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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Combined repeated dose toxicity/reproscreening study (OECD422, GLP): NOAEL reproduction 1000 mg/kg bw/d

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
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

In a combined repeated dose toxicity/reproscreening study, which was performed in accordance with OECD 422 and under GLP-conditions, Standolized linseed oil was administered by daily oral gavage to male and female Wistar Han rats at dose levels of 150, 450 and 1000 mg/kg/day. Males were exposed for 2 weeks prior to mating, during mating, and up to termination (for 29 days). The females were exposed for 2 weeks prior to mating, during mating, during post-coitum, and at least 4 days of lactation (for 42-45 days).

No chemical analyses were conducted, since no analytical method could be developed for formulations of the test substance in corn oil.

No parental toxicity attributable to treatment with Standolized linseed oil was observed at any dose level. One female at 1000 mg/kg (Group 4) had a total litter loss and was euthanized in extremis on Day 2 of the lactation period. At histopathology, severe atrophy of the lympho-hemopoeitic system was determined to be the cause of morbidity for this animal. This was considered to be spontaneous in nature. In the absence of similar findings in any other animal, it was not considered to be treatment related, and her total litter loss was considered to be secondary to the poor health of the dam.

A number of clinical biochemistry changes were noted at 450 and/or 1000 mg/kg which included higher bilirubin, creatinine and sodium levels in blood. In addition, liver to body weight ratios were increased for both sexes at 1000 mg/kg. Means of these changes only just exceeded or remained within the range considered normal for rats of this age and strain. Moreover, there were no histopathological correlates that would support these changes. Therefore, these changes were considered not to be of toxicological relevance.

Overall, no toxicologically relevant changes were noted in any of the parental parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination).

No reproductive toxicity was noted up to 1000 mg/kg. Developmental toxicity was noted that consisted of an increased number of litters with dead pups at first litter check at 1000 mg/kg and reduced body weights for pups over Days 1 and/or 4 at 1000 and 450 mg/kg, respectively.

In conclusion, treatment with standolized linseed oil by oral gavage in male and female Wistar Han rats at dose levels of 150, 450 and 1000 mg/kg body weight/day revealed no parental toxicity up to 1000 mg/kg body weight/day. Developmental toxicity was seen, characterized by an increased number of litters with dead pups at 1000 mg/kg, and reduced body weights of the pups at 450 and 1000 mg/kg. No reproduction toxicity was observed up to 1000 mg/kg/day.

Based on these results, the parental NOAEL is ≥ 1000 mg/kg/day, the reproduction NOAEL is ≥ 1000 mg/kg/day, and the developmental NOAEL is 150 mg/kg/day.


Justification for selection of Effect on fertility via oral route:
One study available which was performed according to OECD 422 and under GLP-conditions

Effects on developmental toxicity

Description of key information
Combined repeated dose toxicity/reproscreening study (OECD422, GLP): NOAEL development 150 mg/kg bw/d
Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
150 mg/kg bw/day
Study duration:
subacute
Species:
rat
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

See discussion above.


Justification for selection of Effect on developmental toxicity: via oral route:
A combined repeated dose toxicity/reproscreening study available which was performed according to OECD 422 and under GLP-conditions (summarized under toxicity to reproduction)

Justification for classification or non-classification

See attached file.

Additional information