2,3-epoxypropyl methacrylate

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

sub-chronic toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Unspecified test guideline and unpublished

Data source

Reference

Reference 1

Title:

No information

Author:

Landry

Year:

1996

Bibliographic source:

Landry, T. et al., Unpublished report of The Dow Chemical Company (13-wk inhalation in rats) (1996)

Reference 2

Title:

No information

Author:

OECD

Year:

1999

Bibliographic source:

OECD SIDS for glycidyl methacrylate, December 1999

Materials and methods

Test guideline

Guideline:

other: no data

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2,3-epoxypropyl methacrylate

EC Number:

203-441-9

EC Name:

2,3-epoxypropyl methacrylate

Cas Number:

106-91-2

Molecular formula:

C7H10O3

IUPAC Name:

oxiran-2-ylmethyl methacrylate

Details on test material:

Supplied by the Dow Chemical Company, Identification # IL13016601, Purity: 99.5 %

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

Age at study initiation was 8 weeks old.

Administration / exposure

Route of administration:

inhalation: vapour

Duration of treatment / exposure:

13 weeks

Frequency of treatment:

6 hours per day, 5 days per week

Doses / concentrations

Remarks:

Doses / Concentrations:
0.5, 2 and 15 ppm (2.9, 12 and 87 mg/m3, calculated daily dose 0.35, 1.46 and 10.59 mg/kg/day)
Basis:
nominal conc.

No. of animals per sex per dose:

10

Control animals:

yes, concurrent vehicle

Details on study design:

Post exposure observation period: 1 day.
Statistical analysis: Statistical significance by Dunnett’s test or Wilcoxon Rank-Sum test with a Bonferroni correction for multiple comparisons.
Age at study initiation was 8 weeks old.

Examinations

Statistics:

Statistical analysis: Statistical significance by Dunnett’s test or Wilcoxon Rank-Sum test with a Bonferroni correction for multiple comparisons.

Results and discussion

Results of examinations

Details on results:

MALE:
At 87 mg/m3 Hyperplasia of respiratory epithelium of the nasal tissues, graded as very slight, in all animals. The hyperplastic respiratory epithelium was approximately two to three times as thick as that of control animals, and was located in the anterior portions of the nasal passages, involving the tips of the turbinates and the lateral walls of the nasal passages.

FEMALE:
At 87 mg/m3 Hyperplasia of respiratory epithelium of the nasal tissues, graded as very slight, in all animals. The hyperplastic respiratory epithelium was approximately two to three times as thick as that of control animals, and was located in the anterior portions of the

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

12 mg/m³ air (nominal)

Sex:

male/female

Basis for effect level:

other: Hyperplasia of respiratory epithelium of the nasal tissues, graded as very slight, in all animals.

2

Dose descriptor:

LOAEL

Effect level:

87 mg/m³ air (nominal)

Sex:

male/female

Basis for effect level:

other: Hyperplasia of respiratory epithelium of the nasal tissues, graded as very slight, in all animals.

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Remarks:

There were no treatment related in-life observations, and no significant treatment-related effects on body weight, urinalysis, clinical chemistry or hematology parameters, as well as gross pathologic changes or organ weights at any exposure levels.

The changes observed in respiratory tract were likely resulted from the irritation of glycidyl methacrylate.

Conclusion:

Repeated dose toxicity in rats by inhalation is hyperplasia in nasal tissues and NOAEL is 2 ppm (equivalent to 12 mg/m3 or 1.46 mg/kg/day).