Distillate of tobacco leaf, Nicotiana tabacum, solanaceae

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, non-guideline, animal experimental study, restrictions in design and or reporting but otherwise adequate for assessment

Justification for type of information:

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Acetic acid is one of the main components of the target substance (1.9-9.9%). The majority of the target substance consists of water, which is non-toxic and thus would not contribute to the oral toxicity of the target substance.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source substance is pure acetic acid. The target substance is a UVCB which consists mostly of water (66.7-95.3%), and contains 1.9-9.9% acetic acid.

3. ANALOGUE APPROACH JUSTIFICATION
Use of data on acetic acid is justified for determining the toxic properties of the target substance due to it being one of the main components of the target substance (1.9-9.9%). As the majority of the target substance is water, which is non-toxic, any potential toxic properties would be due to the organic components of the substance.

Data source

Reference

Reference Type:

publication

Title:

The acute oral toxicity of acetic, chloroacetic, dichloroacetic and trichloroacetic acids

Author:

Woodard G, Lange SW, Nelson KW and Calvery HO

Year:

1941

Bibliographic source:

J Ind Hyg Toxicol, Vol 23, PP 78-82

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The sodium salt of acetic acid was administered by oral gavage to groups of rats (at a dose rate of approx. 0.1 mL/g bodyweight). The rats were fasted for 18 hours prior to dosing. The animals were observed for 6 days following dosing.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium acetate

EC Number:

204-823-8

EC Name:

Sodium acetate

Cas Number:

127-09-3

Molecular formula:

C2H4O2.Na

IUPAC Name:

sodium acetate

Details on test material:

- Name of test material (as cited in study report): acetic acid
- Ionisation constant: 1.86 x 10 E-5
- Acetic acid was adjusted with sodium hydroxide, before dosing, to pH between 6 and 7

Specific details on test material used for the study:

- Name of test material (as cited in study report): acetic acid
- Ionisation constant: 1.86 x 10 E-5
- Acetic acid was adjusted with sodium hydroxide, before dosing, to pH between 6 and 7

Test animals

Species:

rat

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: predominantly males
- Age: 70-100 days
- Weight: 150-250 g
- No further details

IN-LIFE DATES: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

Dose concentration: 0.01 cc/g bw

Doses:

2239, 2512, 2859, 3100, 3500, 4000, 4467 mg/kg

No. of animals per sex per dose:

10, except for 2859 mg/kg group when only 5 were dosed

Control animals:

no

Details on study design:

- Duration of observation period following administration: 6 days

Statistics:

Dose-mortality curves prepared according to the methods of Bliss (Bliss CI. An. Appl. Biol. 22, 134 (1935)) and according to the example described by Laug et al (Laug EP, Calvery HO, Morris HJ and Woodard G, J. Ind. Hyg. Toxicol. 21, 173 (1939)).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 310 mg/kg bw

Remarks on result:

other: sodium salt of acetic acid

Mortality:

1/10, 0/10, 3/5, 5/10, 6/10, 7/10, 8/10 for 2239, 2512, 2859, 3100, 3500, 4000, 4467 mg/kg respectively.

Clinical signs:

other: No data

Gross pathology:

No data

Any other information on results incl. tables

Dose Level (mg/kg bw)	Mortality (number)	Number in Group
2.239	1	10
2.512	0	10
2.859	3	5
3.1	5	10
3.5	6	10
4.0	7	10
4.467	8	10

 

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The acute oral LD50 of the sodium salt of acetic acid was 3310 mg/kg bw for rats.

Executive summary:

The acute oral toxicity of acetic acid was determined in by exposing rats by oral gavage to sodium acetate.  The dosage levels tested were 2239, 2512, 2859, 3100, 3500, 4000, 4467 and mg/kg.  10 rats per group were exposed, except for the 2859 dose level where only 5 rats were exposed.  The acute oral LD50 of the sodium salt of acetic acid was 3310 mg/kg bw for rats.