Registration Dossier

Administrative data

Description of key information

Three female rabbits were exposed to the substance during 4 hours under semi-occlusion. Examination of the skin for signs of oedema and erythema at 1, 24, 48 and 66 hours after removal of the dressing showed no irritation (all scores 0). The substance is non-irritant to the skin (NOTOX 1985).

Three female rabbits received 64 mg (0.1 mL) of the substance in the eye. The eyes were observed for signs of irritation after 1, 24, 48 and 72 hours and after 7 and 14 days. No effects were found on the cornea and the iris. The effects on the conjunctivae were limited and fully reversible. The substance is considered not irritating to the eyes (NOTOX 1985).

In an abstract of a study submitted to US-EPA, the substance was reported to be severly eye damaging (Kodak 1992)

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
last observation at 66 hours after removal of the patch instead of at 72 hours
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute Someren, The Netherlands
- Weight at study initiation: 2810 - 3150 g
- Housing: individually in Lurane cages with perforated floors
- Diet: standard diet ( LK01 Hope Farms Woerden) 100 g/d
- Water: tap water ad libitum
- Acclimation period: not defined

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 °C
- Humidity (%): 55-75%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: skin moistened with 0.5 mL water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL: 0.5 mg
Duration of treatment / exposure:
4 hours
Observation period:
66 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: metaline mounted on permeable tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with a water moistened tissue
- Time after start of exposure: at 4 hours

OBSERVATION TIME POINTS: 1, 24, 48 and 66 hours after removal of the dressing

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
other:
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
no irritant effects at any of the observations (score 0)

Animal no

1

2

3

1

24

48

66

1

24

48

66

1

24

48

66

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 non-irrtant to the skin
Executive summary:

Three female rabbits were exposed to the substance during 4 hours under semi-occlusion. Examination of the skin for signs of oedema and erythema at 1, 24, 48 and 66 hours after removal of the dressing showed no irritation (all scores 0). The substance is non-irritant 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:
25 March 1985 to 11 June 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute Someren, The Netherlands
- Weight at study initiation: 2761 - 3000 g
- Housing: individually in Lurane cages with perforated floors
- Diet: standard diet ( LK01 Hope Farms Woerden) 100 g/d
- Water: tap water ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 °C
- Humidity (%): 50-80%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12
Vehicle:
unchanged (no vehicle)
Remarks:
grounded before instillation
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 64 mg (0.1 mL)

VEHICLE: none
Duration of treatment / exposure:
NA
Observation period (in vivo):
at 1, 24, 48 and 72 hours and 7 and 14 days after instillation
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: at 24 and 48 h fluorescein staining was used
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: superficial epithelial corrosion of the cornea (10-20%) at 24 h after fluorescein treatment
Remarks:
no corneal damage at 72 h
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
1.4
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.4
Max. score:
3
Reversibility:
fully reversible within: 7 days

Animal no

1

2

3

1

24

48

72

7

14

1

24

48

72

7

14

1

24

48

72

7

14

cornea

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

iris

1

0

0

0

0

0

1

0

0

0

0

0

1

1

0

0

0

0

conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

redness

1

1

2

2

1

0

1

2

1

1

1

0

1

2

2

1

1

0

chemosis

3

2

2

1

0

0

2

2

1

1

0

0

3

2

1

1

0

0

 

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is considered non-irritant to the eyes
Executive summary:

Three female rabbits received 64 mg (0.1 mL) of the substance in the eye. The eyes were observed for signs of irritation after 1, 24, 48 and 72 hours and after 7 and 14 days. No effects were found on the cornea and the iris. The effects on the conjunctivae were limited and fully reversible. The substance is considered not irritating to the eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification

The substance does not need to be classified for skin irritation and eye irritation according to EC 1272/2008 (CLP)