Ethyl formate

Endpoint summary

Description of key information

Skin Irritation

On the skin, the test chemical triggers slight and reversible primary irritation only with prolonged exposure.

Hence, the test chemical was considered to be not irritating to skin.

Eye Irritation:

The test chemical causes marked irritation to the eyes as compared to the eyes treated with  Sodium chloride.

Hence, the test chemical was considered to be irritating to rabbit eyes.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

data is from experimental reports

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the dermal irritation potential of the test chemical in rabbits

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

single

Observation period:

24 hours till 8 days

Number of animals:

no data available

Details on study design:

TEST SITE
- Area of exposure: backs and ears

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 24 hours till 8 days

SCORING SYSTEM:
Sign explanation for skin and mucous membrane irritation:
R - redness; oe= Edema; Sch = Scaling ; N = necrosis; Tr = Cloudiness; Na = scar; (+) = questionable; + = easy; ++ = strong; +++ = very strong; * = unimpressive

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Reversibility:

fully reversible within: 8 days

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

On the skin, ethyl formate triggers slight and reversible primary irritation only with prolonged exposure.

Skin Irritation (Rabbits)

Application Form: undiluted

Exposure time	Findings after 24 hours	Findings after 8 days
Back, 1’	*	*
5’	*	*
15’	*	*
Back, 20’	*	*
Ear, 20’	R+	*

Sign explanation for skin and mucous membrane irritation:

R - redness; oe= Edema; Sch = Scaling ; N = necrosis; Tr = Cloudiness; Na = scar; (+) = questionable; + = easy; ++ = strong; +++ = very strong; * = unimpressive

Interpretation of results:

other: not irritating

Conclusions:

On the skin, the test chemical triggers slight and reversible primary irritation only with prolonged exposure.
Hence, the test chemical was considered to be not irritating to skin.

Executive summary:

The dermal irritation potential of the test chemical was assessed in rabbits. Undiluted ethyl formate was applied to the skin of the ears and back of the rabbits and observed for erythema and edema. The dermal responses were observed and scored from 24 hours after exposure till 8 days.

On the skin, the test chemical triggers slight and reversible primary irritation only with prolonged exposure.

Hence, test chemical was considered to be not irritating to skin.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Data is from Experimental reports

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the extent of ocular damage caused by the test chemical to rabbit eyes

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent negative control

Amount / concentration applied:

undiluted approx 50 mg

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

1, 24 hours till 8 days

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

no data available

Details on study design:

Sign explanation for skin and mucous membrane irritation:
R - redness; oe= Edema; Sch = Scaling ; N = necrosis; Tr = Cloudiness; Na = scar; (+) = questionable; + = easy; ++ = strong; +++ = very strong; * = unimpressive

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 8 days

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Ethyl formate causes marked irritation to the eyes

Eye Irritation (rabbits)

Application form: undiluted (1 * 50 mm3 or 50mg)	Findings after 1 hour	Findings after 24 hours	Findings after 8 days
	R + / * ++ / secretion	R + / o	*
Comparison : NaCl	*	*	*

 

Sign explanation for skin and mucous membrane irritation:

R - redness; oe= Edema; Sch = Scaling ; N = necrosis; Tr = Cloudiness; Na = scar; (+) = questionable; + = easy; ++ = strong; +++ = very strong; * = unimpressive

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The test chemical causes marked irritation to the eyes as compared to the eyes treated with Sodium chloride.
Hence, the test chemical was considered to be irritating to rabbit eyes.

Executive summary:

A study was conducted to determine the extent of ocular damage caused by the test chemical to rabbit eyes.

Undiluted approx 50 mg of the test chemical was instilled into the eyes of rabbits and observed for effects. Sodium chloride was used for comparison of ocular responses. The ocular responses were observed and scored at 1, 24hours till 8 days after application.

The test chemical causes marked irritation to the eyes as compared to the eyes treated with  Sodium chloride.

Hence, the test chemical was considered to be irritating to rabbit eyes.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation:

In various studies, the test chemical has been investigated for potential to cause dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in humans, rabbits for the target chemical. The results are summarized as follows:

The dermal irritation potential of the test chemical was assessed in rabbits. Undiluted test chemical was applied to the skin of the ears and back of the rabbits and observed for erythema and edema. The dermal responses were observed and scored from 24 hours after exposure till 8 days.

On the skin, the test chemical triggers slight and reversible primary irritation only with prolonged exposure.

Hence, the test chemical was considered to be not irritating to skin.

This is supported by results of a closed patch test performed on human volunteers to assess the irritation potential of the test chemical. The test chemical 4% in petrolatum was applied to the skin of human volunteers and exposed for 48 hours.

The test chemical 4% in petrolatum was not irritating to the skin of humans after 48 hours exposure.

In a similar study on humans, 4% test chemical was applied to the skin of human volunteers under occlusive conditions for 48 hours and observed for effects. The test chemical 4% was not irritating to the skin of humans after 48 hours exposure.

The above results are supported by a skin irritation study performed on rabbits to assess the irritation potential of the test chemical. Undiluted the test chemical was applied to the intact and abraded skin of rabbits for 24 hours under occlusion and observed for effects.

Undiluted test chemical was not irritating to the intact and abraded skin of rabbits after 24 hours exposure.

These results are further supported by another study performed on rabbits. The test chemical was applied to the skin of 5 rabbits under occlusive conditions for 24 hours and observed for effects .The dermal reactions were graded on a scale of 1-10, where 1 –being not irritating, 10 – being severely irritating

The test chemical was graded 1 on a scale up to 10, indicating that it doesnot cause any irritation to skin.

Hence the test chemical can be considered to be not irritating to skin.

These results are also supported by one more study performed on rabbits.

460 mg of the test chemical was applied to the skin of rabbits and observed for signs of irritation (duration of exposure, observation period not specified).Mild irritation was observed in rabbits when they were topically exposed to 460 mg of the test chemical. Hence, the test chemical was considered to be mildly irritating to skin.

 

All of the above results are ably supported by a study performed in humans. The test chemical was applied to the skin of human volunteers for 5 hours and observed for effects (dose and other details not specified). The test chemical did not cause irritation in human volunteers for a contact time of 5 hours.

Hence, the test chemical was considered to be not irritating to skin.

Although result of one study in rabbits claims that the test chemical could cause irritation to skin, but results from majority of studies performed on humans, rabbits indicate a very strong possibility of the test chemical being not irritating to skin.

Hence, the test chemical can be considered to be not irritating to skin.Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified under the category “Not Classified”.

Eye Irritation:

In various studies, the test chemical has been investigated for potential to cause ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in humans, rabbits for the target chemical. The results are summarized as follows:

A study was conducted to determine the extent of ocular damage caused by the test chemical to rabbit eyes.

Undiluted approx 50 mg of the test chemical was instilled into the eyes of rabbits and observed for effects. Sodium chloride was used for comparison of ocular responses. The ocular responses were observed and scored at 1, 24hours till 8 days after application.

The test chemical causes marked irritation to the eyes as compared to the eyes treated with  Sodium chloride. Hence, the test chemical was considered to be irritating to rabbit eyes.

This is supported by another study performed in rabbits to assess the ocular irritation potential of the test chemical. 0.5 ml of undiluted test chemical was instilled into the eyes of rabbits and observed for signs of irritation (duration of exposure, observation period not mentioned).Eye injury in rabbits records the degree of corneal necrosis from various volumes and concentrations of chemical. Grade 1 indicates at most a very small area of necrosis resulting from 0.5 ml of undiluted chemical in the eye; grade 5 indicates a so–called severe burn from 0.005 ml, and grade 10 indicates a severe burn from 0.5 ml of a 1% solution in water or propylene glycol.

The test chemical caused moderate reversible injury graded 4 on a scale of 10. Hence, the test chemical was considered to be irritating to rabbit eyes.

The results of both the studies are in mutual agreement with each other indicating a very strong possibility of the test chemical being irritating to eyes. Hence, the test chemical was considered to be irritating to eyes.Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified under the category “Category 2”

Justification for classification or non-classification

Available data forthe test chemical suggests that it is not likely to cause any irritation to skin but causes moderate to severe irritation to eyes.

The test chemical can be classified under the category “Not Classified” for skin irritation and “Category 2” for eye irritation as per CLP regulation.