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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:
comparable to guideline study with acceptable restrictions
Remarks:
no information on purity of test substance given; 10 animals per group; no males tested

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
24 Feb 1987
Deviations:
yes
Remarks:
10 animals per group; no males tested
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
other: Tyler' s Original Strain
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin and Kingman Ltd., Bull, Yorks, England
- Females nulliparous and non-pregnant: not specified
- Weight at study initiation: 20 ± 4 g
- Fasting period before study: overnight prior to dosing
- Housing: in solid-floor polycarbonate cages
- Diet: Standard Laboratory Diet (41B from E. Dixon and Sons (Ware) Ltd., Berts, England), ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 25 mL/kg bw
Doses:
12.5, 20.0 and 25.0 mL/kg bw (corresponding to 12 326, 19 722 and 24 653 mg/kg bw, respectively, based on a relative density of 0.9861 g/cm³)
No. of animals per sex per dose:
10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed immediately after dosing and thereafter daily for 14 days. Body weight was monitored throughout the period of study.
- Necropsy of survivors performed: no

Results and discussion

Preliminary study:
A preliminary range-finding study was conducted in order to determine the order of acute oral toxicity with respect to lethal effect.
The test substance was administered undiluted by gavage at dose levels of 5, 10, 20 and 25 mL/kg bw to groups of 2 animals each. Animals were observed immediately after dosing and then for a period of 7 days. Any signs of toxicity were recorded. No mortality occured at any dose level, therefore a final maximum dose of 25.0 mL/kg bw and two additional dose levels of 12.5 and 20 mL/kg bw were selected for the main study.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 25 mL/kg bw
Based on:
test mat.
Remarks on result:
other: (corresponding to 24 653 mg/kg bw based on a relative density of 0.9861 g/cm³)
Mortality:
One death was observed within 24 hours of dosing in the 20 mL/kg dose level group. 2 further deaths occurred between Days 3 and 7, both in the 25.0 mL/kg dose level group.
Clinical signs:
Piloerection was observed within 30 min after dosing, and a general loss of activity was apparent for 2 h, persistent for up to 24 h. All survivors appeared asymptomatic after Day 7.
Body weight:
Animals showed a loss in weight prior to death. Other mice also exhibited weight loss particularly at Day 7.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicity study in mice a LD50 value of > 25.0 mL/kg bw (corresponding to 24 653 mg/kg bw based on a relative density of 0.9861 g/cm³) was found.