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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:
15 September 1976 to 06 October 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
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
The study pre-dates the inception of GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl 4-(dimethylamino)benzoate
EC Number:
244-289-3
EC Name:
2-ethylhexyl 4-(dimethylamino)benzoate
Cas Number:
21245-02-3
Molecular formula:
C17H27NO2
IUPAC Name:
2-ethylhexyl 4-(dimethylamino)benzoate

Test animals

Species:
rat
Strain:
other: Albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 200 to 300 grams
- Fasting period before study: Yes, fasted for 24 hours
- Housing: In common cages with other rats on the same dosage level
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50 % w/w in corn oil
Doses:
2.0, 4.0, 8.0, 16.0, 32.0 and 64.0 g/kg
No. of animals per sex per dose:
5 animals per dose. Not specified as to how many males and females per dose level; rats were assigned to various dose levels at random with both sexes being equally distributed.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: No

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
14 900 mg/kg bw
Based on:
test mat.
95% CL:
>= 9 600 - <= 23 000
Mortality:
No deaths were observed at the 2.0 and 4.0 g/kg dose levels. One death was observed at the 8.0 g/kg dose level, 2 deaths were observed at the 16.0 g/kg dose level and 5 deaths were observed at both the 32.0 and 64.0 g/kg dose levels.
Clinical signs:
other: At the 2.0 g/kg dose level, no toxic effects were noted. At the 4.0 g/kg dose level nasal haemorrhage was evident for 24 hours. At the 8.0 and 16.0 g/kg dose levels, nasal haemorrhage was accompanied with wet, oily coats. Slight diarrhoea was noted at the
Other findings:
The test material was equally toxic to males and females.

Any other information on results incl. tables

Table 1: Sumary of Mortality Data

Group No.

No. of animals

Dose level (g/kg)

Number and Day of Deaths

Total

1

2

3

4

5

6

7

8

9

10

11

12

13

14

Survived

Died

I

5

2.0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5

II

5

4.0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5

III

5

8.0

 

 

 

 

 

1

 

 

 

 

 

 

 

 

4

1

IV

5

16.0

 

 

 

 

 

2

 

 

 

 

 

 

 

 

3

2

V

5

32.0

 

 

 

2

2

 

 

1

 

 

 

 

 

 

0

5

VI

5

64.0

 

1

1

3

 

 

 

 

 

 

 

 

 

 

0

5

Applicant's summary and conclusion

Interpretation of results:
other: Not classified in accordance with EU criteria
Conclusions:
Under the conditions of this study, the LD50 was determined to be 14.9 g/kg in the rat.
Executive summary:

The acute oral toxicity of the test material was investigated using methodology similar to the standardised guideline OECD 401.

A group of 30 albino male and female rats were employed to the study to establish an LD50 range for the test material. Fasted animals were dosed by gavage at 2.0, 4.0, 8.0, 16.0, 32.0 and 64 g/kg with the test material at 50 % in corn oil. The test animals were assigned to various dose levels at random; both sexes were distributed equally. After the test material had been administered animals were observed daily for 14 days.

No deaths were observed at the 2.0 and 4.0 g/kg dose levels. One death was observed at the 8.0 g/kg dose level, 2 deaths were observed at the 16.0 g/kg dose level and 5 deaths were observed at both the 32.0 and 64.0 g/kg dose levels.

At the 2.0 g/kg dose level, no toxic effects were noted. At the 4.0 g/kg dose level nasal haemorrhage was evident for 24 hours. At the 8.0 and 16.0 g/kg dose levels, nasal haemorrhage was accompanied with wet, oily coats. Slight diarrhoea was noted at the 16.0 g/kg dose level. The animals dosed at 32.0 g/kg were languid, exhibiting nasal haemorrhage, diarrhoea and wet, oily, unkempt coats.

For the animals dosed at 64.0g/kg, observations included lethargy, nasal and ocular haemorrhage, diarrhoea, wet, oily coats and generally emaciated condition.

Under the conditions of this study, the oral LD50 value for the test material was 14.9 g/kg in both male and female rats.

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