Methacrylic anhydride

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Repeated dose dermal irritation study, histopathology of skin only, study purpose was to investigate skin reactions of dilutions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Materials and methods

Principles of method if other than guideline:

Method: other: application on the shaved backs of mice , male ICR-mice, 8 animals/dose group
100 ul per mouse/day for a total of 9 treatment days

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methacrylic acid

EC Number:

201-204-4

EC Name:

Methacrylic acid

Cas Number:

79-41-4

Molecular formula:

C4H6O2

IUPAC Name:

2-methylprop-2-enoic acid

Details on test material:

purity approx. 100 %

Test animals

Species:

mouse

Strain:

other:

Sex:

male

Administration / exposure

Duration of treatment / exposure:

3 weeks

Frequency of treatment:

3 time/week

Doses / concentrations

Remarks:

Doses / Concentrations:
4 % aq. sol. of MAA and 4.8 - 19.2 % aqueous solution of methacrylic acid in acetone
Basis:

No. of animals per sex per dose:

8 animals/dose group

Control animals:

other: yes (solvent)

Details on study design:

100 ul per mouse/day for a total of 9 treatment days

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Dermal irritation:

effects observed, treatment-related

Description (incidence and severity):

see results

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Details on results:

With MAA as an aqueous solution of 4.8 % (= approx. 150 mg/kg) no skin irritation was observed after single or repeated dermal exposure up to 21 d (treatment interval 2-3 days, 9 exposures). When methacrylic acid was diluted in acetone and applied similarly, concentration-related irritation was observed. At 4.8 % in acetone, there was minimal irritation within the first 72 hours which progressed to slight after 21 d. Moderate to severe irritation was observed with 9.6 % (= approx. 300 mg/kg) and  19.3 % (= approx. 600 mg/kg) solutions with hyperplasia, hyperkeratosis, fibrosis, ulceration and necrosis. No clinical signs indicative of systemic toxicity were observed at any dose in any of the mice.

Effect levels

Dose descriptor:

NOAEL

Effect level:

600 mg/kg bw/day

Sex:

male

Basis for effect level:

other: (= 19.3 % / 2.24 M) Local irritation, but no clinical signs of systemic effects

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Dilutions of MAA in acetone and water show mild irritation at 4.8 % in a study in mice, in which dilutions of MAA were applied for 21 d in succession, while the effects are more pronounced at 9.6 % in acetone and progress to severe irritation at 19.2 % in acetone.

Executive summary:

Dilutions of MAA in acetone and water show mild irritation at 4.8 % in a study in mice, in which dilutions of MAA were applied for 21 d in succession, while the effects are more pronounced at 9.6 % in acetone and progress to severe irritation at 19.2 % in acetone.