Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin:

In a skin irritation assay according to EU method B.4 in rabbit (Huntingdon, ECHA RSS, 2017), no skin irritating properties were determined.

Eye:

In an eye irritation assay according to EU method B.5 in rabbit (Huntingdon, ECHA RSS, 2017), no eye irritating properties were determined.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
as cited in 84/449/EEC
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 500 mg
Duration of treatment / exposure:
4 h
Observation period:
72 hours
Number of animals:
3
Details on study design:
500 mg test substance was moistened with 0.5 mL of distilled water and was covered with a 6.25 cm² gauze pad.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of skin irritation were observed at any time during the study.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance did not show any dermal irritation after a single semi occlusive application to the intact rabbit skin for 24 hours.
Executive summary:

In a primary dermal irritation study according to EU method B.4 (Huntingdon, ECHA RSS, 2017), young adult New Zealand White rabbits were dermally exposed to 0.5 mg of the unchanged test substance under a semi occlusive dressing for 24 hours. Animals were then observed for 72 hours. Irritation was scored by the method of Draize et al. (1960). No signs of skin irritation were observed at any time during the study. In this study, the test substance is not a dermal irritant.

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
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
An in vivo study was performed before 1 June 2008 for the registration of WinCon-2 under the old chemical legislation. This data is no longer protected and therefore it was retrieved from ECHA in 2017 as an Article 25(3) request.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL (equivalent to 40 mg)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: According to Draize et al. (1960)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
In all three animals a very slight conjunctival irritation was observed after 1 h. This effect was fully reversible within 24 h.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was considered to be not irritating to the eye of New Zealand White rabbits in a eye irritation test according to EU Method B.5.
Executive summary:

In a primary eye irritation study according to EU method B.5 (Huntingdon, ECHA RSS, 2017), 0.1 mL (equivalent to 40 mg) of the test substance was instilled into the conjunctival sac of the eye of three young adult New Zealand White rabbits. Animals were then observed for 72 hours. Irritation was scored by the method of Draize et al. (1960).

Very slight conjunctival irritation was observed at one hour after treatment, but had resolved by the end of the first day. No other eye effects were noticeable at the end of the observation period. In this study the test substance is not regarded as eye irritant.

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
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
An in vivo study was performed before 1 June 2008 for the registration of WinCon-2 under the old chemical legislation. This data is no longer protected and therefore it was retrieved from ECHA in 2017 as an Article 25(3) request.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In accordance with Article 25(3) of the REACH Regulation the robust study summaries submitted 12 years previously, are used for the purpose of the registration.

Skin irritation

Key study

In a primary dermal irritation study according to EU method B.4 (Huntingdon, ECHA RSS, 2017), young adult New Zealand White rabbits (3 animals) were dermally exposed to 0.5 mg of the unchanged test substance under a semi-occlusive dressing for 24 hours. Animals were then observed for 72 hours. Irritation was scored by the method of Draize et al. (1960). No signs of skin irritation were observed at any time during the study. In this study, the test substance did not show skin irritating properties.

Supporting study

In a primary dermal irritation study according to EU method B.4 (Pharmaco-LSR, ECHA RSS, 2017), young adult New Zealand White rabbits were dermally exposed to 0.5 mg of the unchanged test substance under a semi occlusive dressing for 4 hours. Animals were then observed for 72 hours. Irritation was scored by the method of Draize et al. (1960). No signs of skin irritation were observed at any time during the study. In this study, the test substance did not show skin irritating properties

Eye irritation

Key study

In an eye irritation assay according to EU method B.5 in rabbit (New Zealand White) (Huntingdon, ECHA RSS, 2017), the eye irritating properties of the test substance were determined. The test substance was tested on three animals. Iris and cornea opacity score were 0.0 (no signs of irritation). In all three animals a very slight conjunctival irritation was observed after 1 h. This effect was fully reversible within 24 h. Accordingly, the test substance was considered to be not irritating to the eye.

Supporting study

In a primary eye irritation study according to EU method B.5 (Pharmaco-LSR, ECHA RSS, 2017), 100 mg of the test substance was instilled into the conjunctival sac of one eye of three young adult New Zealand White rabbits. Animals were then observed for 8 days. Irritation was scored by the method of Draize et al. (1960).

Animal No 1 showed slight conjunctivae redness as well as diffuse areas of opacity. Furthermore slight effects on the iris and some swelling of the eye above the normal were observed. In addition to the effects scored, 2 animals showed slight conjunctival discharge during the first 24 hours post administration. There were no effects noticeable by study day 8. Thus, the test substance is not regarded as eye irritant.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on eye and skin irritation/corrosion, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.