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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

For reproduction toxicity limited data is available. Studies focus on the possible goitrogen effects of thiocyanate. A 2 generation study in which the mothers are continuously fed 25 mg KSCN/rat/day from weaning (21 days age) via the diet (25 mg/rat at weaning ~ 1000 mg/kgbw/day; at adulthood about 100 mg/kg bw/day). After 8 weeks the KSCN fed rats became hypothyroid and mating took place. Animals were kept on their respective diets throughout gestations and lactation. F1 females were kept at their mothers diets after weaning throughout subsequent pregnancy and lactation. The resulting F2 pups seemed normal and showed no differences in BW at birth or during weaning. However, T4 levels were markedly lower. Despite the relative high levels of thiocyanates, no obvious reproductive effects were observed. (Raghunath M & Bala TS, 1989, Neurochem. Int., Vol.33, pp:173-177)

 

From other studies it is probable that the compound has an adverse effect on the development the embryo: the effect on brain microtubuli formation and thyroid function occurred in conjunction with maternal effects. However, it is not possible to conclude that these effects in the offspring are specific developmental effects. Therefore, the data are insufficient to make a proposal for C&L and a specific NOAEL for developmental toxicity or reproduction toxicity cannot be derived. However, based on the available information is seems reasonable to assume that thiocyanate will not exert developmental or reproductive toxicity at levels at which thyroid function is not impacted.

 

Offspring is naturally exposed during lactation as thiocyanate is excreted by the mammary glands for a functional use as substrate for peroxidase in milk. Various reports on thiocyanate measurements in breast milk report levels of thiocyanate between 1–5 mg/L.

[http://www.jacn.org/cgi/content/full/23/2/97;Dorea JG, 2004, Maternal Thiocyanate and Thyroid Status during Breast-Feeding; J Am.Coll.Nutrit. 23(2), 97-101.]


Short description of key information:
All studies available for the aspect of reproductive toxicity are articles published in open literature. No GLP studies are available. None of the studies described in the publications is performed according to one of the OECD guidelines on reproductive toxicity (OECD 414, 415 or 416). Study design sometimes resembles those described the guidelines but none of the studies examined all the parameters requested to evaluate the effects on parents, foetuses and/or pups. Most studies focus only on the effect of thiocyanate on the thyroid function and on the development of the brain of neonates.

Justification for selection of Effect on fertility via oral route:
The data available do not allow a firm conclusion regarding the NOAEL for reproduction toxicity. Indications are at levels not leading to hypothyroidy, reproduction toxicity is unlikely. Based on the fact that humans are naturally exposed to thiocyanates by food further studies are not considered necessary. For further details see section 13 of the IUCLID5 and section 5.11 of the CSR.

Justification for selection of Effect on fertility via inhalation route:
The likelihood for exposure via inhalation is low. The vapour pressure is extremely low (< 1.33 x 10-8 Pa) and thus does not present any potential for inhalation exposure due to volatilization of the salt. Furthermore thiocyanates are very hygroscopic (see granulometry). Inhalable particles are not available and will also not be formed during handling and use of the substance.

Justification for selection of Effect on fertility via dermal route:
Dermal absorption is lower than absorption via oral route. Testing via dermal route is therefore not preferred.

Effects on developmental toxicity

Description of key information
All studies available for the aspect of reproductive toxicity are articles published in open literature. No GLP studies are available. None of the studies described in the publications is performed according to one of the OECD guidelines on developmental toxicity (OECD 414). Study design sometimes resembles those described the guidelines but none of the studies examined all the parameters requested to evaluate the effects on parents, foetuses and/or pups. Most studies focus only on the effect of thiocyanate on the thyroid function and on the development of the brain of neonates.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
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 above under fertility.

For reproduction toxicity limited data is available. Studies focus on the possible goitrogen effects of thiocyanate. A 2-generation study with fixed dose levels in the food resulting to exposures of 100 -1000 mg/kgbw for the females, resulted to hypothyroidy of the animals, but did not results in overt reproduction toxicity as judged by the normal body weights of the pups. Although data available do not allow a firm conclusion regarding possible NOAEL for reproduction toxicity, based on the fact that humans are naturally exposed to thiocyanates by food, and the additional exposure through use of thiocyanates are limited in comparison, further studies are not considered necessary.


Justification for selection of Effect on developmental toxicity: via oral route:
The data available do not allow a firm conclusion regarding the NOAEL for developmental toxicity. Indications are at levels not leading to hypothyroidy, developmental toxicity is unlikely. Based on the fact that humans are naturally exposed to thiocyanates by food further studies are not considered necessary. For further details see section 13 of the IUCLID5 and section 5.11 of the CSR.

Justification for selection of Effect on developmental toxicity: via inhalation route:
The likelihood for exposure via inhalation is low. The vapour pressure is extremely low (< 1.33 x 10-8 Pa) and thus does not present any potential for inhalation exposure due to volatilization of the salt. Furthermore thiocyanates are very hygroscopic (see granulometry). Inhalable particles are not available and will also not be formed during handling and use of the substance.

Justification for selection of Effect on developmental toxicity: via dermal route:
Dermal absorption is lower than absorption via oral route. Testing via dermal route is therefore not preferred.

Justification for classification or non-classification

The data available do not allow a firm conclusion regarding the NOAEL for reproduction toxicity. Indications are at levels not leading to hypothyroidy, reproduction toxicity is unlikely. Based on the fact that humans are naturally exposed to thiocyanates by food further studies are not considered necessary. For further details see section 13 of the IUCLID5 and section 5.11 of the CSR.

Additional information