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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Two reliable reproscreening studies with rats according to OECD 422 and under GLP conditions are available, resulting in sufficient quality to assess this endpoint.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Two key studies with regard to repeated dose toxicity are available, based on read across to Blown linseed oil and Blown rapeseed oil. Both studies were performed according to the OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), and validated with reliability 1. In both studies rats were exposed to 0, 150, 450 and 1000 mg/kg bw/day of the test substance, which had a viscosity of 1 (Blown linseed oil) and 18 Poise (Blown rapeseed oil). The tests revealed no parental toxicity up to 1000 mg/kg bw/day for both substances. Furthermore, no reproduction and developmental toxicity was observed for treatment up to 1000 mg/kg bw/day. The parental NOAEL is > 1000 mg/kg bw and the NOAEL (reproduction) and NOAEL (developmental) is >1000 mg/kg/day.

 

The results of Blown linseed oil and Blown rapeseed oil are read across to Blown castor oil. This is considered justified because 1) they share a similar composition of saturated (0 double bond) fatty acids chains, mono-unsaturated (1 double bond) and poly-unsaturated (>1 double bond) fatty acids chains. 2) The variation in chain length is not believed to affect in any way the reactivity of the raw material oil or of the finished product and by extension the toxicological behaviour of the blown oils, 3) Due to higher level of polyunsaturated fatty acid chains, Blown linseed oil presents the worst case scenario in terms of toxicology (See Category justification in Read Across document for extended explanation), 4) similar oral, dermal and inhalation absorption rates were estimated for these substances and 5) the similar physico-chemical properties. Furthermore, similar toxicity of the oils in this category was observed in the acute oral toxicity test (both LD50 > 2 mg/kg). Thus, for Blown castor oil a NOAEL of > 1000 mg/kg bw is expected for toxicity to reproduction and developmental toxicity.


Short description of key information:
Two studies with read across substances Blown linseed oil and Blown rapeseed oil, in accordance with OECD 422, showing no evidence of toxicity (NOAELparental, NOAELreproduction and NOAELdevelopmental: >1000 mg/kg bw/day).

Justification for selection of Effect on fertility via oral route:
No specific study is selected as two key studies are available from read across substance Blown linseed oil and Blown rapeseed oil.

Effects on developmental toxicity

Description of key information
Two studies with read across substances Blown linseed oil and Blown rapeseed oil, in accordance with OECD 422, showing no evidence of toxicity (NOAELparental, NOAELreproduction and NOAELdevelopmental: >1000 mg/kg bw/day).
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Two reliable reproscreening studies with rats according to OECD 422 and under GLP conditions are available, resulting in sufficient quality to assess this endpoint.
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

A summary of the OECD 422 studies with Blown linseed oil and Blown rapeseed oil, which is applicable to both toxicity to reproduction and developmental toxicity, is presented above (effects on fertility).


Justification for selection of Effect on developmental toxicity: via oral route:
No specific study is selected as two key studies are available from read across substance Blown linseed oil and Blown rapeseed oil, both summarized under toxicity to reproduction.

Justification for classification or non-classification

Based on the available information, Blown castor oil does not have to be classified for toxicity to reproduction or developemtal toxicity in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.

Additional information