Reaction mass of 2-ethylhexyl diphenyl phosphite and bis(2-ethylhexyl) phenyl phosphite and triphenyl phosphite

Acute Toxicity: dermal

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:

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)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

diphenyl isodecyl phosphite

IUPAC Name:

diphenyl isodecyl phosphite

Test material form:

other: liquid

Details on test material:

Diphenylisodecyl phosphite (CAS# 26544-23-0, Lot #DPDP-001-03240A from 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
- 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: 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:

> 5 000 mg/kg bw

Clinical signs:

other: No remarkable findings were observed, with the exception of significant skin irritation lasting over several days. No animals died during the experiment and gross pathological examination revealed no remarkable findings.

Gross pathology:

Gross pathological examination revealed no remarkable findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 (rabbit) > 5 g/kg bw. DPDP is not classifiably as to acute dermal toxicity.

Executive summary:

In a limit dose dermal acute study of DPDP in rabbits at 5000 mg/kg no mortality was observed. LD50 (rabbit) > 5000 mg/kg bw. DPDP is not classifiably as to acute dermal toxicity.