Benzenesulfonic acid, 4-C20-24 (even numbered) sec-alkyl derivs.

Endpoint summary

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

Link to relevant study records

Reference

Endpoint:

chronic toxicity: oral

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Justification for type of information:

The justification document on the read across category approach is included in IUCLID section 13.

Dose descriptor:

NOAEL

Effect level:

40 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: increased weight of cecum and slight degeneration of the renal tubes

Dose descriptor:

LOAEL

Effect level:

115 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: increased weight of cecum and slight degeneration of the renal tubes

Critical effects observed:

not specified

Conclusions:

The test substance is considered to have an NOAEL of 40 mg/kg bw and LOAEL 115 mg/kg bw. The substance is not to be classified as STOT RE according to CLP Regulation.

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

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

repeated oral toxicity:

No repeated dose toxicity study via oral administration with either of the target substances HiMo LABS and 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, both target substances HiMo LABS and TSA C20-C24 are 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.