Registration Dossier
Registration Dossier
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EC number: 233-117-2 | CAS number: 10039-33-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
NOAEL (reproduction) = 25 mg/kg diet in rats, equivalent to 1.5-1.7 mg/kg bw/day in males and 1.4-2.4 mg/kg bw/day in female rats (based on effects on reproductive/developmental parameters)
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 1.4 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
For the evaluation of the reproductive toxicity of the substance data on Similar Substance 01 is used. Justification for Read Across is given in Section 13 of IUCLID.
The toxicological effect of the analogue substance on reproduction was assessed in a repeated dose toxicity and reproductive and developmental screening study in rats. The study was performed in accordance with GLP and to the standardised guideline OECD 422. Only one death was noted during the study, and this was not attributed to toxicity of the test material. Based on the effects noted in the thymus in both male and female rats in the 25 mg/kg diet groups, the NOAEL for general toxicity was concluded to be the lowest group tested, 5 mg/kg diet which was equivalent to 0.3-0.4 mg/kg bw/day for male animals and 0.3-0.5 mg/kg bw/day for female animals.
Based on effects on reproductive parameters (mean duration of gestation, post-implantation loss, total number of still born pups) the NOAEL for reproductive toxicity was determined to be 25 mg/kg diet, equivalent to 1.5-1.7 mg/kg bw/day in males and 1.4-2.4 mg/kg bw/day in female animals. All these non-specific effects are considered likely to be related to maternal toxicity (severe effects on body weight/body weight gain and food consumption during pregnancy and lactation; thymus effects).
The NOAEL deterimed is based on Similar Substance 01 doses. Readjusting to Target substance doses, considering the molecular weights of the two substances, the NOAEL is calculated as 3.3 -3.8 mg/kg bw/day (m) and 3.1 -5.3 mg/kg bw/day (f).
Effects on developmental toxicity
Description of key information
NOAEL (developmental toxicity) = 25 mg/kg diet in rats, equivalent to 1.4-2.4 mg/kg bw/day (based on pup mortality on PN 4, pup weight on PN 1 and the number of runts)
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 1.4 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
For the evaluation of the developmental toxicity of the substance data on Similar Substance 01 is used. Justification for Read Across is given in Section 13 of IUCLID.
Based on the effects noted in the thymus in the 25 mg/kg diet groups, the NOAEL for general toxicity was concluded to be the lowest group tested, 5 mg/kg diet which was equivalent to 0.3-0.5 mg/kg bw/day.
Based on post-implantation loss, total number of stillborn pups, pup mortality on PN 4, pup weight on PN 1 and the number of runts, the NOAEL for developmental toxicity was determined to be 25 mg/kg diet (equivalent to 1.4-2.4 mg/kg bw/day. All these non-specific effects are considered likely to be related to maternal toxicity (severe effects on body weight/body weight gain and food consumption during pregnancy and lactation; thymus effects)
The NOAEL deterimed is based on Similar Substance 01 doses. Readjusting to Target substance doses, considering the molecular weights of the two substances, the NOAEL is calculated as 3.1 -5.3 mg/kg bw/day (f).
Justification for classification or non-classification
In accordance with the CLP Regulation EC No. 1272/2008, on a precautionary basis, the substance is classified as Category 2: H361 Suspected of damaging fertility or the unborn child, although the non-specific effects observed on reproductive/developmental parameters (mean duration of gestation, post-implantation loss, total number of still born pups, pup mortality to PN day 4, pup weight on PN day 1 and number of runts) are likely to be related to maternal toxicity (severe effects on body weight/body weight gain and food consumption during pregnancy and lactation; thymus effects) as evidenced by the NOAEL for systemic toxicity, which is lower than the one for reproductive/ developmental toxicity, obtained in this same study.
Additional information
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