig" Type III
- Diet (e.g. ad libitum): R10 Alleindiät für Ratten, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 4 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +- 1°C
- Humidity (%): 60% +-5%
- Air changes (per hr): 15 times/ hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Single admistration by oral gavage (volume: 3.792-6.012 cm³/kg)
- Doses:
- 3160 mg/kg, 3980 mg/kg and 5010 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females per dose.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Bodyweight: The animals were weighed before treatment and after 1, 7, and 14 days.
- Necropsy of survivors performed: yes - Statistics:
- An LD50 was determined according to Litchfield and Wilcoxon including 95% confidence limits (J.Pharmacol. Exp. Ther. 96, 1949,99).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 950 mg/kg bw
- Mortality:
- 3160 mg/kg: 1/5 males and 1/5 females
3980 mg/kg: 1/5 males and 3/5 females
5010 mg/kg: 5/5 males and 4/5 females - Clinical signs:
- other: 30 minutes after treatment, the animals showed ruffled fur, crouched posture, light tremor, temporary light sedation and ataxia with face-down position. Later, the following symptoms were also observed: decelerated and uncontrolled action, breathing diffi
- Gross pathology:
- Die Sektion am Versuchsende ergaben bei je 2 Tieren partielle Hyperämien der Dünndarmschleimhäute und herdförmige Verdickungen auf den Vormagenschleimhäuten. Eines dieser Tiere hatte außerdem eine hyperämische Magenschleimhaut.
Post mortem wurden bei den Sektionen Hyperämien der Magen- und Darmschleimhäute, hell gefleckte Lebern und bei einem Tier auch eine Hyperämie der Blasenschleimhaut festgestellt.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
Isononanol (undiluted) was administered by oral gavage to three groups of 5 male and 5 female rats at dosages of 3160, 3980 or 5010 mg/kg. Shortly after administration, the animals showed ruffled fur, crouched posture, light tremor, temporary light sedation and ataxia with face-down position, followed by decelerated and uncontrolled action, breathing difficulties, semi-closed eyes, diarrhoea, hypothermia and lateral position. Deaths ocurred at all treatment levels. Symptoms were not apparent in surviving animals after Day 3 of the observation period, and bodyweights on Days 7 and 14 were unaffected. Necropsy findings were unremarkable.
The acute oral median lethal dossage (LD50 combined sexes) for Isononanol in rats was 3950 (confidence interval 3527-4424) mg/kg
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