Registration Dossier
Registration Dossier
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EC number: 402-860-6 | CAS number: 110553-27-0 CG 25-1320; IRGANOX 1520; TK 12229/1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP (taken from SNIF file). Registrant refering to studies >12 years old at the permission of ECHA.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,6-bis(octylthiomethyl)-o-cresol
- EC Number:
- 402-860-6
- EC Name:
- 4,6-bis(octylthiomethyl)-o-cresol
- Cas Number:
- 110553-27-0
- Molecular formula:
- C25H44OS2
- IUPAC Name:
- 4,6-bis(octylthiomethyl)-o-cresol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino Rats Tif: RAIf (SPF), hibrids of Rll
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water containing 0.5% CMC and 0.1% Tween 80
- Details on oral exposure:
- Method of administration: orally by gavage
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 10 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 250 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 10 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day - Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- minimal higher activity of alkaline phosphatase in the male of group 4 (250 mg/Kg) and male and females of the high dose group (1000 mg/Kg)
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- lightly increased liver weights was observed in treated males group 4 and 5 (250 + 1000 mg/Kg) and in females group 5
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Clinical observations:
No clinical symptoms related to the administration of the test article and no signs of systemic toxicity were observed during the study
Laboratory findings:
The finding in treated groups were unremarkable and comparable to those of the controls.
The investigations revealed a minimal higher activity of alkaline phosphatase in the male of group 4 (250 mg/Kg) and
male and females of the high dose group (1000 mg/Kg)
Effects in organs:
- Eye examinations performed before and towards the end of the treatment period revealed no evidence of reaction to the treatment.
- A trend to slightly increased liver weights was observed in treated males group 4 and 5 (250 + 1000 mg/Kg) and in females group 5.
- Macroscopical and microscopical examination revealed no changes which could be attributed to effects of the test compound.
No toxic effect level: 50 mg/Kg body weight
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day
- Dose descriptor:
- NOEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified
- Executive summary:
Classified as: Not classified
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