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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

skin irritation/corrosion, rabbit: not irritating

Read across from structural analogue source substance propane-1,2-diyl diacetate (CAS 623-84-7).

 

eye irritation, rabbit: not irritating

Data obtained with the registered substance and read-across from structural analogue source substance propane-1,2-diyl diacetate (CAS 623-84-7).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
refer to analogue justification provided in IUCLID section 13
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all 5 animals
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: skin injury, no effect observed at 0.01 mL, Source CAS 623-84-7
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all 5 animals
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: skin injury, no effect observed at 0.01 mL, Source CAS 623-84-7
Interpretation of results:
other: inconclusive
Executive summary:

The skin irritation / corrosion potential of the target substance is estimated based on an in vivo study of structural analogue source substances propane-1,2 -diyl diacetate (CAS 623-84-7). 0.01 mL of the undiluted test substance was applied to the shaved bellies of 5 rabbits for a period of 24 h under open conditions. No skin irritation was observed up to 24 h after exposure. As only a tenth of the dose used according to OECD guideline 404 was applied and no scoring was performed, the study does not fulfill standard requirements which are sufficient for hazard assessment. However, the available study on acute dermal toxicity from the read-across source substance propane-1,2 -diyl diacetate (CAS 623-84-7) does not indicate skin irritation or corrosion up to the limit dose level (see Acute toxicity). As explained in the analogue justification, the differences in molecular structure between the target and the source substance are unlikely to lead to differences in the skin irritation / corrosion potential. Therefore, the target substance is also considered to exhibit no significant skin irritating properties.

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
refer to analogue justification provided in IUCLID section 13
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: Source: CAS 623-84-7
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: Source: CAS 623-84-7
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: Source: CAS 623-84-7
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: Source: CAS 623-84-7
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Executive summary:

The eye irritation potential of the target substance is estimated based on adequate and reliable in vivo studies of structural analogue source substances propane-1,2 -diyle diacetate (CAS 623-84-7). The undiluted test item was applied to the eyes of three female rabbits. The eyes were observed and reactions were evaluated 1, 24, 48 and 72 h after application. No effects on cornea, iris and no conjunctival redness were observed in any animal during the study period. No further local or systemic effects were reported. As explained in the analogue justification, the differences in molecular structure between the target and the source substance are unlikely to lead to differences in the eye irritation potential. Therefore, the target substance is also considered to exhibit no significant eye irritating properties.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

There are no data on skin irritation available for ethylene diacetate. Thus, a read across was performed from the structurally related substance propane-1,2-diyl diacetate (CAS 623-814-7). In a non-GLP study 0.01 mL of the undiluted test substance was applied to the shaved bellies of 5 rabbits for a period of 24 h under open conditions (Union Carbide Corporation, 1965). No skin irritation was observed up to 24 h after exposure. However, only a tenth of the dose used according to OECD guideline 404 was applied and no scoring of skin reaction was performed. Therefore, the study did not meet important criteria of today's standard methods and was thus not taken into account for hazard assessment.

However, the available study on acute dermal toxicity from the read-across source substance propane-1,2-diyl diacetate (CAS 623-84-7) does not indicate skin irritation or corrosion up to the limit dose level (refer to IUCLID section 7.2, acute toxicity). Therefore, the substance is considered to be not irritating to skin.

 

Eye irritation

A publication with limited data investigating the eye irritation properties of ethylene diacetate (CAS 111-55-7) is available. The eye irritation properties of ethylene diacetate were tested in a non-guideline in vivo study (Carpenter, 1946). In groups of 5 albino rabbits (no further information given), 0.5 mL the undiluted test substance were applied in a single application without washing. The eyes were observed and reactions were evaluated 18-24 h after application. The individual numerical scores of each eye treated with a given volume or concentration of the test substance were added together and then divided by the number of eyes to obtain a score of the injury caused by the treatment. The level of 5 was selected as representative of severe injury. This figure corresponded to necrosis, visible after staining and covering about 3/4 of the surface of the cornea; or a more severe necrosis covering a smaller area. The injury grade, after application of 0.5 mL of undiluted ethylene diacetate resulted in a calculated score of ≥ 0 to ≤ 1 out of five eyes after 18-24 h corresponding to the lowest injury grade of the test.

In order to fulfil the standard information requirement, read-across from the structurally related analogue substance propane-1,2-diyl diacetate (CAS 623-84-7) is conducted. The eye irritation properties of propane-1,2-diyl diacetate were tested in a study according to OECD guideline 405 under GLP conditions (Hazleton, 1984). In a group of 3 female rabbits (New Zealand White), 0.1 mL of the undiluted test substance was applied into one eye. The eyes were observed and reactions were evaluated 1, 24, 48 and 72 h after application. No effects on cornea, iris and no conjunctival redness were observed in any animal during the study period. No further local or systemic effects were reported.

Under the experimental conditions described, it was concluded, that no evidence of eye irritation properties were seen after treatment with propane-1,2-diyl diacetate.

 

Conclusion

In conclusion, ethylene diacetate (CAS 111-55-7) is considered to be not irritating to the skin based on read-across data for acute dermal toxicity (refer to IUCLID section 7.2, acute toxicity). One study from ethylene diacetate and one study from the structurally related source substance propane-1,2-diyl diacetate (CAS 623-84-7) did not show eye irritation properties.

Based on this result, no skin or eye irritation potential for ethylene diacetate (CAS 111-55-7) was identified.

Justification for classification or non-classification

Based on read-across from the source substance propane-1,2-diyl diacetate (CAS 623-84-7) and substance specific data on ethylene diacetate (CAS 111-55-7), the available data on skin and eye irritation properties do not meet the criteria for classification according to Regulation (EC) No. 1272/2008. The data are therefore conclusive but not sufficient for classification.