Registration Dossier
Registration Dossier
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EC number: 286-386-3 | CAS number: 85223-31-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Not toxic to reproduction
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 350 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
The following data was obtained for the Similar Substance 01. It is expected that the Target substance will present comparable toxicity potential to reproduction. Justification for the use of a read-across approach is provided in Section 13 of IUCLID.
A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test was conducted to obtain information on the toxic potential of test item, following the testing method and testing procedures outlined into the OECD guideline 422.
The substance was administered to rats orally (by gavage) once daily at 0 (vehicle only), 40, 120 and 350 mg/kg bw/day doses. The concentration of the test item in the dosing formulations was checked two times during the study and the concentrations varied within the range of 97 and 103 % in comparison to the nominal values.
All animals of the parent (P) generation were dosed prior to mating (14 days) and throughout mating. In addition, males received the test item or vehicle after mating up to the day before the necropsy (altogether for 42 days). Females were additionally exposed through the gestation period and up to lactation days 14-16, i.e. up to the day before necropsy (altogether for 51-65 days).
There was no test item related mortality at any dose level. A test item influence on the oestrous cycle was not found at any dose level and there were no toxicologically significant differences between the control and test item treated male or female animals in the examined parameters of reproductive performance or in the delivery parameters of dams.
There were no toxic or other test item related lesions detectable by histological examination in the investigated reproductive organs (ovaries, uterus, vagina, testes, epididymides, prostate and seminal vesicles with coagulating gland) of male or female animals administered with 350 mg/kg bw/day.
Effects on developmental toxicity
Description of key information
No toxic to developmental
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 350 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
The following data was obtained for the Similar Substance 01. It is expected that the Target substance will present comparable developmental toxicity potential. Justification for the use of a read-across approach is provided in Section 13 of IUCLID.
A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test was conducted to obtain information on the toxic potential of test item, following the testing method and testing procedures outlined into the OECD guideline 422.
The substance was administered to rats orally (by gavage) once daily at 0 (vehicle only), 40, 120 and 350 mg/kg bw/day doses. The concentration of the test item in the dosing formulations was checked two times during the study and the concentrations varied within the range of 97 and 103 % in comparison to the nominal values.
All animals of the parent (P) generation were dosed prior to mating (14 days) and throughout mating. In addition, males received the test item or vehicle after mating up to the day before the necropsy (altogether for 42 days). Females were additionally exposed through the gestation period and up to lactation days 14-16, i.e. up to the day before necropsy (altogether for 51-65 days).
There was no test item related mortality at any dose level.
There were no test item related changes in the serum thyroid hormone (T4 and TSH) levels at any dose (parental male or 13-day offspring).
There were no test item related changes in the serum thyroid hormone (T4 and TSH) levels at any dose (13-day offspring).
No adverse effect on the mortality, clinical signs, body weight development or necropsy findings were detected in the offspring terminated as scheduled. The anogenital distance (male and female) or nipple retention (male) were not affected.
Justification for classification or non-classification
According to CLP Regulation (EC) No 1272/2008, 3.7 Reproductive toxicity section, reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring.
Based on the available information, the substance does not meet the criteria to be classified for reproductive toxicity, according to CLP Regulation (EC) No 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
