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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:
Oct-Nov 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited information on test material and study conditions, but the study met the general principles of acute toxicity study although prior to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
deviations (lack of reported data, no body weight, no clinical signs or necropsy findings)
GLP compliance:
no
Remarks:
Prior to GLP principles
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
mouse
Strain:
CF-1
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 18-21g
- Fasting period before study: no data
- Housing: wire cages, 5 animals per cage
- Diet (e.g. ad libitum): Lab Blox, ad libitum
- Water (e.g. ad libitum): as libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data (test material received on October 25, 1978).

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE: none used

MAXIMUM DOSE VOLUME APPLIED: 2.5 ml/kg

DOSAGE PREPARATION (if unusual): no data
Doses:
1.25, 1.67 and 2.5 mL/kg bw (corresponding to 1175, 1570 and 2350 mg/kg bw using a specific gravity of ca. 0.94 at 25 °C)
No. of animals per sex per dose:
10 animals per dose (sex unknown)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 5 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data
Statistics:
LD50 calculated using (CHI)2 following the method of Litchfield VT and Wilcoxon F.
J. Pharmacol. Exper. Therapeutics, vol. 96, p.99, 1949.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 513 mg/kg bw
Based on:
test mat.
95% CL:
1 231 - 1 861
Remarks on result:
other: Assuming specific gravity 0.94 at 25 C (company data).
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1.61 mL/kg bw
Based on:
test mat.
95% CL:
1.31 - 1.98
Mortality:
See table under “other information”
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Any other information on results incl. tables

Results

 Group

Dose

(mL/kg bw)
 Mortality

Group mortality

(%) 

 1

1.25 2/10 20
 2  1.67 6/10 60
 3 2.5 8/10 80

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 oral (mice): 1513 mg/kg bw
Executive summary:

The test material was assessed for acute oral toxicity in 10 mice (sex unspecified) weighing 18 to 21 g. The test substance was administered at 1.25, 1.67 and 2.5 ml/kg bw by gavage. The animals were observed for 5 days. Mortality occurred in all dose groups, with two, six and eight animals found dead in the groups administered 1.25, 1.67 and 2.5 ml/kg bw, respectively. The acute oral LD50 of the test material was estimated to be 1.61 ml/kg bw (ca. 1513 mg/kg bw) in mice.

The substance is considered Acute tox. 4, H302 according to EU Regulation 1272/2008 (CLP).