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Endpoint summary

Description of key information

LD50 (oral, rat) > 2000 mg/kg bw (OECD 420, GLP)

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:

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar
toxicological properties because they have common structural features in the same relatives positions. Further information is included in attachment to IUCLID section 13.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source and target chemicals have comparable chemical similarity. Impurities present in the target substance are configurational isomers of the main constituents and are therefore not impacting the chemical similarity between the source and target substances. Further information is included in attachment to IUCLID section 13.

3. ANALOGUE APPROACH JUSTIFICATION
The source and the target have similar physico-chemical, toxicological properties and because of common metabolism they share common or have similar breakdown products and therefore potential mechanisms of action.
The available information on composition, physico-chemistry and toxicity suggests that the substances (source and target) share sufficient common properties, so that read across may be undertaken for the acute oral toxicity endpoint. Further information is included in attachment to IUCLID section 13.

4. DATA MATRIX
Further information is included in attachment to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Conclusions:

As the Rat oral LD50 (females) of the source substance is above 2000 mg/kg bw, by read across approach, the target substance is not classified for acute oral toxicity according to regulation (EC) No. 1272/2008 (CLP) and to GHS.

Executive summary:

The study was performed on a source substance according to OECD 420 and EU Method B1 bis Acute oral Toxicity fixed dose and according to GLP to assess the acute oral toxicity of the test item ST 01 C 11 following a single oral administration.

Groups (5 females/dose) of Wistar (RccHan™:WIST) rats were given a single oral (gavage) dose of test item at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination. Sighting study was conducted at the dose levels of 300 and 2000 mg/kg bw (one female/dose) to determine the dose for main study.

In sighting study, no mortality or clinical signs were observed at 300 and 2000 mg/kg bw. The animal showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy. In the main study, no mortality was observed at 2000 mg/kg bw. No signs of systemic toxicity were noted during the observation period. All animals showed expected gains in bodyweight over the observation period. Dark liver was noted at necropsy of one animal at 2000 mg/kg bw. No abnormalities were noted at necropsy of the remaining animals.

The Rat Oral derived LD50 (females) of the test item is thus above 2000 mg/kg bw.

The target substance is therefore expected to have and acute oral LD50 of > 2000 mg/kg bw. The target substance is not classified for acute oral toxicity according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

> 2 000 mg/kg bw

Quality of whole database:

The available information as a whole meets the tonnage driven information requirements of REACH.

Acute toxicity: via inhalation route

Endpoint conclusion

Quality of whole database:

The available information as a whole meets the tonnage driven information requirements of REACH.

Acute toxicity: via dermal route

Endpoint conclusion

Quality of whole database:

The available information as a whole meets the tonnage driven information requirements of REACH.

Justification for classification or non-classification

The registered substance is not classified for acute oral toxicity according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.