Registration Dossier
Registration Dossier
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EC number: 253-211-7 | CAS number: 36788-39-3
Endpoint summary
Administrative data
Description of key information
Guideline OECD 422 oral study in rats
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 100 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- System:
- male reproductive system
- Organ:
- testes
Additional information
The test item was administered by gavage to three groups, each of twelve male and twelve female Wistar Han™:RccHan™:WIST strain rats, for approximately six weeks (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 100, 300 and 1000 mg/kg bw/day. A control group of twelve males and twelve females was dosed with vehicle alone (Polyethylene glycol 400) over the same treatment period and at the same dosage volume. At 1000 mg/kg bw/day there was a clear effect on fertility leading to only a single pregnancy which appeared to be attributable to treatment-related effects on the testes and epididymides. Although pregnancy rate was satisfactory at lower dosages, treatment-related effects were apparent for the testes and epididymides at 300 mg/kg bw/day and the testes at 100 mg/kg bw/day.
A No Observed Adverse Effect Level (NOAEL) for male testicular effects could not therefore be established.
For females, there were no findings apparent at 300 mg/kg bw/day that were considered to preclude this dosage from being a NOAEL for systemic toxicity or for reproduction.
Justification for classification or non-classification
In a Guideline OECD 422 screening study, at 1000 mg/kg bw/day there was a clear effect on fertility leading to only a single pregnancy which appeared to be attributable to treatment-related effects on the testes and epididymides. Although pregnancy rate was satisfactory at lower dosages, treatment-related effects were apparent for the testes and epididymides at 300 mg/kg bw/day and the testes at 100 mg/kg bw/day. A No Observed Adverse Effect Level (NOAEL) for male testicular effects could not therefore be established.
For females, there were no findings apparent at 300 mg/kg bw/day that were considered to preclude this dosage from being a NOAEL for systemic toxicity or for reproduction.
Based on the finding of testicular degeneration in the OECD 422 oral study, the test item is classified in Category 2 for target organ toxicity (repeat exposure) according to the criteria described in Regulation (EC) No 1272/2008.
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