4-hydroxybutyl acrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 Jul 1979 to 03 Oct 1979

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:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

BASF Test: Groups of 10 rats/sex were administered the test substance as an aqueous solution at 4 dose levels by gavage. The animals were observed for clinical signs and lethality several times on the day of administration and then once daily during the 14-day observation period. Body weights were determined after 4, 7, and 13 days. Upon completion of the study all surviving animals were sacrificed and submitted to gross-pathological examination.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-hydroxybutyl acrylate

EC Number:

219-606-3

EC Name:

4-hydroxybutyl acrylate

Cas Number:

2478-10-6

Molecular formula:

C7H12O3

IUPAC Name:

4-hydroxybutyl acrylate

Specific details on test material used for the study:

- Name of test material: Butanediolmonoacrylate
- Substance No.: 78/278

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Spraque-Dawley / Wiga
- Weight at study initiation: 190 - 230 g (males); 160 - 170 g (females)
- Fasting period before study: 15 - 20 h before administration
- Diet (ad libitum): HERILAN MRH-HALTUNG; H. EGGERSMANN KG
- Water: e.g. ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 6.81, 10.00, 14.70, and 20.00 % (w/v)


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

681, 1000, 1470, and 2000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Cageside observations were performed several times on the day of administration and daily on workdays during observation period. Body weights were determined at test start and termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, organ weights, histopathology

Statistics:

LD50 determination by probit analysis; chi square test for homogeneity

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

871 mg/kg bw

Based on:

test mat.

95% CL:

>= 780 - <= 967

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

921 mg/kg bw

Based on:

test mat.

95% CL:

>= 780 - <= 1 083

Effect levels 3

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

823 mg/kg bw

Based on:

test mat.

95% CL:

>= 680 - <= 968

Mortality:

At 2000 and 1470 mg/kg bw, all animals died within 48 hrs and 7 days after administration, respectively. At 1000 and 681 mg/kg bw 14/20 and 3/20 rats died within 48 hrs after dosing, except for one late death at the low dose that occurred in the second week of post-exposure. In general, most of the deaths occurred within 2 days after dosing; however, a few late deaths were also observed.

Clinical signs:

other: Signs of toxicity comprised dyspnoea, apathy, aggression, abnormal position, staggering, atony, paresis of the hind limbs, loss of pain reflex, loss of corneal reflex, narcosis, trembling, twitching, spastic gait, trismus, tonic-clonic convulsions, ruffle

Gross pathology:

In animals that died or were sacrificed, pathological findings included changes of the heart (acute atrial dilatation and acute congestive hyperemia) and of the stomach (mucosal erythema of the glandular stomach; petechial bleeding; superficial ulcers of the epithelium of the glandular stomach and of the forestomach; thickening of the forestomach wall; formation of buttons; and adhesion of the forestomach to the liver, peritoneum and spleen).

Any other information on results incl. tables

Mortality:

 

Dose [mg/kg bw]	Conc. [%]	No. of animals/sex	Dead animals / treated animals after
			1 h	24 h	48 h	7 d	14 d
2000	20.0	10 m	4/10	10/10	10/10	10/10	10/10
		10 f	4/10	9/10	10/10	10/10	10/10
1470	14.7	10 m	0/10	8/10	9/10	10/10	10/10
		10 f	0/10	9/10	10/10	10/10	10/10
1000	10.0	10 m	0/10	7/10	8/10	8/10	8/10
		10 f	0/10	4/10	6/10	6/10	6/10
681	6.81	10 m	0/10	0/10	2/10	2/10	2/10
		10 f	0/10	0/10	0/10	0/10	1/10

m: male

f: female

 

 

Body weights:

 

Dose [mg/kg bw]	No. of animals/sex	Mean body weight [g] after x days
		2-4 d	7 d	13 d
2000	10 m	-	-	-
	10 f	-	-	-
1470	10 m	214	-	-
	10 f	-	-	-
1000	10 m	209	245	272
	10 f	178	189	204
681	10 m	245	267	297
	10 f	179	193	211

m: male

f: female

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria