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Description of key information

A skin irritation study in rabbits was performed according to EEC Directives 83/462 and 84/449. A mild irritating effect on the skin was observed with effects not fully resolving after 7 days.

An eye irritation study in rabbits was carried out as per EEC Directives 83/462 and 84/449. No irritating effects on the eye throughout the whole study was observed (7 days).

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:
15 Jun 1992 to 22 Jun 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
according to guideline
Guideline:
other: EEC Directives 83/467 and 84/449
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Conelli - Arona
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: stainless steel cages
- Diet: pellet complete diet
- Water: Purified water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 15 Jun 1992 To 22 Jun 1992
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Concentration: 100%
Duration of treatment / exposure:
4 hours
Observation period:
0, 24, 48, and 72 hours, and 5 and 7 days after removal of the patches.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: 2.5 x 2.5 cm gauze pads secured by thin bands of adhesive wrap, then covered with rubberized cloth.

SCORING SYSTEM
- Draize
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0.62
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.667
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: #2, #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: #5, #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Erythema (maximum score of 4) was seen in all animals at the 24 hour observation. In 3 of the animals, the erythema persisted throughout the experiment, and was not fully resolved by the end of the experiment on day 7. Oedema was seen in one animal at the 24 hour observation only.

Table 1: Results of Skin Irritation Study

Time after patch removal

Animal

Erythema

1

2

3

4

5

6

Mean

1 hr

0

0

0

0

0

0

0.00

24 hrs

2

1

2

1

1

1

1.33

48 hrs

2

1

1

1

1

1

1.17

72 hrs

1

1

1

1

1

1

1.00

5 days

1

1

1

1

1

1

1.00

7 days

0

0

1

0

1

1

0.50

Oedema

1 hr

0

0

0

0

0

0

0.00

24 hrs

1

0

0

0

0

0

0.17

48 hrs

0

0

0

0

0

0

0.00

72 hrs

0

0

0

0

0

0

0.00

5 days

0

0

0

0

0

0

0.00

7 days

0

0

0

0

0

0

0.00
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance caused only mild irritation, however, symptoms were not fully resolved by the end of the experiment.
Executive summary:

This study examined the potential of the test substance to cause skin irritation. Six rabbits were exposed to undiluted test substance on shaved skin for 4 hours. After the exposure the animals were scored for skin irritation, and were scored again at 24, 48, and 72 hours after end of exposure. Since symptoms were not fully resolved, further observations were made at 5 and 7 days after end of exposure. At the 24 hour observation, all animals showed signs of erythema (maximum score of 2), and one animal showed signs of oedema (score of 1). There were no signs of oedema in any animal at the 48 hour observation. Erythema persisted in all animals through day 5, and in 3 of the animals, erythema was not fully resolved at the end of the experiment on day 7. Though all symptoms of irritation were mild, the irritation was not fully reversible within the study period.

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:
15 Jun 1992 to 22 Jun 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
according to guideline
Guideline:
other: EEC Directives 83/467 and 84/449
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Conelli - Arona
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: stainless steel cages
- Diet: pellet complete diet
- Water: filtered tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 15 Jun 1992 to 22 Jun 1992
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 100%
Duration of treatment / exposure:
7 days
Observation period (in vivo):
1, 24, 48, and 72 hours, and 7 days after start of exposure
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM:
- Draize

Irritation parameter:
overall irritation score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
110
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
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, #2, #3, #4, #5, #6
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, #2, #3, #4, #5, #6
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, #2, #3, #4, #5, #6
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 irritation or corrosion were seen in any animal during any of the observations.

Table 1: Results of Eye Irritation Study - Mean Scores                  

Observation

Cornea

Iris

Conjunctiva (Redness)

Conjunctiva (Chemosis)

1 hr

0

0

0

0

24 hrs

0

0

0

0

48 hrs

0

0

0

0

72 hrs

0

0

0

0

7 days

0

0

0

0
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not an eye irritant.
Executive summary:

This study examined the potential of the test substance to cause eye irritation. 0.1 mL of test substance was placed in one eye of 6 rabbits. The untreated eyes served as controls. The eyes were examined at 1, 24, 48, and 72 hours, and 7 days after start of exposure for signs of irritation. No signs of irritation were seen in any animal at any observation. The test substance is considered no irritating to eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation study:

This study examined the potential of the test substance to cause skin irritation. 6 rabbits were exposed to undiluted test substance on shave skin for 4 hours. After the exposure the animals were scored for skin irritation, and were scored again at 24, 48, and 72 hours after end of exposure. Since symptoms were not fully resolved, further observations were made at 5 and 7 days after end of exposure. At the 24 hor observation, all animals showed signs of erythema (maximum score of 2), and one animal showed signs of oedema (score of 1). There were no signs of oedema in any animal at the 48 hour observation. Erythema persisted in all animals through day 5, and in 3 of the animals, erythema was not fully resolved at the end of the experiment on day 7. Though all symptoms of irritation were mild, the irritation was not fully reversible within the study period.

Eye irritation study

This study examined the potential of the test substance to cause eye irritation. 0.1 mL of test substance was placed in one eye of 6 rabbits. The untreated eyes served as controls. The eyes were examined at 1, 24, 48, and 72 hours, and 7 days after start of exposure for signs of irritation. No signs of irritation were seen in any animal at any observation. The test substance is considered not irritating to eyes.

Justification for classification or non-classification

Based on the available information, classification for skin and eye irritation is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.