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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

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
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1.61 mL/kg bw
Based on:
test mat.
95% CL:
1.31 - 1.98
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).
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 harmful by ingestion, Xn, R22, according to the criteria of Annex VI to Directive 67/548/EEC, or Acute tox. 4, H302 according to EU Regulation 1272/2008 (CLP).