Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1959-03-16 - 1959-09-07
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study conducted prior to GLP, no guideline available, deficiencies in documentation, route of application not relevant for humans or to assess systemic toxicity as possible first pass metabolism is neglected.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1959
Report Date:
1959

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The test item was applied via intraperitoneal injection at doses of 1 resp. 2.5 g/kg bw to each 3 male rats.
GLP compliance:
no
Remarks:
test conducted prior to GLP implementation
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): 2,2'-Dioxy-3,3'-dicyclohexyl- 5-5'-dimethyl-diphenylmethan
- Substance type: pure substance

Test animals

Species:
rat
Strain:
other: white
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: tragacanth
Details on exposure:
Test item was applied as aqueous tragacanth suspension.
Doses:
1 and 2.5 g/kg bw
No. of animals per sex per dose:
3 males per dose
Control animals:
no
Details on study design:
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: highest dose tested, no symptoms of poisoning or deaths observed
Sex:
male
Dose descriptor:
LD0
Effect level:
>= 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: highest dose tested, no symptoms of poisoning or deaths observed
Mortality:
no deaths noted
Clinical signs:
no symptoms of poisoning observed

Applicant's summary and conclusion

Conclusions:
The study conducted prior to GLP, there is no guideline available and deficiencies in documentation were noted. The route of application is not relevant for humans or to assess systemic toxicity as possible first pass metabolism is neglected. In consequence, the study alone may not serve to justify classification, but it is not contradicting to the results obtained in the other available studies on acute toxicity, on the contrary, the results are consistent. Hence, it supports the conclusion not to classify 2,2'-Dioxy-3,3'-dicyclohexyl- 5-5'-dimethyl-diphenylmethan as acutely toxic.
Executive summary:

In an acute toxicity study, groups of 3 white male rats were given a single intraperitoneal injection of 2,2'-Dioxy-3,3'-dicyclohexyl- 5-5'-dimethyl-diphenylmethan in tragacanth at doses of 1000 and 2500 mg/kg bw.

 

LD50(ip) > 2500 mg/kg bw

LD0(ip) ≥ 2500 mg/kg bw

None of the animals died during the test or showed any signs of toxicity.

 

2,2'-Dioxy-3,3'-dicyclohexyl- 5-5'-dimethyl-diphenylmethan is classified as being of low toxicity.