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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
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.