Methyl cinnamate

Endpoint summary

Description of key information

It is concluded that test substance is a non-irritant to the rabbit's eyes and skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

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.

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.

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

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

New Zealand white rabbits of both sexes (weighing 2.3 to 3.4 kg.) were used.

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eyes were used for control

Amount / concentration applied:

3 mg

Duration of treatment / exposure:

N/A

Observation period (in vivo):

at 1, 4, 24, 48, 72 and 96 hours after dosing

Number of animals or in vitro replicates:

6

Details on study design:

Six New Zealand albino rabbits, weighing 2.3 to 3.4 kg., were used to evaluate the irritating properties of each individual test material to the eye. Prior to application, the eyes were examined with the aid of fluorescein ophthalmic solution to confirm the absence of lesions in all eyes. One-tenth of one milliliter of the liquid or 3 mg. of the solid test material was instilled in one eye; the other eye, remaining untreated, served as control.
The ocular reactions to test materials were read post-treatment according to the Draize method at 1, 4, 24, 48, 72, and 96 hours and daily thereafter for a total of seven days (weekends excepted). At seven days, all eyes were reexamined with the aid of fluorescein ophthalmic solution.

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 1 h

Score:

0.17

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 4 h

Score:

0.17

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24 h

Score:

0.17

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

mean

Time point:

other: 4 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 4 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Under the conditons of the study, the test material produced conjunctival redness in 1/6 animals at 1, 4 and 24 hours only. 3 mg eye effects, irritant effects, conjunctival redness was observed in 1/6 animals at 1, 4 and 24 hours only, which cleared by 72 hours. No eye irritation was observed in animals receiving any of the test compounds at two hours.

Other effects:

No systemic toxic effects occurred in rabbits following the instillation of test substance.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results in this study, the test article methyl cinnamate caused no irritation to rabbits' eyes.

Executive summary:

This report was published to evaluate the primary irritation of test substance to rabbits' eyes. One-tenth of one milliliter of the liquid or 3 mg. of the solid test material was instilled in one eye; the other eye, remaining untreated, served as control. The ocular reactions to test materials were read post-treatment according to the Draize method at 1, 4, 24, 48, 72, and 96 hours and daily thereafter for a total of seven days (weekends excepted). At seven days, all eyes were reexamined with the aid of fluorescein ophthalmic solution. No systemic toxic effects occurred in rabbits following the instillation of test substance. Under the condiitons of the study, the test material produced conjunctival redness in 1/6 animals at 1,4 and 24 hours only. 3 mg eye effects, irritant effects, conjunctival redness was observed in 1/6 animals at 1, 4 and 24 hours only, which cleared by 72 hours.

Therefore, it is concluded that test substance caused no irritation to rabbit's eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

One available report (report no. 2110) was published to evaluate the primary irritation of test substance to rabbits' eyes and skin. One-tenth of one milliliter of the liquid or 3 mg. of the solid test material was instilled in one eye; the other eye, remaining untreated, served as control. The ocular reactions to test materials were read post-treatment according to the Draize method at 1, 4, 24, 48, 72, and 96 hours and daily thereafter for a total of seven days (weekends excepted). At seven days, all eyes were re-examined with the aid of fluorescein ophthalmic solution. No systemic toxic effects occurred in rabbits following the instillation of test substance. Under the conditions of the study, the test material produced conjunctival redness in 1/6 animals at 1, 4 and 24 hours only. 3 mg eye effects, irritant effects,conjunctival redness was observed in 1/6 animals at 1, 4 and 24 hours only, which cleared by 72 hours and thus the very slight effects were fully reversible.

In addition, in this report, rabbits were applied dermally 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 rabbit 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 and eye irritation to rabbits during the test period.

Justification for classification or non-classification

Under the experimental conditions applied in a skin and an eye irritation study, methyl cinnamate is not to be classified according to CLP (Regulation EC No.1272/2008) or DSD (Directive 67/548/EEC) respectively. Data on respiratory irritation are not available.