Registration Dossier
Registration Dossier
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EC number: 402-070-1 | CAS number: 88122-99-0 UVINUL T 150
Endpoint summary
Administrative data
Description of key information
NOEL=1 000 mg/kg bw/day (nominal)
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Rat/ Mouse and haster diet 343
- Details on oral exposure:
- Method of administration: in the diet
- Duration of treatment / exposure:
- Test duration: 90 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 10 animals at 0 mg/kg bw/day
Male: 10 animals at 1000 mg/kg bw/day
Male: 10 animals at 4000 mg/kg bw/day
Male: 10 animals at 16000 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 10 animals at 1000 mg/kg bw/day
Female: 10 animals at 4000 mg/kg bw/day
Female: 10 animals at 16000 mg/kg bw/day - Details on results:
- Clinical observations: o.B., no abnormalities noted
Laboratory findings: findings were not considered to be treatment related
Effects in organs: no treatment related effects - Dose descriptor:
- NOAEL
- Effect level:
- <= 1 275 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Remarks on result:
- other: not further specified
- Critical effects observed:
- not specified
- Conclusions:
- Classified as: Not classified
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 408 (1987)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Method of administration : food
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Test duration : 90 days
- Frequency of treatment:
- Dosing regime : 7 days/week
- Details on results:
- Clinical observations : No premature mortalities occurred. Clinically, laboratory-diagnostically and
pathomorphologically, no substance related pathological changes could be observed.
Laboratory findings : Slight variations in the haematological and clinico-chemical parameters co
rresponded to the range of biological variaton in the species.
Effects in organs : Liver weight increases without histological correlates among treated female a
nimals could not be interpreted as being substance related. - Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- not specified
- Basis for effect level:
- other:
- Remarks on result:
- other: not further specified
- Critical effects observed:
- not specified
- Conclusions:
- not classified
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 275 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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