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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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:
Clinical signs included weight loss (1 to 6 days in survivors), increasing weakness, diarrhea, collapse and death.
Body weight:
Weight loss occured.
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.

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