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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From 07 November, 1987 to 03 December, 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
ca. 50% Cocobenzyldimethylammonium
chloride (CAS no.: 61789-71-7) in water.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: undiluted test substance
Doses:
500, 794, 1,260 and 2,000 mg/kg bw
No. of animals per sex per dose:
10

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
795 mg/kg bw
Based on:
test mat.
95% CL:
585 - 1 081
Remarks on result:
other: (795 mg/kg bw of test substance is equivalent to 397.5 mg a.i./kg bw)

Any other information on results incl. tables

Surviving animals made expected body weight gains over the study period.

Necropsy of decedents revealed abnormally red lungs, dark livers, haemorrhage and ulceration of the gastric mucosa and
congestion of the small intestines. Major abnormalities seen at necropsy of animals killed at termination were white
thickened areas of the non-glandular region of the stomach. Scattered white raised areas were also noted.

LD50 = 795 mg/kg bw for male and females combined. (95% confidence levels 585 - 1081)

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the study conditions, the LD50 of the test substance was determined to be 795 mg/kg bw (i.e., equivalent to 397.5 mg a.i./kg bw) for male and females combined, with 95% confidence levels of 585 - 1081.
Executive summary:

A guideline study was conducted in rats to determine the acute oral toxicity of C12-16 ADBAC. Five males and five females per dose group were administered undiluted test substance (50% pure) in a single oral dose by gavage at the dose levels of 500, 794, 1260 and 2000 mg/kg bw. Animals were observed 1 and 4 h after dosing and subsequently once daily for 14 days. Deaths and evidence of overt toxicity were recorded at each observation. Individual body weights were recorded on the d of treatment (Day 0), Days 7 and 14, and at death. All animals were subjected to gross necropsy examination for any macroscopic abnormalities. Under the study conditions, the LD50 was determined to be 795 (i.e., equivalent to 397.5 mg a.i./kg bw) for male and females combined with 95% confidence levels of 585 - 1081 (Jones JR and Collier TA, 1986).