Registration Dossier
Registration Dossier
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EC number: 207-431-5 | CAS number: 470-82-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 600 mg/kg bw/day
Additional information
A study was performed to screen for potential adverse effects of the test item on reproduction including offspring development and provides an initial hazard assessment for effect on reproduction. The study is compatible with the requirements of the recommendations of the OECD Guidelines for Testing of Chemicals No. 421. The No Observed Adverse Effect Level (NOAEL) for adult toxicity, reproduction and offspring survival, growth and development was considered to be 600 mg/kg bw/day.
Short description of key information:
A study was performed to screen for potential adverse effects of the test item on reproduction including offspring development and provides an initial hazard assessment for effect on reproduction. The study is compatible with the requirements of the recommendations of the OECD Guidelines for Testing of Chemicals No. 421.
The No Observed Adverse Effect Level (NOAEL) for adult toxicity, reproduction and offspring survival, growth and development was considered to be 600 mg/kg bw/day.
Justification for selection of Effect on fertility via oral route:
The No Observed Adverse Effect Level (NOAEL) for adult toxicity, reproduction and offspring survival, growth and development was considered to be 600 mg/kg bw/day.
Effects on developmental toxicity
Description of key information
The results of a screening study on testes toxicity on the structural analogue Pyranol are provided as part of a weight of evidence. At 1000 mg/kg body weight/day salivation after treatment was observed in all animals. Neither sperm evaluation nor gross and histopathology of male sexual organs revealed treatment-related findings. Pyranol caused slight systemic toxicity but no treatment-related adverse effects regarding the male reproductive organs were observed.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
The results of a screening study on testes toxicity on the structural analogue Pyranol are provided as part of a weight of evidence. At 1000 mg/kg body weight/day salivation after treatment was observed in all animals. Neither sperm evaluation nor gross and histopathology of male sexual organs revealed treatment-related findings. Pyranol caused slight systemic toxicity but no treatment-related adverse effects regarding the male reproductive organs were observed.
To address toxicological endpoints as part of the REACH registration of Cineole (Target Substance) it is proposed to read-across to Pyranol (Source Substance).
The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible.
The Target Substance and Source Substance have been characterised in using the categories and databases present in the OECD (Q)SAR Toolbox. From the profiling in this table, it can be seen that the two substances share structural similarities and also "mechanistic action" similarities which are both general and endpoint specific.
Therefore read-across is justified.
Justification for selection of Effect on developmental toxicity: via oral route:
The results of a screening study on testes toxicity on the structural analogue Pyranol are provided as part of a weight of evidence. At 1000 mg/kg body weight/day salivation after treatment was observed in all animals. Neither sperm evaluation nor gross and histopathology of male sexual organs revealed treatment-related findings. Pyranol caused slight systemic toxicity but no treatment-related adverse effects regarding the male reproductive organs were observed.
Justification for classification or non-classification
According to Directive 67/548/EEC and Regulation (EC) 1272/2008, no classification is warranted.
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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