Registration Dossier
Registration Dossier
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EC number: 406-370-3 | CAS number: 58890-25-8 MDI/CHA
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
An oral OECD 421 screening study was performed with the source substance Thickener (MDI-CHA-ODA). The parental and reproduction NOAEL was determined to be ≥1000 mg/kg bw/day.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The study was performed according to OECD and/or EC guidelines and according to GLP principles (Klimisch 1).
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Assessment of reproductive oral toxicity of the source substance Thickener (MDI-CHA-ODA) was performed in Wistar rats according to OECD/EC guidelines and GLP principles. Thickener (MDI-CHA-ODA) was administered by daily oral gavage at dose levels of 100, 300 and 1000 mg/kg bw/day. The rats of the control group received the vehicle, corn oil, alone. Males were treated for for two weeks prior to mating, during mating, and up to termination (29-37 days), females that delivered offspring were treated for 2 weeks prior to mating, during mating, during post-coitum and at least 13-15 days of lactation (50-68 days) and females that failed to deliver pups were treated for 42-55 days.
No parental toxicity was observed up to the highest dose level tested (1000 mg/kg bw/day). No treatment-related changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, body weight, food consumption, male T4 thyroid hormone levels, macroscopic examination, organ weights, and microscopic examination).
No reproduction toxicity was observed up to the highest dose level tested (1000 mg/kg bw/day). No treatment-related changes were noted in any of the reproductive parameters investigated in this study (i.e. mating and fertility indices, precoital time, number of implantations, estrous cycle, spermatogenic profiling, and histopathological examination of reproductive organs).
No developmental toxicity was observed up to the highest dose level tested (1000 mg/kg bw/day). No treatment-related changes were noted in any of the Developmental parameters investigated in this study (i.e. gestation, viability and lactation indices, duration of gestation, parturition, sex ratio, maternal care, litter size and early postnatal pup development consisting of mortality, clinical signs, body weight, anogenital distance, areola/nipple retention, T4 thyroid hormone levels and macroscopic examination).
In conclusion, as no adverse effects were observed in this study up to and including the highest dose tested, the parental NOAEL as well as the NOAEL for reproduction effects were concluded to be at least 1000 mg/kg bw/day.
Effects on developmental toxicity
Description of key information
An oral OECD 421 screening study was performed with the source substance Thickener (MDI-CHA-ODA). The parental and developmental NOAEL was determined to be ≥1000 mg/kg bw/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The study has been performed according to OECD and/or EC guidelines and according to GLP principles (Klimisch 1).
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
See discussion above on effects on reproduction.
Justification for classification or non-classification
Based on the available study, the substance does not have to be classified for reproductive and/or developmental toxicity according to CLP Regulation EC (No.) 1272/2008 (including all amendments).
Additional information
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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