Isodecyl acrylate

Endpoint summary

Description of key information

Based on the acute toxicity studies available, isodecyl acrylate shows a low toxicity after a single administration by oral or dermal route, in rats and rabbits respectively. The inhalation of a highly saturated vapour-air-mixture  with isodecyl acrylate represents an unlikely acute hazard.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Animals were treated with a single dose and observed during 14 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mellon Institute
- Age at study initiation: 3 - 4 weeks
- Weight at study initiation: 90 - 120 g
- Diet (e.g. ad libitum): Rockland diets
- Water (e.g. ad libitum): ad libitum

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

undiluted substance

Doses:

20, 10 and 5 ml/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

no

Statistics:

no

Sex:

male

Dose descriptor:

LD50

Effect level:

9 486 mg/kg bw

Remarks on result:

other: original data: 10.7 ml/kg

Remarks:

LD50 (mg/kg) = LD50 (ml/kg) x density x 1000 = 10.7 x 0.8866 x 1000 = 9486 mg/kg

Mortality:

20.0 ml/kg: 5/5 animals died on day 0, 1 ,1 ,3 and 5
10.0 ml/kg: 2/5 animals died on day 2 and 3
5.0 ml/kg: 0/5; all animals survived

Clinical signs:

other: Prostrate and heavy breathing within one hour; sluggish at 24 hours, slightly sluggish 5 min after dose.

Gross pathology:

Congestion throught thee lungs and the abdominal viscera in the victims; livers mottled.

Other findings:

no

Dosage; ml/kg	Dead / Dosed	Days to Death	Weight Change	Signs and/or Sympthoms
20.0	5/5	0,1,1,3,5	-	Prostrate and heavy breathing within one hour; sluggish at 24 hours, slightly sluggish 5 min after dose.
10.0	2/5	2,3	67 to 73
5.0	0/5	-	68 to 91

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results on this acute study, an oral LD50 of 9486 mg/kg was calculated in rats.

Executive summary:

In this study, rats were treated orally with isodecyl acrylate a single dose of 5, 10 or 20 ml/kg.

This study was conducted as a range-finding test according to the method described by Smyth HF Jr. and Carpenter CP (1948).

All animals treated with 20 ml/kg died in the 5 days after administration. Two animals died at the dose of 10 ml/kg on day 2 and 3.

A LD50 value of approx. 9486 mg/kg bw (10,7 ml/kg) was determined.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

9 486 mg/kg bw

Quality of whole database:

It is a reliable study with a klimisch score of 2.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Inhalation Hazard Test was performed.

GLP compliance:

no

Test type:

other: Inhalation Hazard Test

Limit test:

yes

Species:

rat

Strain:

other: Carworth Farms-Elias (Albino)

Sex:

female

Details on test animals or test system and environmental conditions:

no

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

Concentrated vapor, generated at approx. 21 °C by passind dried air at the rate of 2.5 liters/minute through a fritted glass disc immersed to a depth of al least one inch in 50 ml of isodecyl acrylate. The exposure period was eight-hours in a 9-liter chamber.

Duration of exposure:

8 h

Concentrations:

saturated vapour concentration

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

no

Sex:

female

Dose descriptor:

other: Inhalation risk test

Effect level:

ca. 333 mg/m³ air

Exp. duration:

8 h

Remarks on result:

other: No mortality occurred

Mortality:

No animals died.

Clinical signs:

other: All Animals appeared to be normal when removed from the inhalation chamber.

Body weight:

All animals gained weight during the subsequent 14-day observation period.

Gross pathology:

no

Other findings:

no

Single Inhalation by a Group of Female Allbino T´Rats of Concentrated Vapor Generated at approx. 21 °C.

Rat Number	Date and duration of Inhalation	Conc. Mg/L	Initial Weight Grams	Weight Change in 14 Days
54929	5-12-62 8 Hours in 9-Liter Chamber	0.3332	138	+44
54931			128	+10
54932			138	+32
54933			144	+21
54934			142	+40
54945			124	+42

Interpretation of results:

GHS criteria not met

Conclusions:

In an Inhalation Hazard Test, no rats died after an 8 hour-exposure (whole-body) to an atmosphere saturated of isodecyl acrylate (0,3332 mg/L).

Executive summary:

In an Inhalation Hazard Test, no rats died after an 8 hour-exposure (whole-body) to an atmosphere saturated of isodecyl acrylate (0,3332 mg/L). No LC50 was determined.

On the basis of this result, the substance does not warrant classification for an acute inhalation hazard.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

333 mg/m³ air

Quality of whole database:

It is a reliable study with a klimisch score of 2.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Male albino rabbits were immobilized during the 24 -hour contact period with the compound.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.5 kg
- Diet (e.g. ad libitum): Rockland rabbit ration

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Male albino New Zealand strain rabbits, three to five months of age and averaging 2.5 kg. in weight were immobilized during the 24-hour skin contact
period. Thereafter, the polyethylene sheeting used to retain the dose in contact with the clipped skin of the trunk was removed and the animals were
caged for the remainder of the lU-day observation period. The rabbits were procured locally and maintained on Rockland rabbit ration. The moving average method of calculating the LD50 was used.

Duration of exposure:

24 h

Doses:

5, 1.5 and 1.25 ml/kg

No. of animals per sex per dose:

4

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

no

Sex:

male

Dose descriptor:

LD50

Effect level:

3 140 mg/kg bw

Remarks on result:

other: Original data: 3.54 ml/kg

Mortality:

5 ml/kg: 2/4 animals died (on days 2 and 3 after exposure)
2,5 ml/kg: 2/4 animals died (on days 2 and 3 after exposure)
1,25 ml/kg: no animal died

Clinical signs:

other: no details available

Gross pathology:

Gross examination at autopsy revealed congested lungs and brownish, mottled livers and kidneys with surface markings prominent on both organs.

Other findings:

no

Single Doses to Male Albino Rabbits by Skin Penetration Administered Undiluted under Polyethylene Dam for 24 Hrs.

Rat Number	1962 Date Dosed	1962 Date Applied	Grams Weight	Weight Change  in 14 Days	Dosage; ml/kg	Dose in ml	Days to Death
54299	6-4	6-6	2318	-	5.0	11.6	2
54308	6-4	6-6	2300	-	5.0	11.5	3
54311	6-5	6-6	2384	-36	5.0	11.9	-
54313	6-5	6-6	2434	+180	5.0	12.2	-
54260	5-23	5-24	2628	-	2.5	6.6	3
54273	5-28	5-29	2250	-	2.5	5.6	2
54258	5-23	5-24	2472	+584	2.5	6.2	-
54274	5-28	5-29	2335	+279	2.5	5.8	-
52091	5-29	5-31	2314	+346	1.25	2.9	-
54240	5-29	5-31	2540	+350	1.25	3.2	-
54246	5-29	5-31	2134	+286	1.25	2.6	-
54290	5-29	5-31	2244	+251	1.25	2.2	-

LD50: 3.54 (1.17 to 10.7) ml/kg

Interpretation of results:

GHS criteria not met

Conclusions:

According to these experimental conditions, the dermal LD50 is calculated to 3140 mg/kg bw in rabbits.

Executive summary:

In this study, rabbits were treated dermally with isodecyl acrylate a single dose of 1,25 - 2,5 or 5 ml/kg.

Two animals died at the doses of 2,5 and 5 ml/kg on days 2 and 3 after 14 days after administration. No animal died at the dose of 1,25 ml/kg.

A dermal LD50 value of approx. 3150 mg/kg bw was calculated.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 140 mg/kg bw

Quality of whole database:

It is a reliable study with a klimisch score of 2.

Additional information

Oral acute toxicity:

In the key study (Weil 1971), male rats were treated orally with isodecyl acrylate a single dose of 5, 10 or 20 ml/kg and observed during 14 days. This study was conducted as a range-finding test according to the method described by Smyth HF Jr. and Carpenter CP (1948).

All animals treated with 20 ml/kg died in the 5 days after administration. Two animals died at the dose of 10 ml/kg on day 2 and 3. A LD50 value of approx. 9486 mg/kg bw (10,7 ml/kg) was determined.

The same results were observed in the supporting study (Striegel 1962) in which rats were treated orally with isodecyl acrylate a single dose of 8 or 16 ml/kg, and observed during 14 days.

4/5 animals treated with 16 ml/kg died in the 2 days after administration. No mortality was observed in males treated with 8 ml/kg. A LD50 value of approx. 10905 mg/kg bw (12,3 ml/kg) was determined.

Inhalation acute toxicity:

Two Inhalation Hazard Tests are available on isodecyl acrylate. No mortality was observed in this study where rats were treated during 8 hour (whole-body) to an atmosphere saturated of isodecyl acrylate. In the key study, the concentration was 0,3332 mg/L.

Therefore, the LC50 is considered to be higher than 0,3332 mg/L.

On the basis of this result, the substance does not warrant classification for an acute inhalation hazard.

 

Dermal acute toxicity:

In the key study (Striegel 1962), rabbits were treated dermally with isodecyl acrylate a single dose of 1,25 - 2,5 or 5 ml/kg. Two animals died at the doses of 2,5 and 5 ml/kg on days 2 and 3 after 14 days after administration. No animal died at the dose of 1,25 ml/kg. A dermal LD50 value of approx.3150 mg/kg bw was calculated in rabbits.

 

In the supporting study (Weil 1971), rabbits were treated dermally with isodecyl acrylate a single dose of 8 or 16 ml/kg. All four animals treated with 16 ml/kg died in the 7 days after administration. One animal died at the dose of 8 ml/kg on day 3. A dermal LD50 value of approx. 8950 mg/kg bw was determined in rabbits.

Justification for classification or non-classification

Based on the results in all three routes of exposure, no classification for isodecyl acrylate is required for acute toxicity according to the Regulation EC n°1272/2008.