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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
This endpoint study record is the experimental source record for the registered target substance.

Data source

Reference
Reference Type:
publication
Title:
RANGE-FINDING TOXICITY DATA: LIST IV
Author:
Smyth HF, Carpenter CP & Weil CS
Year:
1951
Bibliographic source:
AMA Arch Ind Hyg Occup Med (1951) 4:199-122

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Lacking details in methodology and results
GLP compliance:
no
Remarks:
Study pre-dates GLP requirements
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
no impurities described

Test animals

Species:
rat
Strain:
other: Wistar or Sherman
Sex:
male
Details on test animals and environmental conditions:
weighing 90 to 120 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
Not reported. The authors state rats are given dosages differing in a ratio of 10.
No. of animals per sex per dose:
6 rats/dose group
Control animals:
not specified
Details on study design:
Single oral administration was performed in non-fasted animals with an initial start dose, derived from "experience with other substances". One week later other doses were tested with new groups of animals until two doses (differing by a factor of 10) were determined which kill some or all animals and some or no animal, respectively. The duration of observation period following administration was 14 days.
Statistics:
LD50 values (designated as "range finding LD50") were calculated by a method to Thompson (Bact. Reviews, 11: 115, 1947) and reported ± 1.96 standard devistions (SD).

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
22 800 mg/kg bw
Based on:
test mat.
Mortality:
Not reported
Clinical signs:
Not reported
Body weight:
Not reported
Gross pathology:
Not reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral toxicity was low (LD50: 22800 mg/kg bw).
Executive summary:

The work of this group pre-dates range finding toxicity guidelines and provided much of the basis for their development. Their results are cited by many subsequent authoritative review bodies and are often found in SIDS and SIAR documents via secondary references. Therefore, these results are deemed reliable.

Non-fasted rats were given single oral doses. The LD50 (observation period: 14 days) was 22800 mg/kg bw.