2-ethylhexyl 4-(dimethylamino)benzoate

Endpoint summary

Description of key information

Based on the available data, the oral LD50 value for the test material (50 % in corn oil) was 14900 mg/kg in both male and female rats.

No acute toxicity study is available by dermal route or by inhalation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

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.

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	0
II	5	4.0															5	0
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

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the LD50 was determined to be 14.9 g/kg in the rat (50% in corn oil).

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 (50% in corn oil) was 14.9 g/kg in both male and female rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

14 900 mg/kg bw

Quality of whole database:

Two studies are available to address this endpoint, one key and one supporting. The studies were conducted prior to the inception of GLP though are considered to be adequate for risk assessment purposes. The key information is included in the reports. The quality of the database is therefore considered to be good.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute Oral Toxicity

In the key study, 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 (50% in corn oil) was 14.9 g/kg in both male and female rats.

 

In the supporting study, 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 cm3/kg with the test material at 5 % 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.

At the 2.0, 4.0, 8.0, 16.0 and 32.0 cm3/kg concentrations there were no deaths; at 64.0 cm3/kg, there were two deaths. At 16 .0 cm3/kg and below, animals did not exhibit any toxic effects. At 32.0 cm3/kg animals exhibited mild diarrhoea and ruffled and wet coats. Normalcy prevailed within 72 hours. At the 64.0 cm3/kg dose level, slight ocular haemorrhage and moderate diarrhoea for 48-72 hours following forced feeding and excessive lacrimation were noted. Coats were wet and unkempt for 72-96 hours post dosing; survivors returned to normal within 96 hours.

Under the conditions of this study, the LD50 of the test material (5% in corn oil) was determined to be in excess of 64.0 cm3/kg.

 

 

 

Justification for classification or non-classification

Based on the available data, no classification for acute toxicity is required for 2-ethylhexyl 4-(dimethylamino)benzoate according to the Regulation (EC) No 1272/2008.