Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 635-476-4 | CAS number: 88349-88-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No reproductive or developmental effects were observed in the dietary reproduction/developmental toxicity screening test at doses up to 2100 ppm (equivalent to 123 mg/kg/day for males and 125 mg/kg/day for females during pre-breeding and 143 mg/kg/day for females during the gestation and 227 mg/kg/day for females during lactation). The substance is not therefore predicted to be a reproductive toxicant.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 123 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Klimisch score = 1. Modern study compliant with current test guidelines and GLP
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
A screening study (Ellis-Hutchings et al, 2014) was conducted according to OECD test guideline 421 to evaluate the potential effects of cloquintocet acid (administered in the diet) on reproductive function, prenatal/neonatal survival and growth of the offspring. During the premating, gestation, and lactation phases of the study, there were no treatment-related effects in clinical observations, body weight and body weight gain, feed consumption, reproductive function, prenatal/early neonatal growth and survival of the offspring, organ weights, or gross pathology in either sex at all dose levels tested. Females given 2100 ppm of cloquintocet acid had very slight periportal hepatocyte vacuolization consistent with fatty change. Due to the minimal nature of this change and absence of any other degenerative, inflammatory or necrotic changes in the liver, it was interpreted to be a non-adverse effect. Based on these results, the no-observed-adverse-effect level (NOAEL) for general toxicity was 2100 ppm. The no-observed-effect level (NOEL) for reproductive effects was 2100 ppm, the highest concentration tested.
Effects on developmental toxicity
Description of key information
The findings from the 90-day repeated dose oral toxicity study (OECD Test Guideline 408) and the reproductive/developmental toxicity screening test (OECD Test Guideline 421) study on cloquintocet acid provide a characterisation of the reproductive toxicity hazard of the substance.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
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
No study is available for effects on developmental toxicity; however a study is not considered necessary because no adverse effects on reproductive organs or tissues were reported in the 90-day repeat dose oral toxicity study (Sura et al, 2014a) and no relevant effects were seen in the reproductive/developmental toxicity screening study (Ellis -Hutchings et al, 2014). The findings from the 90-day repeated dose oral toxicity study (OECD Test Guideline 408) and the reproductive/developmental toxicity screening test (OECD Test Guideline 421) study on cloquintocet acid provide a characterisation of the reproductive toxicity hazard of the substance.
Toxicity to reproduction: other studies
Description of key information
No other studies available.
Additional information
No further studies are required because no adverse effects on reproductive organs or tissues were reported in the 90-day study and no relevant effects were seen in the reproductive/developmental toxicity screening study.
Justification for classification or non-classification
The results of a reproductive/developmental screening study on cloquintocet acid do not indicate that the substance is a reproductive or developmental toxicant. The substance does not meet the criteria for classification for developmental or reproductive toxicity according to according to the CLP Regulation 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.
