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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:
From November 07, 1987 to December 03, 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
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)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
other: Acute oral toxicity
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
This is formulation of 49.2% of the test substance in water.
Specific details on test material used for the study:
- ca. 50% Cocobenzyldimethylammonium chloride (CAS no.: 61789-71-7) in water.
- Arquad B-50 is based on full cocoalkylchain: (chain length distribution of
full coco: C8: 5%; C10: 6%; C12: 50%; C14: 19%; C16: 10%; C18:10%.

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
Details on study design:
Dose selection was based upon the results of a range-finding study. Animals, 5 males and 5 females per dose group, were administered the undiluted test substance in a single oral dose by gavage. Animals were observed 1 and 4h after dosing and subsequently once daily for 14 d. 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.

Results and discussion

Effect levels
Key result
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 equivalent to 397.5 mg a.i./kg bw
Body weight:
Surviving animals made expected body weight gains over the study period.
Gross pathology:
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.

Applicant's summary and conclusion

Conclusions:
Under the study conditions, the rat 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 study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 401, in compliance with GLP. Five male and five female rats per dose group were administered the undiluted test substance (50% purity) 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 d. Mortality and evidence of overt toxicity were recorded at each observation. Individual body weights were recorded on the day of treatment (Day 0), Days 7 and 14, and at termination. All animals were subjected to gross necropsy examination for any macroscopic abnormalities. Under the study conditions, the LD50 was determined to be 795 mg/kg bw (equivalent to 397.5 mg a.i./kg bw) for male and females combined (Jones, 1986).