Phenol, dodecyl-, branched

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Limited information is available on materials and methods due to the paper being a summary report, however basic principles look similar to OECD 401, although animals of the same sex should be used per dose and in this study a mix of males and females were used.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Summary Report. Basic principleas as OECD 401 but mix of males & females

Deviations:

yes

Remarks:

See "Principles of method if other than guideline" for details.

Principles of method if other than guideline:

Limited information is available on materials and methods due to the paper being a summary report, however basic principles look similar to OECD 401, although animals of the same sex should be used per dose and in this study a mix of males and females were used.

GLP compliance:

no

Remarks:

Pre-dates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dodecylphenol

EC Number:

248-312-8

EC Name:

Dodecylphenol

Cas Number:

27193-86-8

Molecular formula:

C18H30O

IUPAC Name:

2-dodecylphenol

Details on test material:

Phenol, (tetrapropenyl) derivatives (CAS No. 27193-86-8) ~93% p-dodecylphenol, ~7% o-dodecylphenol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

1260, 1580, 2000, 2510, 3160 and 3980 mg/kg

No. of animals per sex per dose:

5 (mix of males & females)

Control animals:

not specified

Details on study design:

A 14-d observation period followed administration.

Statistics:

Calculation of an LD50 was done according to the method of E.J. de Beer (Journal of Pharmacology and Experimental Therapeutics. 85:1, 1945).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 100 mg/kg bw

Based on:

test mat.

95% CL:

1 620 - 2 730

Mortality:

For the doses of 1260, 1580, 2000, 2510, 3160 and 3980 mg/kg, the number of deaths were 1, 2, 2, 4, 4 and 4, respectively, out of 5 animals per group.

Clinical signs:

other: Clinical signs included weight loss (1 to 6 days in survivors), increasing weakness, diarrhea, collapse and death.

Gross pathology:

Autopsy of decedents showed hemorrhagic lungs, areas of liver discoloration and gastrointestinal inflammation. Viscera of surviving animals appeared normal at sacrifice.

Other findings:

NDA

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material, when administered to 5 rats/dose group, had an acute oral LD50 of 2100 mg/kg.

Executive summary:

The test material was administered by gavage to 6 groups of 5 (mix of M & F) Sprague-Dawley albino rats at doses of 1260, 1580, 2000, 2510, 3160 and 3980 mg/kg. A 14-d observation period followed administration. Calculation of an LD50 was done according to the method of E.J. de Beer.

The calculated oral LD50 for dodecylphenol was 2100 mg/kg (95% confidence limits 1620-2730 mg/kg; slope 3.5). For the doses of 1260, 1580, 2000, 2510, 3160 and 3980 mg/kg, the number of deaths were 1, 2, 2, 4, 4 and 4, respectively, out of 5 animals per group. Clinical signs included weight loss (1 to 6 days in survivors), increasing weakness, diarrhea, collapse and death. Autopsy of decedents showed hemorrhagic lungs, areas of liver discoloration and gastrointestinal inflammation. Viscera of surviving animals appeared normal at sacrifice.