Reaction products of ethylene glycol, epichlorohydrin and sodium hydroxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Remarks:

This experimental study was performed only for one constituent (2,2'-[ethylenebis(oxymethylene)]bisoxirane, CAS 2224-15-9, EC 218-746-2) of the UVCB substance.

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

(non-GLP, only limited information on material and methods given, no body weights specified, animals were observed for only 72 h)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Draize Testing method (Draize JH et al., J. Pharm. Exp. Ther. 82: 377-390, 1944; Draize JH, Assoc. Food Drugs Officials of the United States: 46-49, Topeka Kansas, 1965) as prescribed by the FDA (in The Federal Register 38 No.187 §15000.41, USA)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[ethylenebis(oxymethylene)]bisoxirane

EC Number:

218-746-2

EC Name:

2,2'-[ethylenebis(oxymethylene)]bisoxirane

Cas Number:

2224-15-9

Molecular formula:

C8H14O4

IUPAC Name:

2,2'-[ethane-1,2-diylbis(oxymethylene)]dioxirane

Test animals

Species:

rabbit

Strain:

other: Albino rabbit

Test system

Type of coverage:

other: not specified in the report but occlusive assumed since Draize test.

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL or 0.5 g

Duration of treatment / exposure:

24 h

Observation period:

24 and 72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: The dorsal area of the trunk
- Type of wrap: A square patch of surgical gauze (2.54 x 2.54 cm) was used
- Testing was performed on intact and abraded skin

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, 4 and 5

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 2

Irritation parameter:

erythema score

Basis:

animal: #2, 3 and 6

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 3

Irritation parameter:

edema score

Basis:

animal: #1, 2, 3 and 6

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 4

Irritation parameter:

edema score

Basis:

animal: #4 and 5

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Irritant / corrosive response data:

Erythema and edema were observed in the intact skin of all 6 rabbits. 3/6 rabbits showed an erythema score of 2 at the 24-h reading time point, which increased to a score of 3 at the 72-h reading time point. 3/6 rabbits showed an erythema score of 3, which increased to a score of 4 at the 72-h reading time point.
An edema score of 2 was observed in 4/6 animals at the 24-h reading time point, persisting at the 72-h reading time point. 2/6 rabbits showed an edema score of 1 at the 24-h reading time point, which increased to a score of 2 at the 72-h reading time point.
Since the study was stopped after 72 h, no clear assessment is feasible with respect to reversibility.

Other effects:

The findings observed in the experiment performed on abraded skin revealed similar results with a slightly more severe tendency for edema formation.

Any other information on results incl. tables

Table 1: Results of skin irritation study (intact skin)

Observation time	Rabbit no.
	1		2		3		4		5		6
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
24 h	2	2	3	2	3	2	2	1	2	1	3	2
48 h	No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)
72 h	3	2	4	2	4	2	3	2	3	2	4	2

Table 2: Calculation of mean scores (intact skin)

	Rabbit no.
	1		2		3		4		5		6
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
Mean value 24 + 48 + 72 h*	2,3	2,0	3,3	2,0	3,3	2,0	2,3	1,3	2,3	1,3	3,3	2,0

*No 48 h data are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h).

Applicant's summary and conclusion

Interpretation of results:

other: Skin Irrit. 2, H315 according to Regulation (EC) No. 1272/2008

Conclusions:

Based on the conducted study and the resulting scores, classification as skin irritant, Cat. 2, H315 is warranted.

CLP: Skin Irrit. 2, H315