Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
additional toxicological information
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: data taken from existing studies on similar product
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
other: position paper
Title:
Unnamed
Year:
2006

Materials and methods

Type of study / information:
Position paper
Principles of method if other than guideline:
n/a

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-220-8
EC Name:
-
Cas Number:
5945-33-5
Molecular formula:
C39H34O8P2
IUPAC Name:
4-(2-{4-[(diphenoxyphosphoryl)oxy]phenyl}propan-2-yl)phenyl diphenyl phosphate; 4-{2-[4-({[4-(2-{4-[(diphenoxyphosphoryl)oxy]phenyl}propan-2-yl)phenoxy](phenoxy)phosphoryl}oxy)phenyl]propan-2-yl}phenyl diphenyl phosphate
Constituent 2
Reference substance name:
(1-methylethylidene)di-4,1-phenylene tetraphenyl diphosphate
IUPAC Name:
(1-methylethylidene)di-4,1-phenylene tetraphenyl diphosphate
Details on test material:
n/a

Results and discussion

Any other information on results incl. tables

See enclosed position paper on Neurotoxicty related to questions from CA RIVM, The Netherlands

Applicant's summary and conclusion

Conclusions:
Since the structure of BDP is very similar to that of RDP, one can “read across” with confi-dence that BDP does not have neurotoxic activity. Clearly, the chemical structure of BDP does not have the structural elements required to induce OPIDN via a neurotoxic metabolite. It therefore seems improper to conduct an animal study, just to confirm the lack of neurotoxic activity in a molecule that, because of its chemical structure, is obviously unable to inhibit NTE by 70% and cause OPIDN.
Executive summary:

Since the structure of BDP is very similar to that of RDP, one can “read across” with confi-dence that BDP does not have neurotoxic activity. Clearly, the chemical structure of BDP does not have the structural elements required to induce OPIDN via a neurotoxic metabolite. It therefore seems improper to conduct an animal study, just to confirm the lack of neurotoxic activity in a molecule that, because of its chemical structure, is obviously unable to inhibit NTE by 70% and cause OPIDN. If considered necessary, the above can be further clarified in a meeting.