Diethyl malonate

Endpoint summary

Description of key information

In the in vivo study conducted for skin irritation the test material showed a probability of weak irritation without meeting the criteria for a classification. Thus the test substance is not classified as skin irritating/corrosive.

In the in vivo study conducted for eye irritation the test material showed an irritating potential without causing irreversible damage. Thus the substance is classified as eye irritating category 2 according to GHS.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

other: as described by Smyth et al., Amer. Ind. Hyg. Assoc. J. 23, 95-107

GLP compliance:

not specified

Species:

rabbit

Type of coverage:

open

Preparation of test site:

not specified

Amount / concentration applied:

0.01 ml diethyl malonate

Irritation parameter:

overall irritation score

Basis:

animal:

Score:

2

Max. score:

10

Remarks on result:

probability of weak irritation

Interpretation of results:

GHS criteria not met

Conclusions:

The irritation grade was determined to be 2 of 10. The GHS criteria for a classification are not met.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Reference 2

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:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

at the start of the study the animals weghted 2.54-3.12 Kg and were approximately twelve to sixteen weeks old. After a minimum acclimatisation period of five days each animal was given a number unique within the study which was wrintten with a black indelible marker-pen on the inner surface of the ear and on a cage label.

Vehicle:

not specified

Controls:

other: second eye

Amount / concentration applied:

On the day of the test each animal was held firmly but gently until quiet. Avolum of 0.1 mL of the test materia was instilled into the right eye of each rabbit by gently pulling the lower lid away from the eyeball to form cup into which the test material was dropped.

Duration of treatment / exposure:

Assessment of damage/irritation was made 1, 24, 48 and 72 hours following treatment

Observation period (in vivo):

Adverse ocular effects were noted at the72-hour observation and additioanl readings were made on days seven and fourteen.

Number of animals or in vitro replicates:

6

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1h,24h,48h, 72h, 7d, 14d

Score:

>= 0 - <= 5

Max. score:

5

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 1h,24h,48h,72h,7d,14d,21d

Score:

>= 0 - <= 20

Max. score:

20

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 1h,24h,48h, 72h, 7d, 14d

Score:

>= 0 - <= 15

Max. score:

15

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

other: 1h,24h,48h, 72h, 7d, 14d

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

other: 1h,24h,48h, 72h, 7d, 14d

Score:

>= 0 - <= 30

Max. score:

30

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

other: 1h,24h,48h, 72h, 7d, 14d

Score:

>= 0 - <= 15

Max. score:

15

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1h,24h,48h, 72h, 7d, 14d

Score:

>= 0 - <= 12

Max. score:

12

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 1h,24h,48h, 72h, 7d, 14d

Score:

>= 0 - <= 14

Max. score:

14

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 1h,24h,48h, 72h, 7d, 14d

Score:

>= 0 - <= 12

Max. score:

12

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

other: 1h,24h,48h, 72h, 7d, 14d

Score:

>= 0 - <= 12

Max. score:

12

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

other: 1h,24h,48h, 72h, 7d, 14d

Score:

>= 0 - <= 12

Max. score:

12

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

other: 1h,24h,48h, 72h, 7d, 14d

Score:

>= 0 - <= 16

Max. score:

16

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal:

Time point:

other: 1h,24h,48h, 72h, 7d, 14d

Score:

>= 0 - <= 5

Max. score:

5

Reversibility:

fully reversible

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1h,24h,48h, 72h, 7d, 14d

Score:

>= 4 - <= 25.8

Max. score:

25.8

Reversibility:

fully reversible

Irritant / corrosive response data:

AVERAGE SCORE (24, 48, 72 hours)
- Cornea: 0.6
- Iris: 0.8
- Conjuntivae (Redness): 1.7
- Conjuntivae (Chemosis): 1.3
- Overall irritation score: (Draize score) 25.8 of 110

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The test material diethylmalonate was found to be a moderate irritant to the rabbit eye. The other reactions produced were considered to be reversible.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)