Methyl 3-methoxypropionate

Endpoint summary

Description of key information

A skin irritation study was performed with rabbits. A single semi-occlusive application of methyl-3-methoxy propionate to intact rabbit skin for 4 hrs elicited transient mild dermal irritation. Very slight erythema was observed in 3 animals following the removal of the dressings on day 1 and for the following 2 days. All reactions had resolved by day 4.

No erythema was observed in the remaining 3 animals. No oedema was observed in any of the 6 animals.

Anin vivostudy demonstrated that methyl-3 -methoxy propionate is an eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation / corrosion, other

Remarks:

An in vitro study was not conducted since an in vivo study was already available. The in vivo study was conducted in 1990.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield Farms Ltd., Petersfield, Hampshire, UK
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 2.4-3.0 kg prior to treatment on day 1
- Housing: individually housed
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19
- Humidity (%): 30-70
- Air changes (per hr): approximately 19
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 10 cm2

REMOVAL OF TEST SUBSTANCE
- Washing: with water

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 h

Score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 h

Score:

0

Irritant / corrosive response data:

Very slight erythema only was observed in 3 animals following the removal of the dressings on day 1 and for the following 2 days. All reactions had resolved by day 4. There was no response to treatment in the remaining 3 animals.

Conclusions:

A single semi-occlusive application of methyl-3-methoxy propionate to intact rabbit skin for 4 hours elicited transient mild dermal irritation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation, other

Remarks:

An in vitro study was not conducted since an in vivo study was already available. The in vivo study was conducted in 1990.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Froxfield Farms Ltd., Petersfield, Hampshire, UK
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 2960 g prior to treatment on day 1
- Housing: individually housed
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19
- Humidity (%): 30-70
- Air changes (per hr): approximately 19
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

1

Details on study design:

TOOL USED TO ASSESS SCORE: handheld torch

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Reversibility:

fully reversible within: 14

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 0 - <= 1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 14 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

A corneal opacity had developed the day following instillation but had resolved 14 days following instillation.
Irridial inflammation was only present 3 and 4 days after instillation.
A diffuse crimson-red colouration of the conjunctivae accompanied by obvious swelling with partial eversion of the eyelids was observed.

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Instillation of methyl-3-methoxypropionate into the eye of one rabbit elicited a positive response.

Executive summary:

0.1 mL methyl-3 -methoxypropionate was applied to one eye of a rabbit. A corneal score >1 and a conjuntival redness score of 2 were calculated as the mean scores following grading after 1, 2 and 3 days. The effects were reversible within 14 days. These effects warrant a classification as eye irritant.

Due to the intensity of the response no further animals were exposed to the test substance.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Justification for classification or non-classification

Since only slight (maximum observed score = 1) and transient erythema was observed in an in vivo skin irriation test, methyl-3-methoxy propionate is not classified for skin irritation/corrosion.

Methyl-3 -methoxypropionate was tested for eye irritation/corrosion in an in vivo test. A corneal score >1 and a conjuntival redness score of 2 were calculated as the mean scores following grading after 1, 2 and 3 days. The effects were reversible within 14 days. These effects warrant a classification as eye irritant.