Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14.05. - 23.08.1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics" (Food and Drug Administration)
Principles of method if other than guideline:
"Appraisal of the safety of chemicals in foods, drugs and cosmetics" (Food and Drug Administration)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Analogous test substance

Test animals

Species:
other: rat/mouse
Details on test animals and environmental conditions:
rat: male/female
mouse: female

Conditions:
Air-conditioned with approx. 15 air changes per hour, temperature 20 ± 2°C and relative humidity 50% ± 5%, 12 hours artificial light /12 hours dark.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
food deprivation priot testing: 16 h
diet/water: ad libitum
Doses:
rat:
10% aqueous solution: 600, 800, 900 mg/kg bw
20% aqueous solution: 700 mg/kg bw

mouse:
5% aqueous solution: 625, 700, 775, 850, 925 mg/kg bw
No. of animals per sex per dose:
mouse (female): 10
rat (male/female): 6
Control animals:
yes
Details on study design:
Observation period: 14 days

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
650 mg/kg bw
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
700 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
813 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The test substance has to be classified as slightly toxic according to Hodge and Sterner.
Executive summary:

The following results were found under the described test conditions:

1. In the examined dosages the test substance leads to the following toxic symptoms:

loss of activity, piloerection, diarrhea and exitus.

2. The LD50 was found to be:

650 mg/kg bw in female Wistar rats

700 mg/kg bw in male Wistar rats

3. The test substance has to be classified as slightly toxic according to Hodge and Sterner.