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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:
1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Unnamed
Year:
2001
Report Date:
1980
Reference Type:
review article or handbook
Title:
U.S. HIGH PRODUCTION VOLUME (HPV) CHEMICAL CHALLENGE PROGRAM ROBUST SUMMARY Phosphorous acid, triisodecyl ester (CAS# 25448-25-3)
Author:
General Electric Company on behalf of the Phosphite Producers HPV Consortium and Phosphite Manufacturers Consortium
Year:
2001
Bibliographic source:
US Environmental Protection Agency, HPV Information System

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
use of 3 animals/ sex rather than 5 recommended by the guideline
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Triisodecyl phosphite (CAS# 25448-25-3, Lot #TDPx-003-04070A from
Borg Warner Company, Parkersburg, WV)
Commercial, purity: > 97% (Phosphorus content = 6.17 %)

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
Albino rabbits weighing between 2.0 and 3.0 kg each were used in this study. The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9CFR, Part 3.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
All animals had their backs clipped free of hair 24 hours prior to testing and had their backs abraded prior to dosing. The sample was applied as supplied to the back of each animal at a dose of 5.0 g/kg body weight. These treated areas were covered with large gauze patches and an impervious material was wrapped around the trunk of each animal.
Duration of exposure:
The dressings were removed after 24 hours and any excess material was removed.
Doses:
5.0 g/kg body weight
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
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:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died during the experiment.
Clinical signs:
There were no signs of toxicity, 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:
GHS criteria not met
Conclusions:
The LD50 was determined > 5000 mg/kg bw in the conditions of this limit test.
Executive summary:

The study method was comparable to OECD 402 guideline (except the use of 3 animals/ sex rather than 5 recommended by the guideline).

This study was quoted as reliability 1, reliable without restriction by the Phosphite Producers HPV Consortium and Phosphite Manufacturers Consortium in the US HPV dossier submitted in 2001 and EPA accepted their assessment.

Triisodecyl phosphite at the concentration of 5000 mg/kg bw was applied to the back of Albino rabbits, during 24 hours and observed for a 21- day period for signs of toxicity or mortality.

No death occured during the study and there were no signs of toxicity, except for substantial skin irritation lasting over several days. Gross pathological examination revealed no remarkable findings.

The LD 50 was determined > 5000 mg/kg bw in the conditions of this limit test.