Benzenesulfonic acid, 4-dodecyl-, cerium(4+) salt, basic

Endpoint summary

Description of key information

No acute toxicity studies with Benzenesulfonic acid, 4-dodecyl-, cerium(4+) salt, basic are available, thus the acute toxicity will be addressed with existing data on the dissociation products cerium and benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.

 

Signs of acute oral toxicity are not expected for the assessment entity cerium, since the LD50 is greater than 2000 mg/kg bw. The oral LD50 value for the assessment entity benzenesulfonic acid, 4-C10-13-sec-alkyl derivs is 1470 mg/kg bw.

The calculated oral LD50 forBenzenesulfonic acid, 4-dodecyl-, cerium(4+) salt, basicis >2000 mg/kg bw, thus the substance is not classified for acute oral toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Cerium

The acute oral toxicity of cerium chloride was assessed in an OECD 401 study conducted in Sprague Dawley rats. Cerium chloride was solved in water and dose levels of 2500 mg/kg and 3500 mg/kg were administered via gavage to five animals per sex and dose. All animals were observed for 14 days and necropsy was performed as final examination. 3 animals of the 2500 mg/kg dose level died after 2 days and 9 animals of the 3500 mg/kg dose level died after 3 days. The acute oral, single dose LD50 calculated by Probit Analysis was 2800 mg cerium chloride per kilogram body weight with 95% confidence limits of 2360 and 3320 mg/kg. Based on the criteria of the CLP Regulation, the substance should not be classified for acute oral toxicity as the LD50 value is > 2000 mg/kg.

 

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs

Ten rats per dose (five of each sex) were given oral gavage doses of Benzenesulfonic acid, C10-13-alkyl derivs ranging from 1250 to 1990 mg/kg. 9 animals in the 1580 and 1990 mg/kg dose died. In the other doses, the number of animals that died were 0 and 3 of 10 for the 1250 and 1415 mg/kg doses, respectively. The resulting LD50 value was 1470 mg/kg. Benzenesulfonic acid, C10-13-alkyl derivs is slightly toxic to rats following acute oral exposure.

Benzenesulfonic acid, 4-dodecyl-, cerium(4+) salt, basic

Signs of acute oral toxicity are not expected for the assessment entity cerium, since the LD50 is greater than 2000 mg/kg bw. The oral LD50 value for the assessment entity benzenesulfonic acid, 4-C10-13-sec-alkyl derivs is 1470 mg/kg bw.

Under the assumption that the moieties of Benzenesulfonic acid, 4-dodecyl-, cerium(4+) salt, basic show their toxicological profile individually upon dissolution, the acute oral (systemic) toxicity of Benzenesulfonic acid, 4-dodecyl-, cerium(4+) salt, basic can be calculated using the equation given in regulation (EC) 1272/2008, Annex I, Section 3.1.3.6.1.

A study for acute toxicity via inhalation was not conducted with Benzenesulfonic acid, 4-dodecyl-, cerium(4+) salt, basic, since it is produced and placed on the market in a form in which no inhalation hazard is anticipated, thus acute toxic effects are not likely to occur during manufacture and handling of that substance. For further information on the toxicity of the individual moieties, please refer to the relevant section in the IUCLID.

 

The calculated oral LD50 for Benzenesulfonic acid, 4-dodecyl-, cerium(4+) salt, basic is > 2000mg/kg, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity as well as for specific target organ toxicity, single exposure (STOT-SE, oral).

Justification for classification or non-classification

Based on in vivo oral LD50 data on the moieties, acute toxicity estimates for Benzenesulfonic acid, 4-dodecyl-, cerium(4+) salt, basic have been calculated resulting in LD50 values > 2000 mg/kg bw.

According to the criteria of REGULATION (EC) No 1272/2008 and its subsequent adaptions, Benzenesulfonic acid, 4-dodecyl-, cerium(4+) salt, basic does neither have to be classified and has no obligatory labelling requirement for acute oral toxicity nor for specific target organ toxicity after single exposure (STOT SE).