Triisotridecyl phosphite

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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

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.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triisodecyl phosphite

EC Number:

246-998-3

EC Name:

Triisodecyl phosphite

Cas Number:

25448-25-3

Molecular formula:

C30H63O3P

IUPAC Name:

Phosphorus acid, triisodecyl ester

Constituent 2

Reference substance name:

246-998-3.

IUPAC Name:

246-998-3.

Details on test material:

- Name of test material (as cited in study report): Triisodecyl phosphite - Commercial, purity: > 97% (Phosphorus content = 6.17 %)- Lot/batch No.: TDPx-003-04070A- Supplier: Borg Warner Company, Parkersburg, WV

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

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE- Area of exposure: dorsal- Type of wrap if used: These treated areas were covered with large gauze patches and an impervious material was wrapped around the trunk of each animal. REMOVAL OF TEST SUBSTANCE- Washing (if done): excess material was removed. - Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

5.0 g/kg body weight

No. of animals per sex per dose:

3

Control animals:

no

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:

> 5 000 mg/kg bw

Mortality:

No animals died during the experiment.

Clinical signs:

other: 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:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

No signs of dermal toxicity at the limit dose of 5 g/kg.

Executive summary:

No acutely toxic via the dermal route at limit dose of 5 g/kg. Not classified as acutely toxic.