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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxic effect type:
dose-dependent

Effects on fertility

Description of key information

No data are available for fish oil, sulphated sodium salt.

Read across from similar substances (sulfited fat liquors EC 307-037-4 fish oil and EC 281-975-1 rape oil) indicate no treatment-related effects for reproduction based on OECD 422 test. The ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 1000 mg/kg/day, the highest dose tested.

Moreover, the analogue substance EC 269 -123 -7 Castor oil sulfated sodijm salt has been tested for reproductive toxicity in a combined study on reproducrive toxicity and repeated dose according to OECD 422 and in a developmental study OECD 414. No reproduction or developmental toxicity was observed up to the highest dose level tested (1000 mg/kg).

NOAEL (repro) = 1000 mg/kg/day (test item)

NOAEL (repro) = 640 mg/kg / day (active ingredient, 62 -64% wt)

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
640 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

Effects on developmental toxicity

Description of key information

NOAEL (developmental) = 1000 mg/kg/day (test item)

NOAEL (developmental) = 640 mg/kg/day (active ingredient, 62 -64% wt)

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
640 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

Justification for classification or non-classification

Reproductive toxicity includes adverse effects on sexual function and fertility in sexually adult males and females animals, as well as developmental toxicity in the offspring. However, developmental toxicity essentially means all the adverse effects induced during pregnancy that can be manifested at any point of the life span of the animal, which might in turn bring to structural abnormality, altered growth and/or organs development, functional deficiency, even death.

Table 3.7.1(a) of Annex I of EC Regulation 1272/2008 states that to classify compounds "for category 2 suspected human reproductive toxicant, reproductive effects shall have been observed in the absence of other toxic effects, or if occurring together with other toxic effects the adverse effect on reproduction is considered not to be a secondary non-specific consequence of the other toxic effects". To this extent the screening study performed on the substance does not provide any indication of direct adverse effect on reproduction. In fact up to the dose of 1000 mg/kg bw/day (test item), 640 mg/kg /day (active ingredient) no effects were observed in both genders on reproduction, nor parental toxicity was detected. Moreover, no developmental toxic effects in the offspring were observed at all doses.

In conclusion, since no adverse effects on reproduction were observed, classification for reproductive/developmental toxicity is not warranted under Regulation 1272/2008.

 

Additional information