Methyl cinnamate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

N/A

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well documented, available information is sufficient for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methyl cinnamate

EC Number:

203-093-8

EC Name:

Methyl cinnamate

Cas Number:

103-26-4

Molecular formula:

C10H10O2

IUPAC Name:

methyl 3-phenylacrylate

Test material form:

solid: crystalline

Details on test material:

Chemical name: Methyl cinnamate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

New Zealand white rabbits of both sexes (weighing 2.5 to 3.0 kg.) were used.

Test system

Type of coverage:

open

Preparation of test site:

other: abraded and intact

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

5 g/kg bw

Duration of treatment / exposure:

24hr

Observation period:

daily for 14 days

Number of animals:

2

Details on study design:

The data obtained from acute oral LD50 studies in rats indicated relatively low toxicity of all test materials. Higher dosages were not used since LD50 values would have little meaning. Therefore, only one selected dose level of each compound was applied to a group of four rabbits of both sexes (weighing 2.5 to 3.0 kg). The dose site, approximately 240- cm2 (about 10% of body surface) was closely clipped. The skin of two of the animals was abraded and the skin of the two remaining animals was left intact. The skin was slightly moistened with physiological saline prior to application. Solid test materials were first ground to fine powders and then applied to the rabbit skin and covered with a nonabsorbent binder.
Animals were immobilized for 24 hours in stocks. Immediately following the removal of the binders, the local effects of the test compounds were scored according to the method of Draize. Toxic effects, dermal irritation, and mortality were recorded daily for 14 days. A necropsy was performed on each animal that died during the experiment and on those killed (by air embolism) at termination. Abnormal tissues and samples of adrenal, kidney, liver, lung, spleen, gonads, urinary bladder, bone, and skin were preserved in 10% formalin for possible histologic examination.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Remarks:

intact and abraded skin

Basis:

mean

Time point:

other: 14day

Score:

0

Max. score:

8

Reversibility:

other: not relevant

Remarks on result:

other: scores were recorded gradually as none, very slight, well defined, moderate to severe and severe

Results 2

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

mean

Time point:

other: at all times

Score:

0

Max. score:

4

Reversibility:

other: not relevant

Remarks on result:

other: scores were recorded gradually as none, very slight, well defined, moderate to severe and severe

Results 3

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

other: at all times

Score:

0

Max. score:

4

Reversibility:

other: not relevant

Remarks on result:

other: scores were recorded gradually as none, very slight, well defined, moderate to severe and severe

Results 4

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

mean

Time point:

other: at all times

Score:

0

Max. score:

4

Reversibility:

other: not relevant

Remarks on result:

other: scores were recorded gradually as none, very slight, well defined, moderate to severe and severe

Results 5

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

other: at all times

Score:

0

Max. score:

4

Reversibility:

other: not relevant

Remarks on result:

other: scores were recorded gradually as none, very slight, well defined, moderate to severe and severe

Irritant / corrosive response data:

There was no skin irritation to either intact or abraded skin following treatment with test substance.

Other effects:

There was no mortality observed during the test with methyl cinnamate. All animals appeared to be normal throughout the entire 14-day observation period. No gross pathologic findings occurred in the rabbit that were killed at termination.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, no dermal irritant effects were produced after administration of the undiluted test material to the intact or abraded skin of rabbits.

Executive summary:

This study was conducted to investigate the acute dermal toxicity of test substance. Rabbits were applied at dosage level of 5 g/kg body weight. There was no mortality during the test. All animals appeared to be normal throughout the entire 14-day observation period. No gross pathologic findings occurred in the rabbits that were killed at termination. There was no skin irritation to either intact or abraded skin following treatment with test substance.

Therefore, undiluted test substance failed to cause skin irritation to rabbits during the test period.