Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent

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

Resultsopen allclose all
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
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
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
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