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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 262-992-3 | CAS number: 61788-64-5
Endpoint summary
Administrative data
Description of key information
No data are available for the fish oil, sulphated, sodium salt
Screening studies (OECD 422) have been performed on similar substances (castor oil sulphated EC 269 -123 -7, sulfited fat liquors EC 307-037-4 fish oil and EC 281-975-1 rape oil) indicate that no effects were seen at the highest concentration tested, therefore the 'No Observed Adverse Effect Level' (NOAEL) for systemic toxicity was considered to be 300 mg/kg/day.
The analogous substance Castor oil derivative has been tested in a 90 days study (OECD 408) with the following results
NOAEL rat (90d) = 450 mg/Kg/day (test item)
NOAEL rat (90d)= 288 mg/kg/day (active substance 62 -64%))
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 288 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- 1
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Regulation EC 1272/2008 regarding classification criteria for substances (Annex I, table 3.9.1) states that "Substances are classified in category 2 for target organ toxicity (repeated exposure) on the basis of observations from appropriate studies in experimental animals in which significant toxic effects, of relevance to human health, were produced at generally moderate exposure concentrations".
Moreover, at paragraph 3.9.2.9.2 it reads:" In order to help reach a decision about whether a substance shall be classified or not, and to what degree it shall be classified, dose/concentration ‘guidance values’ are provided for consideration of the dose/concentration which has been shown to produce significant health effects.
Repeated-dose studies conducted in experimental animals are designed to produce toxicity at the highest dose used in order to optimise the test objective and so most studies will reveal some toxic effect at least at this highest dose. What is therefore to be decided is not only what effects have been produced, but also at what dose/concentration they were produced and how relevant is that for humans".
These "guidance values" are provided in table 3.9.3, and refers to effects observed in a standard 90 day repeated dose study in which classification is not applicable when "significant toxic effects" are detected over a dose of 100 mg/kg/day.
Based on the results of the 90day on the test item, the substance is not classified for repeated dose oral toxicity
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.
