Acrylic acid, monoester with propane-1,2-diol

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:

other: Basic data given (comparable to guidelines/standards). Data were audited by QAU but no reference to GLP standard. Original report not available. Data, reliability and rationale as cited in OECD SIDS (2006).

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1983

Reference 2

Reference Type:

review article or handbook

Title:

OECD SIDS Hydroxypropyl acrylate, CAS No. 25584-83-2.

Author:

OECD SIDS

Year:

2006

Bibliographic source:

OECD SIDS for SIAM 20, UNEP Publications, October 2006.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acrylic acid, monoester with propane-1,2-diol

EC Number:

247-118-0

EC Name:

Acrylic acid, monoester with propane-1,2-diol

Cas Number:

25584-83-2

Molecular formula:

C6H10O3

IUPAC Name:

Reaction mass of 2-hydroxy-1-methylethyl acrylate and 2-hydroxypropyl acrylate

Details on test material:

- Name of test material (as cited in study report): Rocryl 430 (Hydroxypropyl acrylate)
- Analytical purity: 97 %

Test animals

Species:

rat

Strain:

other: CRCD

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 220 - 235 g
- Fasting period before study: yes

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

0, 710, 840, 1000, 1410 and 2000 mg/kg bw

No. of animals per sex per dose:

10 animals/dose (all dose groups except 710 mg/kg bw) and 20 animals/dose (710 mg/kg bw dose group), respectively

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

820 mg/kg bw

95% CL:

760 - 910

Mortality:

For details see Remarks on results including tables and figures.

Clinical signs:

other: Signs of toxicity, including passiveness, ataxia and salivation, were observed in several animals.

Gross pathology:

No gross lesions were observed in any animal that was sacrificed at the end of the 14-day observation period. The following observations were noted in animals that died during the study: stained muzzle, lungs, stomach and intestines red and fluid-filled, and enlarged stomach.

Any other information on results incl. tables

Mortality:

 

Dose group [mg/kg bw]	No. dead / No. dosed
0	0/10
710	4/20
840	5/10
1000	9/10
1410	10/10
2000	10/10

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria