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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes

Test material

1
Chemical structure
Reference substance name:
Dichlorotricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene, mixed isomers
EC Number:
249-236-8
EC Name:
Dichlorotricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene, mixed isomers
Cas Number:
28804-46-8
Molecular formula:
C16H14Cl2
IUPAC Name:
Unknown constituents
Test material form:
solid: granular

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
5 males and 5 females

Administration / exposure

Vehicle:
other: pulverised and moistened with 0.2 mL freshly collected RO water
Details on dermal exposure:
The test item was held in contact with the skin using porous gauze dressing and a non-irritating tape throughout the 24 h exposure period.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females/2000 mg/kg bw

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

Interpretation of results:
other: Category 5 or Unclassified (GHS 2015)
Conclusions:
No mortality was observed following dermal application of 2000 mg DPX-C (Di-Cloro-Di-p-Xililene)/kg body weight. The acute dermal LD50 of DPX-C (Di-Cloro-Di-p-Xililene) in Wistar male and female rats was found to be greater than 2000 mg/kg body weight.
Executive summary:

In an acute dermal toxicity study, a group of 8 to 13 weeks old Wistar rats (5 males and 5 females) was dermally exposed toDPX-C (Di-Cloro-Di-p-Xililene)for 24 h following applicationat a limit dose of 2000 mg/kg body weight. The required amount (506.8 to 598.6 mg) ofDPX-C (Di-Cloro-Di-p-Xililene)(pulverised and moistened with 0.2 mL freshly collected RO water)was applied over the clipped area (approximately7 × 5 cm body surface area) and the rats were observed for a period of 14 days.

There were no treatment-related mortality, clinical signs and necropsy findings recorded.

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.

The acute dermal median lethal dose (LD50) ofDPX-C (Di-Cloro-Di-p-Xililene)in Wistar rats (males and females) was found to be greater than 2000 mg/kg body weight.

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

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