Registration Dossier

Administrative data

Description of key information

no toxic effects observed

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Conclusions:
To assess the acute inhalational toxicity of 1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol, a kinetic based calculation was done based on acute oral and dermal toxicity studies.

In conclusion, the extrapolated acute inhalation toxicity (4 h, LC50) of 1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol was 11.15 mg/L for female and 12.2 mg/L for male.
Executive summary:

The extrapolation route to route could be performed to evaluate the inhalation toxicity of the test susbtance. The two oral and dermal acute toxicity studies available were limit tests performed at the highest possible test concentration. the results indicated no effects and no mortality. The inhalation route could be a possible route of exposure and the LC50 could be estimate based on dermal and oral toxicity studies. the LC50 values are 11.15 mg/L for female and 12.2 mg/L for male.

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
report on test substance provided by ECHA using 12 year rule

Justification for selection of acute toxicity – inhalation endpoint
An extrapolation from oral and dermal route could be done to evaluate the inhalation toxicity study which is a potential way of exposure. applying WoE complies with the REACH regulation to avoid animal testing, the extrapolated acute inhalation toxicity (4 h, LC50) of 1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol was 11.15 mg/L for female and 12.2 mg/L for male.

Justification for selection of acute toxicity – dermal endpoint
report on test substance provided by ECHA using 12 year rule

Justification for classification or non-classification

In the limit test at 5000 mg/kg bw on rat by oral route (according to OECD 401), no moratlity were observed and no important toxic effect. In the dermal toxicity limit test at 2000 mg/kg, no motality or toxicity were observed.

An extrapolation route could be done for the inhalation exposure.

The substanec is not classified for acute toxicity by the 3 routes of exposure (oral, dermal and, inhalation) according to the citeria of DSD and CLP.