Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 sensitisation, rabbit (OECD 406, Buehler): not sensitising

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

 

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction: 0% Challenge: 0, 1, 5 and 25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Source: CAS 623-84-7
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Induction: 25% Challenge: 0, 1, 5 and 25%
No. with + reactions:
2
Total no. in group:
19
Clinical observations:
Diffuse skin reddening at the skin site exposed to 25% (v/v)
Remarks on result:
other: Source: CAS 623-84-7
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction: 0% Challenge: 0, 1, 5 and 25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Source: CAS 623-84-7
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Induction: 25% Challenge: 0, 1, 5 and 25%
No. with + reactions:
0
Total no. in group:
19
Remarks on result:
other: Source: CAS 623-84-7
Group:
positive control
Remarks on result:
other: Source: CAS 623-84-7
Remarks:
data lacking
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Executive summary:

The skin sensitisation potential of the target substance is estimated based on an adequate and reliable in vivo study of the structural analogue source substance propane-1,2 -diyl diacetate (CAS 623-84-7). In a Buehler test, guinea pigs were first epicutaneously induced and afterwards epicutaneously challenged with the source substance with an occlusive dressing at concentrations of 25, 5, 1 and 0% (v/v). 

Two animals exposed to 25% (v/v) of the source substance propane-1,2 -diyl diacetate (CAS 623-84-7) showed a diffuse skin reddening at the treatment site on Day 29. The effect was fully reversible within 24 h, indicating that the effect may be not due to sensitisation. No further skin reactions were observed, therefore the source item was considered not sensitising. As explained in the analogue justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the skin sensitisation potential. Thus, the target substance is also considered to exhibit no skin sensitising properties.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation

No studies are available investigating the skin sensitisation properties of ethylene diacetate (CAS 111-55-7). 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 study was conducted according to OECD guideline 406 in compliance with GLP (NOTOX, 1986). Female guinea pigs (20 in test group, 10 in control group) were induced with nine occlusive epicutaneous exposures at 25% of the test substance in propylene glycol. The epicutaneous challenge was conducted ten days after the last induction using 0.05 mL of a series of test substance concentrations (25, 5, 1 and 0% (v/v)) in propylene glycol. The negative control group was treated with the vehicle propylene glycol only. No positive control data was included in the study for reliability check.

On Day 29, a diffuse skin reddening at the skin site exposed to 25% (v/v) propane-1,2-diyl diacetate was observed in two animals (10.5%). The complete disappearance of the observed skin reddening 24 h later might indicate that the effects were not due to sensitisation. No further skin reactions were observed.

In summary, only two animal of the treatment group (10.5%) showed a positive result for skin sensitisation and thus propane-1,2-diyl diacetate (CAS 623-84-7) was considered to be not sensitising.

 

Conclusion for skin sensitisation

The structurally related source substance propane-1,2-diyl diacetate (CAS 623-84-7) showed no skin sensitisation potential in guinea pigs. Based on this result, no skin sensitisation potential for ethylene diacetate (CAS 111 -55 -7) was identified.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

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