Registration Dossier
Registration Dossier
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EC number: 458-890-5 | CAS number: 2138848-94-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.162 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
No acute effects have been observed following exposure to S191820 and therefore no acute DNELs are required.
The only long-term test conducted on S191820 is a 28-day repeated dose oral toxicity study. Dose levels used in this study were 1000, 150 and 15 mg/kg/bw/day.
No toxicologically significant effects were seen in males at any dose and hence the NOEL for males was determined to be 1000 mg/kg/bw/day. However, toxicologically significant tubular basophilia/degeneration observed in relation to treatment was observed in female rats dosed at 1000 mg/kg/day and 150 mg/kg/day. The presence of the effect in females only suggests sex differences in toxicological response which may be the result of differences in metabolism of S191820 between the sexes or other physiological factors. Within the confines of the study the toxicological importance of these changes were considered minimal given that there was no effect on kidney weight nor any other evidence of renal dysfunction. However, they cannot be discounted for DNEL derivation, as they may represent an early indication of target organ toxicity especially since nephropathology is sometimes a consequence of repeated administration of coloured test materials and may indicate a continuing cellular response to the persistent accumulation of test material and/or its’ metabolite(s). Thus it is possible that following longer-term exposure (e.g. a 90-day study) more serious effects may be observed. As a result it has been concluded that the female NOEL from the oral 28-day study is the only dose descriptor applicable for DNEL derivation for systemic exposure. This is because it is the only dose value at which it can be assumed no adverse toxicity will occur. Dose descriptors for long-term dermal and inhalation exposure have been extrapolated from this oral endpoint.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.081 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 1 200
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.025 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 600
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.025 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 600
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Discussion as for workers.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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