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Toxicological information

Acute Toxicity: oral

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1983
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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
Signs of toxicity, including passiveness, ataxia and salivation, were observed in several animals.
Body weight:
No data
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