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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 223-861-6 | CAS number: 4098-71-9
Toxicity to reproduction
Administrative data
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- According to section 1.2 of Annex XI, reproductive toxicity/fertility testing, i.e. Screening study (Annex VIII, Section 8.7.1.; OECD TG 421) and Extended One-Generation Reproductive Toxicity study (Annex X, Section 8.7.3.; test method: EU 8.56./OECD TG 443) need not be done if there is a weight-of-evidence to conclude the substance does not have a particular property, and further testing on vertebrate animals may be omitted. The toxicological database for inhaled 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (IPDI) demonstrates consistently that toxicity is associated only with the portal of entry (respiratory tract), any other manifestations of toxicity are secondary to this. Additionally, a study according to OECD TG 414 with rats (1st species) is available as well as other repeated dose studies (OECD TG 413, 412) and acute toxicity studies (OECD TG 403, 401) on IPDI showing all toxicity confined to the respiratory tract. In the developmental toxicity study, effects on fetal development were only observed in presence of maternal toxicity and induced by secondary systemic effects such as hypoxia. Furthermore, the information gained in developmental and reproductive toxicity studies of other aliphatic diisocyanates, i.e. HDI and H12MDI confirmed the local mode of action for the entire substance group of diisocyanates. Protection against respiratory tract toxicity will protect against any secondary effects. A full and detailed justification elaborating this data waiver is attached to this record. By weight-of-evidence, it is concluded that reproductive toxicity is not an endpoint of concern for IPDI and additional toxicity testing is not necessary.
Data source
Materials and methods
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
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.
