Dichlorotricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene, mixed isomers

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Species:

rat

Strain:

Wistar

Sex:

female

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females/2000 mg/kg bw

Control animals:

no

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:

Based on the results of this study, an indication of the classification for DPX-C (Di-Cloro-Di-p-Xililene) is as follows: Globally Harmonized System of Classification and Labelling og Chemicals (GHS 2015): Category 5 or Unclassified.

Executive summary:

The acute oral toxicity ofDPX-C (Di-Cloro-Di-p-Xililene)was investigated using the acute toxic class method. Female Wistar rats at dosing were given a single oral dose ofDPX-C (Di-Cloro-Di-p-Xililene). The test item was administered in corn oil, following overnight fasting, at dose of 2000 mg/kg body weight andanimalswere observed for 14 days.

There were no treatment-related mortality, clinical sign and changes in body weight or necropsy findings observed.

The acute oral median lethal dose (LD50cut-off value) of DPX-C (Di-Cloro-Di-p-Xililene)in Wistar rats was found to be 5000 mg/kg body weight.

Based on the results of this study, an indication of the classification forDPX-C (Di-Cloro-Di-p-Xililene)isas follows:

Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2015): Category 5 or Unclassified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

Due to the nature of test item, it is not possible to conduct inhalation study.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Justification for classification or non-classification

Due to the nature of test item, it is not possible to conduct inhalation study. Moreover, exposure of humans by inhalation route is estimated as negligible.

The acute LD₅₀cut-off via oral route is 5000 mg/kg bw. The LD₅₀via dermal route is > 2000 mg/kg bw.

Therefore Dichloro-p-cyclophane is not classified according to Regulation (EC) n. 1278/2008 (CLP).