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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:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Charles River Albino (COBS)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
ranging from 0.6 to 2.0 g/kg bw
No. of animals per sex per dose:
2 males and 2 females per dose
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 000 mg/kg bw
Mortality:
see "Other results incl Tables"

Any other information on results incl. tables

The acute oral median lethal dose (LD50) was calculated using the techniques of Weil (1952), Thompson (1947), and Thompson and Weil (1952).

 

Acute Oral Toxicity Study with Albino Rates – Mortality and Body Weight Data

 

Dose*
(g/kg)

Animal Number and Sex

Individual Body Weights (grams) Test Day Number

Number Dead / Number Tested

Percent Dead

0

14

0.6

1-M

252

342

0/4

0

2-M

242

326

3-F

183

234

4-F

180

230

0.9

5-M

233

346

2/4

50

6-M

220

(2 days)

7-F

196

(3 days)

8-F

178

243

1.4

9-M

176

283

3/4

75

10-M

249

(6 days)

11-F

194

(2 days)

12-F

197

(2 days)

2.0

13-M

214

(3 days)

4/4

100

14-M

221

(3 days)

15-F

220

(3 days)

16-F

184

(6-22 hours)

Note: Figures in parentheses indicate time of death

* Benzonitrile ws administered undiluted.

Acute Oral LD50 = 1.0 g/kg

Standard Deviation of LD50 =±.2 g/kg

Summary of Reactions to the Acute Oral Toxicity Study of Albino Rats

Dose
(g/kg)

Reaction

Time of Onset following Dose Administration (hours)

Duration of Reaction (days)

Time of Death Following Dose Administration (days)

0.6

Hyperactivity

6-22

2

-

Muscular weakness

6-22

2

Ruffed fur

6-22

2

0.9

Hyperactivity

1

3

2-3

Muscular weakness

1

3

Ruffed fur

6-22

2

Prostration

6-22

2

1.4

Hyperactivity

1

4

2-6

Muscular weakness

1

4

Ruffed fur

6-22

4

Prostration

6-22

2

2.0

Hyperactivity

1

Until death

6 hours3 days

Muscular weakness

1

 

Ruffed fur

6-22

 

Prostration

6-22

 

Dyspnea

6-22

 

Lacrimation

1 day

 

 

 

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Conclusions:
The acute oral median lethal dose (LD50) for oral application of benzonitrile on rats was determined at: LD50= 1.0 g/kg.

Executive summary:

In an acute oral toxicity study 4 groups (2 male + 2 female each) of young Albino rats (body weight ranged from 176 to 252 grams) were given a single oral dose of undiluted benzonitrile at doses of 0.6, 0.9, 1.4 and 2.0 g/kg bw.  Animals were then observed for 14 days.

Oral LD50 Combined = 1.0 g/kg  bw (Standard Deviation of LD50 =±0.2 g/kg)

Benzonitrile is of slight toxicity based on the combined LD50. According (EC) 1272/2008 benzonitrile is classified as acute toxic Category 4.