Sodium anisate

Endpoint summary

Description of key information

Oral (equivalent or similar to OECD 401), rat: LD50 > 5000 mg/kg bw

Read-across from p-anisic acid (CAS 100-09-4)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Refer to analogue justification provided in IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other:

Remarks:

source: CAS 100-09-4, Bayer, 1979, rat

Mortality:

At 5000 mg/kg bw two animals died on day 4. No mortalities occurred at 3100 mg/kg bw.

Clinical signs:

At 5000 mg/kg all animals showed clinical signs (diarhoea and increased diuresis). No clinical signs were noted at 3100 mg/kg bw.

Interpretation of results:

GHS criteria not met

Conclusions:

The read across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their acute toxicity potential. The acute oral LD50 in rats was found to be > 5000 mg/kg bw for the source substance p-anisic acid (CAS 100-09-4). Therefore, an acute oral LD50 value of > 5000 mg/kg bw is considered for the hazard assessment and C&L purposes for the target substance sodium anisate.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 2) from a surrogate substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s) (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

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

Justification for read-across

There are no experimental data available regarding the acute toxicity of sodium anisate (CAS 536-45-8). Thus, read-across from an appropriate surrogate substance (p-anisic acid, CAS 100-09-4) is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5 in order to fulfil the standard information requirements defined in Regulation (EC) No 1907/2006, Annex VII and VIII, 8.1. Common functional groups and structural similarities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

The acute oral toxicity of p-anisic acid (CAS 100-09-4) was assessed in a study performed equivalent or similar to OECD Guideline 401 (Bayer, 1979). Two groups of 10 male Wistar rats were treated with the test material at dose levels of 3100 and 5000 mg/kg bw. The test material was administered by gavage using peanut oil as vehicle. The animals were observed for 14 days. At the high dose two animals died on day 4 and all animals showed clinical signs of toxicity (diarhoea and increased diuresis). Neither mortalities nor clinical signs were noted at 3100 mg/kg bw. The acute oral LD50 value of the test material was therefore > 5000 mg/kg bw.

The target and source substances are considered unlikely to differ in their acute toxicity potential. Therefore, an acute oral LD50 value of > 5000 mg/kg bw was considered for the hazard assessment and C&L purposes for the target substance sodium anisate (CAS 536-45-8).

Justification for classification or non-classification

Based on read-across, the available data on acute oral toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.