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Diss Factsheets

Administrative data

Description of key information

In an in vivo test according to OECD 404, the skin of 3 male New Zealand White rabbits was exposed to 0.5 g of the substance under semi-occlusion during 4 hours. No signs of irritation (erythema and oedema) were observed at 1, 24, 48 and 72 hours after removal of the dressing. Therefore it is concluded that the substance is not irritating or corrosive to the skin.

In an eye irritation test according to OECD 405, the substance (0.1 mL) was installed in the eye of 3 male rabbits. Observations after 1, 24, 72, 48 and 72 hours and 7 days were indicative for irritation to the eyes. Based on effects on the conjunctivae the substance needs to be classified for eye irritation (cat 2).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 February 2007 to 24 March 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Qualifier:
according to guideline
Guideline:
other: JMAFF
Version / remarks:
12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Strain: Albino rabbit, New-Zealand White (SPF quality)
- Age at study initiation: at least 6weeks
- Weight at study initiation: 1450-1907 g
- Housing: individually in cages with perforated floors (Scanburg, Danmark)
- Diet: Pelleted rabbit diet ad libitum (K-H, SSNIFF, Soest, Germany)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0-22.5 ˚C
- Humidity (%): 40-58%
- Air changes (per hr): ca 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0,5 g moistened with 0.7 mL water

Duration of treatment / exposure:
4 hours
Observation period:
at 1, 24, 48 and 72 hours after removal of the dressing
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2x3 cm
- % coverage: 10%
- Type of wrap if used: semi-occlusive (mettaline patch mounted with micropore tape)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with water
- Time after start of exposure: after 4 hours

OBSERVATION TIME POINTS : at 1, 24, 48 and 72 hours after removalof the dressing

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 hour
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: i hour
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 hour
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1 hour
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
no irritant or corrosive effects observed
Other effects:
No effects on bodyweight gain. No toxic effects.

Animal no 1 2 3
1 24 48 72 1 24 48 72 1 24 48 72
erythema 0 0 0 0 0 0 0 0 0 0 0 0
oedema 0 0 0 0 0 0 0 0 0 0 0 0
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not irritating or corrosive to the skin
Executive summary:

In an in vivo test according to OECD 404, the skin of 3 male New Zealand White rabbits was exposed to 0.5 g of the substance under semi-occlusion during 4 hours. No signs of irritation (erythema and oedema) were observed at 1, 24, 48 and 72 hours after removal of the dressing. Therefore it is concluded that the substance is not irritating or corrosive to the skin.

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:
experimental study
Adequacy of study:
key study
Study period:
12 March 2007 to 17 April 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
according to guideline
Guideline:
other: JMAFF
Version / remarks:
12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Strain: Albino rabbit, New-Zealand White (SPF quality)
- Age at study initiation: at least 6 weeks
- Weight at study initiation: 1292-1564 g
- Housing: individually in cages with perforated floors (Scanburg, Danmark)
- Diet: Pelleted rabbit diet ad libitum (K-H, SSNIFF, Soest, Germany)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0-22.9˚C
- Humidity (%): 31-62%
- Air changes (per hr): ca 15/h
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL (54.2-46.2mg)
Duration of treatment / exposure:
NA
Observation period (in vivo):
7 days (assessment after 1, 24, 48 and 72 hours and after 7 days)
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: after 24 hours 2% fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
fluorescence area percentage 0%
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of mild irritation
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
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:
0
Remarks on result:
no indication of irritation
Remarks:
fluorescence area percentage 0%
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of mild irritation
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
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:
0
Remarks on result:
no indication of irritation
Remarks:
fluorescence area percentage 0%
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.66
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
the substance is a mild irritant to the eyes
Other effects:
After 1 hour remnants of the substance were found in the eyes of all three rabbits.
No effects on bodyweight gain. No toxic effects.

Animal no 1 2 3
1 24 48 72 7 1 24 48 72 7 1 24 48 72 7
cornea  0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
iris 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
conjunctivae                              
redness 2 3 2 2 0 2 3 2 2 0 2 2 2 1 0
chemosis 1 1 1 1 0 1 1 0 0 0 1 1 0 0 0
discharge 1 1 1 0 0 1 1 0 0 0 1 1 0 0 0
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The substance is irritating to the eyes
Executive summary:

In an eye irritation test according to OECD 405, the substance (0.1 mL) was installed in the eye of 3 male rabbits. Observations after 1, 24, 72, 48 and 72 hours and 7 days were indicative for irritation to the eyes. Based on effects on the conjunctivae the substance needs to be classified for eye irritation (cat 2).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the available information the substance needs to be classified as eye irritant (H319) according to EU Regulation 1272/2008 (CLP). No classification for skin irritation is considered necessary.