1,4-butanediyl diacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,4-butanediyl diacrylate

EC Number:

213-979-6

EC Name:

1,4-butanediyl diacrylate

Cas Number:

1070-70-8

Molecular formula:

C10H14O4

IUPAC Name:

4-(prop-2-enoyloxy)butyl prop-2-enoate

Details on test material:

- Name of test material (as cited in study report): Butandioldiacrylat
- Analytical purity: > 90 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WIGA
- Weight at study initiation: male: 190-220g; female: 160-190g
- Fasting period before study: 15-20 hours
- Diet: Herlian MRH-Haltung; H. Eggersmann KG

ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
0.5 % aqueous carboxymethylcellulose formulation

DOSE (mg/kg) | 2150 | 1470 | 1000| 681 |
conentration % (w/v) | 21.5 | 14.7 | 10.0 | 6.81 |

MAXIMUM DOSE VOLUME APPLIED:
Dose volume: 10 ml/kg

Doses:

681, 1000, 1470, 2150 mg/kg bw

No. of animals per sex per dose:

10 (one exception: only 9 female animals for dose 1470 mg/kg bw)

Control animals:

no

Details on study design:

- Duration of observation period following administration: at least 14 days
- Frequency of observations: multiple observations after administration up to 5 hours afterwards; then daily (but not on weekends)
- Frequency of weighing: day 2-5, and also on day 7, 13 and 21
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsies were performed on all animes that died or were sacrificed.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 544 mg/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 195 mg/kg bw

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 336 mg/kg bw

Mortality:

male: female: male/female
Dose: 681 (mg/kg bw) 1/10 (10%) 0/10 (0%) 1/20 (5%)
Dose: 1000 (mg/kg bw) 2/10 (20%) 3/10 (30%) 5/20 (25%)
Dose: 1470 (mg/kg bw) 5/10 (50%) 8/9 (88.9%) 13/19 (68.4%)
Dose: 2150 (mg/kg bw) 7/10 (70%) 9/10 (90%) 16/20 (80%)

Clinical signs:

other: Clinical signs (day 0 is day of application; no time specification in brackets: true for whole observation period) 2150 mg/kg bw: irregular breathing, apathy, gasping (day 0-3), tremor, spastic movement, ruffled fur, aggressiveness (day 15-20), diarrhea (

Gross pathology:

animals that died:
Heart: acute dilatation of the vestiubules; acute congestive hyperanemia; Liver: peripheral lobus pattern; Stomach: severe vascular injection; partly reddened with extensive bleeding; intestine: vascular injection, atonic, hematinized and diarrheic content; in some cases substance-related malacia of the mucosa; in some cases prominent bleeding of areas of the mucosa; hydrothorax
sacrificed animals:
stomach: forestomach wall thickened, forestomach agglutination; in some cases so-called "button"-formation; in some cases diverticulum formation

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 in rats for butandioldiacrylate was 1336 mg/kg bw.