Registration Dossier
Registration Dossier
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EC number: 701-374-4 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to OECD 402, except this limit test used 3 animals/sex rather than 5/sex as recommended by the guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Other (1980). The method employed in the testing, evaluation, and the scoring of the results was similar to the methods described in Section 1500.40 of the U.S. Federal Hazardous Substances Act Regulations, 16 CFF, pg. 123. [Comparable to OECD Test Guideline 402]
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of triphenyl phosphite and isodecanol (1:2)
- EC Number:
- 701-374-4
- Cas Number:
- 25550-98-5
- Molecular formula:
- C26H47O3P
- IUPAC Name:
- Reaction products of triphenyl phosphite and isodecanol (1:2)
- Details on test material:
- - Name of test material (as cited in study report): Diisodecyl phenyl phosphite
- Commercial, purity: Not stated (Phosphorus content = 7.09%)
- Lot/batch No.: PDDP-002-03240A
- Supplier: Borg Warner Company, Parkersburg, WV)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.0 and 3.0 kg
- Housing: The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR, Part 3.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area
- Type of wrap if used: large gauze patches and an impervious material was wrapped around the trunk of each animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, excess material was removed - Duration of exposure:
- 24 hours
- Doses:
- 5.0 g/kg body weight
- No. of animals per sex per dose:
- 3
- Control animals:
- other: Used for data submission
- Details on study design:
- - Duration of observation period following administration: 21 days
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 other: g/kg
- Mortality:
- No animals died during the experiment
- Clinical signs:
- other: No remarkable findings were observed, with the exception of significant skin irritation lasting over several days.
- Gross pathology:
- Gross pathological examination revealed no remarkable findings.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- No acute effects were observed from dermal exposure of 2 g/kg.
- Executive summary:
Test substance was not acutely toxic via the dermal route.
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