Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., calcium salts

Endpoint summary

Description of key information

The acute toxicity of Branched CaDDBS via oral and dermal exposures was evaluated in rats. The acute oral LD50 was >2000 mg/kg bw.  The acute dermal LD50 was between 1000 and 1600 mg/kg bw (Geometric mean = 1265 mg/kg bw).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 265 mg/kg bw

Additional information

Two acute toxicity studies are available.

In the first, Branched CaDDBS (Phenylsulfonat CA) was given by gavage to male and female Wistar rats at a limit dose of 2000 mg/kg bw. No mortality or other toxic symptoms were observed. No effects on body weight gain were observed. The animals sacrificed at the end of the observation period showed no macroscopically visible changes. The resultant acute oral LD50 is >2000 mg/kg bw.

The acute dermal toxicity of Branched CaDDBS (Phenylsulfonat CA) was tested in male and female Wistar rats at doses of 1000, 1600 and 2000 mg/kg bw. Lethality was observed in the 1600 and 2000 mg/kg bw doses but not in the 1000 mg/kg bw dose. All lethality had occurred by day three of the post application observation period. Other signs of toxicity included impairments of respiration, motility and reflexes, as well as stupor, prone position, trembling, hypothermia, narrowed palpebral fissures, and blood-encrusted snouts, all of which had disappeared by eight days post application. The skin showed erythema, fine and coarse scales, desquamations and scars, as well as discoloration, induration, chapping, scabbing and lumpiness. No effects on body weight gain were observed. The resultant acute dermal LD50 is >1000 and <1600 mg/kg bw. The geometric mean of 1265 mg/kg bw is used as the key value.

Justification for selection of acute toxicity – oral endpoint

No mortality or other toxic symptoms were observed. No effects on body weight gain were observed. The animals sacrificed at the end of the observation period showed no macroscopically visible changes. The resultant acute oral LD50 is >2000 mg/kg bw.

Justification for selection of acute toxicity – inhalation endpoint

In accordance with Column 2 of Annex VIII-IX, in addition to the oral route, for substances other than gases, an acute toxicity study for one other route is required. The choice of the second route will depend on the nature of the substance and the likely route of exposure. As dermal is the most likely route of exposure and acute dermal toxicity data are available, no inhalation study need be conducted.

Justification for selection of acute toxicity – dermal endpoint

Lethality was observed in the 1600 and 2000 mg/kg bw doses but not in the 1000 mg/kg bw dose. All lethality had occurred by day three of the post application observation period. Other signs of toxicity included impairments of respiration, motility and reflexes, as well as stupor, prone position, trembling, hypothermia, narrowed palpebral fissures, and blood-encrusted snouts, all of which had disappeared by eight days post application. The skin showed erythema, fine and coarse scales, desquamations and scars, as well as discoloration, induration, chapping, scabbing and lumpiness. No effects on body weight gain were observed. The resultant acute dermal LD50 is >1000 and <1600 mg/kg bw.

Justification for classification or non-classification

No acute oral toxicity was observed so Branched CaDDBS is not classified under the DSD or CLP. Dermal values would result in classification as R21 under the DSD and Category 4 (H312) under the CLP.