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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:
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

Constituent 1
Chemical structure
Reference substance name:
Phosphorous acid, diphenyl isodecyl ester
Molecular formula:
C22H31O3P
IUPAC Name:
Phosphorous acid, diphenyl isodecyl ester
Constituent 2
Chemical structure
Reference substance name:
Triphenyl phosphite
EC Number:
202-908-4
EC Name:
Triphenyl phosphite
Cas Number:
101-02-0
Molecular formula:
C18H15O3P
IUPAC Name:
triphenyl phosphite
Constituent 3
Chemical structure
Reference substance name:
Diisodecyl phenyl phosphite
EC Number:
247-098-3
EC Name:
Diisodecyl phenyl phosphite
Cas Number:
25550-98-5
Molecular formula:
C26H47O3P
IUPAC Name:
Reaction products of triphenyl phosphite and isodecanol (1:2)
Constituent 4
Reference substance name:
Grouped, low level constituents (1) - see description
Molecular formula:
C21H29O3P and C23H33O3P
IUPAC Name:
Grouped, low level constituents (1) - see description
Constituent 5
Reference substance name:
Grouped, low level constituents (2) - see description
Molecular formula:
N/A
IUPAC Name:
Grouped, low level constituents (2) - see description
Constituent 6
Chemical structure
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 7
Reference substance name:
Grouped, low level constituents (3) - see description
Molecular formula:
N/A
IUPAC Name:
Grouped, low level constituents (3) - see description
Test material form:
liquid

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:
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.

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