Reaction product of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. and Benzenesulfonic acid, 4-methyl- and sodium hydroxide

Endpoint summary

Description of key information

There are GLP guideline oral acute toxicity studies for the reaction product and the two substances that comprise it CAS No. 68411-30-3 sodium 4-undecylbenzenesulfonate and CAS No. 12068-03-0 sodium toluenesulfonate.   The LD50 values are 2240, 1080 and >3000 mg/kg bw, respectively in guideline studies.  Per EU criteria all three test substances are deemed "practically non-toxic".  There is a single dermal study for CAS No. 68411-30-3 sodium 4-undecylbenzenesulfonate. The LD50 value is >2000 mg/kg bw.
In accordance with column 2 of REACH Annex VIII-X, in addition to the oral route, for substances other than gases, an acute toxicity study for at least one other route is required.  The choice of the second route depends on the nature of the substance and the likely route of human exposure.  As dermal is the most likely route of exposure and acute dermal toxicity data is available, no data gap exists.   There is however an inhalation study for a related substance, a hydrotrope similar to one of the read across substances; there was no toxicity observed at the 6.41 mg/L dose over the 231 minute exposure.   

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 240 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Value:

mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

There are additional acute oral and dermal toxicity studies for related, read across substances. The results of these supporting studies are consistent with the three key studies. The conclusions from all the studies is that these substances are practically non-toxic.

One inhalation study is a 1980 (non-GLP) acute inhalation study with ammonium xylene sulphonate (CAS No. 26447-10-9) that is a 232-minute, limit test, exposure of male and female rats with no vehicle and a 14-day post exposure observation period. There were no deaths at the 6.41 mg/L dose. Aerosolization was done by a DeVilbiss Nebulizer and exposures were in glass chambers. One of the 10 animals demonstrated clinical signs (soft stool), 2 of the 10 had slight weight gains at days 7 and 14, and 5 of the 10 showed slight mottling or a moderate congestion of lungs at necropsy. The conclusion was reported as "practically nontoxic".

Another inhalation study is conducted with the constituent Benzenesulfonic acid, dodecyl, sodium salt. However, this study is regarded as Klimisch 3. Test substance identity is uncertain and even not representative of LAS; study lacks proper analytical information. No mortality occurred at concentrations up to 260 mg/m3. At 310 mg/m3, one rat died during exposure and 2 rats died one day post exposure. The test material is considered moderately toxic by inhalation. However, it is important to note that this laboratory exposure is not representative of the possible LAS exposure during actual use. Given this lack of relevance to real-world exposure potential, the use of this study for risk assessment purposes is limited.

Justification for classification or non-classification

The available studies with oral, dermal and inhalation exposure demonstrate that the reaction product is of low acute toxicity. No classification is warranted according to EU CLP regulation.