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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No exact guideline or method detailed in report.
GLP compliance:
not specified
Remarks:
pre-GLP report
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
(E)-2-methyl-3-phenylprop-2-enal
Cas Number:
15174-47-7
IUPAC Name:
(E)-2-methyl-3-phenylprop-2-enal
Test material form:
liquid
Specific details on test material used for the study:
Test material was described with the generic name "alpha-methylcinnamaldehyde". As manufactured by Innospec, the product met the criteria of > 80% trans-isomer, supporting that the test material was the isomer better described as CAS 15174-47-7.

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
Compound No. RIFM 72-257

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
1.64, 2.05, 2.56, 3.20, 5.00 g/Kg
No. of animals per sex per dose:
10 animals per dose, no sex details given
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 2 050 mg/kg bw
95% CL:
> 1.83 - < 2.27
Mortality:
On day 1 post oral exposure mortality was observed as follows:
1.64 g/Kg - 2 rats dead
2.05 g/Kg - 4 rats dead
2.56 g/Kg - 8 rats dead
3.20 g/Kg - 10 rats dead
5.00 g/Kg - 10 rats dead
Clinical signs:
other: The animals which died experienced sluggishness prior to death

Any other information on results incl. tables

Table 1. Distribution of Mortality

Dose

(g/Kg)

Observation Day

Mortality

1

2

3

4

5

6

7

8

9

10

11

12

13

14

1.64

2

0

0

0

0

0

0

0

0

0

0

0

0

0

2/10

2.05

4

0

0

0

0

0

0

0

0

0

0

0

0

0

4/10

2.56

8

0

0

0

0

0

0

0

0

0

0

0

0

0

8/10

3.20

10

0

0

0

0

0

0

0

0

0

0

0

0

0

10/10

5.00

10

0

0

0

0

0

0

0

0

0

0

0

0

0

10/10

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures
Conclusions:
Based on observed mortality, the acute oral LD50 of Alpha methyl cinnamic aldehyde was determined to be 2050 mg/Kg (95% confidence interval = 1830 – 2270 mg/Kg).
Executive summary:

In a key fixed dose oral toxicity study, the test material (Alpha methyl cinnamic aldehyde) was orally administered to rats (10/dose) at doses of 1.64, 2.05, 2.56. 3.20, or 5.0 g/Kg.

 

All animals treated at ≥3.20 g/Kg died on day one. At 1.64 g/Kg, 2/10 animals died while 4/10 and 8/10 animals died post exposure to the test material at doses of 2.05 and 2.56 g/Kg, respectively.

 

The acute oral LD50 of Alpha methyl cinnamic aldehyde was therefore determined to be 2050 mg/Kg (95% confidence interval = 1830 – 2270 mg/Kg).