Registration Dossier
Registration Dossier
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EC number: 413-110-2 | CAS number: 135861-56-2
Endpoint summary
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
- 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.
Reference
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
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.
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