Registration Dossier
Registration Dossier
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EC number: 500-220-1 | CAS number: 68515-73-1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 110615-47-9
- EC Number:
- 600-975-8
- Cas Number:
- 110615-47-9
- IUPAC Name:
- 110615-47-9
- Details on test material:
- - Name of test material (as cited in study report): Alkylglucosid (C12/14 Kokos)
- Analytical purity: No data
- Physical state: No data
- Lot/batch No.: No data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- According to Guideline.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 250, 500, 1000 mg/kg bw
Basis:
nominal in water
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- According to Guideline.
- Positive control:
- Not necessary.
Examinations
- Observations and examinations performed and frequency:
- According to Guideline.
- Sacrifice and pathology:
- According to Guideline.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- BODY WEIGHT AND WEIGHT GAIN
The total body weight gain was slightly decreased in the weeks 1- 7 of applications in males of the groups 2 and 3 in comparison to control due to lower initial weight of the above test groups.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study)
During the administration the mean water intake was, probably compound related, slightly increased in test animals of the group 4.
GROSS PATHOLOGY
Gross section revealed ulcerations and oedema restricted to fore stomach in the group 4.
HISTOPATHOLOGY: NON-NEOPLASTIC
Histological evaluation of tissues revealed slowly reversible dose-dependent irritations and ulcerations of mucous membrane of forestonach in the groups 3 and 4. test animals of the group 2 revealed no lesions attributable to compound administration.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Inflammation and ulcerations of mucous membrane of the forestomach due to bolus administration and irritating potential of the test substance.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- According to the examinations described daily doses of 1000 mg test substance per body weight do not leed to systemic toxic effects. This dose can be classified as 'no-observable-adverse-effect-level' for rats.
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