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Administrative data

Description of key information

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:
weight of evidence
Justification for type of information:
See read-across justification report, attached to "Toxicological information" section.
Reason / purpose for cross-reference:
read-across source
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
5 000 mg/kg bw
Mortality:
No mortality was observed in rats (set I and II) treated with 2000 mg DPX-C (Di-Cloro-Di-p-Xililene)/kg body weight.
Clinical signs:
No clinical sign was observed in all the rats treated with 2000 mg DPX-C (Di-Cloro-Di-p-Xililene)/kg body weight.
Body weight:
Normal gain in body weight was observed in all the surviving rats.
Gross pathology:
External
External examination of terminally sacrificed rats did not reveal any abnormality.
Internal
Visceral examination of terminally sacrificed rats did not reveal any abnormality.
In absence of any pathological lesion in terminally sacrificed rats, it is concluded that the test item did not produce any treatment related effect at the dose level used in the present study.
Interpretation of results:
other:
Remarks:
Category 5 or Unclassified (GHS 2015)
Conclusions:
LD50 oral for Dibenzetano is estimated to be greater than 2000 mg/L.
Based on the results of this study, an indication of the classification for Dibenzetano is as follows: Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2015): Category 5 or Unclassified.
Executive summary:

LD50 oral for Dibenzetano is estimated to be greater than 2000 mg/L from the result of the source study (see read-across justification report).

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

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
See read-across justification report, attached to "Toxicological information" section.
Reason / purpose for cross-reference:
read-across source
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was observed in rats treated with 2000 mg DPX-C (Di-Cloro-Di-p-Xililene)/kg body weight.
Clinical signs:
No treatment related clinical signs were observed in any of the rats treated with 2000 mg DPX-C (Di-Cloro-Di-p-Xililene)/kg body weight.
Body weight:
All the male rats showed no appreciable change in mean body weight while decrease in the mean body weight was observed in female rats on day 7 which was increased on day 14 when compared to day 0 mean body weight treated with 2000 mg DPX-C (Di-Cloro-Di-p-Xililene)/kg body weight.
Gross pathology:
External
External examination of terminally sacrificed rats did not reveal any abnormality.
Internal
Visceral examination of terminally sacrificed rats did not reveal any lesion.
In the absence of any lesion in terminally sacrificed rats, it is concluded that the test item did not produce any treatment related effect at the dose level used in the present study.
Interpretation of results:
other: Category 5 or Unclassified (GHS 2015)
Conclusions:
The acute dermal LD50 of Dibenzetano in rats is estimated to be greater than 2000 mg/kg body weight.
Executive summary:

The acute dermal LD50 of Dibenzetano in rats is estimated to be greater than 2000 mg/kg body weight, from the result of the source study

(see read-across justification report).

Based on the results of this study, an indication of the classification for Dibenzetano is as follows: Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2015): Category 5 or Unclassified.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification

According to a read-across approach from DPX-C as source substance, the acute LD50cut-off via oral route for Dibenzetano (target substance) is 5000 mg/kg bw and LD50via dermal route is > 2000 mg/ kg bw.

No exposure is expected by inhalation route.

Therefore Dibenzetano is not classified for acute toxicity according to CLP Regulation.

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