Registration Dossier

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 OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
other: Data needed for CSR report
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triphenyl phosphite
- Commercial purity: > 97% (Phosphorus content = 10.0 %)
- Lot/batch No.: TPPx-Z18-04080A
- Supplier: Borg Warner Company, Parkersburg, WV

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals 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:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: All animals had their backs clipped free of hair 24 hours prior to testing and had their backs abraded prior to dosing.
- Type of wrap if used: large gauze patches and an impervious material was wrapped around the trunk of each animal.

REMOVAL OF TEST SUBSTANCE
- The dressings were removed after 24 hours and any excess material was removed.
Duration of exposure:
24 hours
Doses:
5.0 g/kg body weight. The sample was dosed as supplied (described as a colorless to straw-colored liquid).
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 21 days
- Frequency of observations and weighing: The animals were observed for a 21-day period for signs of toxicity and mortality.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 - < 5 other: g/kg
Mortality:
At 2 g/kg, no animals died. At a dose of 5 g/kg, all three males and females died. Deaths occurred over approximately 2-3 days after dosing.
Clinical signs:
After 5-6 hours, the animals appeared cold, and lethargic. They became semi-comatose after 18 hours. At 2 g/kg, there were no remarkable findings, except for substantial skin irritation lasting over several days.
Gross pathology:
Gross pathological examination revealed no remarkable findings.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
LD50 (rabbit) > 2 g/kg bw. TPP is not classifiably as to acute dermal toxicity.
Executive summary:

LD50 (rabbit) > 2 g/kg bw. TPP is not classifiably as to acute dermal toxicity.