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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:
November 9, 1976 - December 21, 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
lack of study design details in the report, observation period of only 7 days, no body weight measurements, no data about the clinical examinations and necropsy
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
- Physical state: Aqueous solution
- Appearance: No data
- Composition of test material, percentage of components: see section confidential details on test material

Test animals

Species:
rat
Strain:
other: Charles River
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River
- Age at study initiation: no data
- Weight at study initiation: 200-300 g
- Fasting period before study: 18 hours
- Housing: Raised wire mesh cages
- Diet (e.g. ad libitum): Lab Blox ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
The test material was diluted 1+1 (w/w) with water just prior to dosing.
Doses:
5.0, 5.5, 6.25 and 6.5 mL/kg bw (aqueous solution)
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: daily observations (no weighing)
- Necropsy of survivors performed: yes
Statistics:
The method of Litchfield & Wilcoxon (1949) was used for calculating the oral LD50.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5.85 mL/kg bw
Based on:
test mat.
Remarks:
(aqueous solution)
95% CL:
5.4 - 6.3
Remarks on result:
other: Aqueous solution with a solid content of approximately 50%
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
6 844.5 mg/kg bw
Based on:
test mat.
Remarks:
(aqueous solution)
Remarks on result:
other: Aqueous solution with a solid content of approximately 50%
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 422 mg/kg bw
Based on:
other: expressed as solid content
Remarks on result:
other: Results expressed for the substance
Mortality:
One, three, seven and seven animals died in the group of rats receiving 5.0, 5.5, 6.25 and 6.5 mL/kg bw (aqueous solution), respectively
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

Any other information on results incl. tables

RESULTS: 

Group

Dose

(mL/kg b.w.)

(aqueous solution)

Mortality

Group mortality

(%)

1

5.0

1/10

10

2

5.5

3/10

30

3

6.25

7/10

70

4

6.5

7/10

70

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study conducted equivalent to OECD 401, the LD50 was determined to be 5.85 mL/kg (aqueous solution), converted to be 6844 mg/kg (as the density is 1.17 g/mL). This would correspond to a LD50 of 3422 mg/kg for the substance.
Executive summary:

The test material was tested as an aqueous solution (ca. 50% solids) for acute oral toxicity in the rat. The test article was administered as a 1:1 dilution in water in a single oral dose at 5.0, 5.5, 6.25, and 6.5 mL/kg dose volumes to groups of 10 fasted rats. Examinations for mortality and clinical signs were performed daily for 7 days. One and 3 animals died in the groups administered 5.0 and 5.5 mL/kg, respectively. Seven animals died in the groups receiving 6.25 and 6.5 mL/kg of the test substance. Based on these results, the acute oral LD50 was calculated to be 5.85 mL/kg (aqueous solution), with 95% confidence limits of 5.4 - 6.3 mL/kg.

With a density documented to be approximately 1.17, the LD50 is estimated to be 6844 mg/kg for the aqueous solution. This corresponds to a LD50 of 3422 mg/kg for the substance.