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Description of key information

Repeated dose toxicity oral: No repeated dose oral toxicity study with the target substance is available. A chronic study with the category substance LABS Na is considered the pivotal dataset to cover this endpoint. The NOAEL is considered to be 40 mg/kg bw/day, the LOAEL 115 mg/kg bw/day.

Repeated dose toxicity dermal: No repeated dose toxicity via dermal route of administration is not available. As exposure of humans via dermal route in production or use is not likely, this is considered not required.

Repeated dose toxicity inhalation: No repeated dose toxicity via inhalation is not available. As exposure of humans via inhalation in production or use is not likely, this is considered not required.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
40 mg/kg bw/day
Study duration:
chronic
Species:
rat
System:
gastrointestinal tract
Organ:
other: cecum

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

repeated oral toxicity:

No repeated dose toxicity study via oral administration with the target substances TSA C20-C24 is available. Data generated with the category substance LABS Na was considered pivotal to cover this endpoint.

short-term toxicity: Male and female rats were exposed to LABS Na via gavage daily for 28 days. Body weight gain was suppressed, some serum biochemical measures were different from the controls, and some organ weights were either decreased (spleen, heart, thymus) or increased (liver) in either the male or female high dose groups. No mortalities or histopathological abnormalities were observed. The resultant LOAEL and NOAEL values were 250 and 125 mg/kg bw/day, respectively.

chronic study: Male and female rats were exposed to LABS Na in the diet daily for 6 months. Diarrhea, suppressed growth, increased cecal weight and degeneration of renal tubes characterized the highest dose group. Similar but less severe signs were seen in other doses with the exception of the lowest dose of 0.07%, which showed no adverse effects related to exposure to LABS Na. The resultant NOAEL and LOAEL values were 40 and 115 mg/kg bw/day, respectively. This represents the lowest LOAEL of any study. The substance is therefore considered not to be classified as STOT RE.

Based on the data described above, target substance TSA C20-C24 is considered to have a NOAEL of 40 mg/kg/day and LOAEL of 115 mg/kg bw/day, established in a chronic toxicity study with dietary administration. This implies that the substances are considered not to be classified as STOT RE. 

repeated toxicity via inhalation:

No repeated dose toxicity via inhalation administration with the target substance is available.

A repeated toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely.

According to the REACH Regulation, only most appropriate route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). A key repeated dose toxicity study via the oral route of exposure is considered.

Therefore, there is no need to perform a repeated dose toxicity study via the inhalation route of exposure with the target substance.

repeated dermal toxicity:

No repeated dose toxicity via dermal administration with the target substance is available.

A repeated toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely.

According to the REACH Regulation, only most appropriate route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). A key repeated dose toxicity study via the oral route of exposure is considered.

Therefore, there is no need to perform a repeated dose toxicity study via the dermal route of exposure with the target substance.

Justification for classification or non-classification

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