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Diss Factsheets

Administrative data

Description of key information

The test item was not irritating to rabbits' skin in a GLP conform study according to OECD Guideline 404.

The test item was not irritating to rabbits' eye in a GLP conform study according to OECD Guideline 405.

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
Study period:
May 09, 1995 - May 16, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
31 July 1992
Deviations:
no
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: SAVO-Ivanovas, Kisslegg
- Age at study initiation: about 31 to 32 weeks
- Weight at study initiation: 3.81 (3.51 - 4.20) kg
- Housing: separately in cages type KK 017 (floor area: 75 x 54.5 = 4087 cm2 , height: 38 cm; manufacturer: Hulskamp) on metal grids
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 40 - 50


Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: aqua pro injectione
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g

VEHICLE
- Amount applied: some drops

Duration of treatment / exposure:
4 hours
Observation period:
1 hour, 24, 48, and 72 hours, and on a period of further 4 days
Number of animals:
3 (2 males and 1 female)
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: perforated polyethylene feil, which was kept in place by a leather sleeve

REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1 hour, 24, 48, and 72 hours, and on a period of further 4 days

SCORING SYSTEM:
- Method of calculation: According to OECD 404
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
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:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
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:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Other effects:
- Other adverse local effects: none
- Other adverse systemic effects: none
Interpretation of results:
GHS criteria not met
Conclusions:
The test item showed no skin irritation potential in the study according to OECD Guideline 404.
Executive summary:

To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of aqua pro injectione to ensure good contact to the skin, spread onto patches, and then applied to the intact skin of three previously shaven rabbits for a 4-hour period under semiocclusive conditions.

The first examination of the treated skin sites followed 1-hour after removal of the patches. Then, examinations were performed daily for further 7 days. Under the given experimental conditions no irritations in the treated areas were observed. Therefore, the test item is not considered to be irritating to skin.

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
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
Study period:
May 17 until May 24, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
24 Feb 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
31 July 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: about 32 to 33 weeks
- Weight at study initiation: 3.91 (3.74 - 4.03) kg
- Housing: separately in cages type KK 017 (floor area: 75 x 54.4 = 4087 cm2), height: 38 cm) on metal grids
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 18
- Humidity (%): 42 - 57

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g

Duration of treatment / exposure:
Eyelids were closed for about 30 seconds.
Observation period (in vivo):
1 hour after treatment, and then after 24, 48, 72 hours and so on for a period of further 4 days.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: none

SCORING SYSTEM: according to OECD Guideline

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
The conjunctivae showed redness (score 1) one hour after treatment in all 3 animals. Chemosis was observed one hour after instillation in animal 1 only.
Other effects:
- Lesions and clinical observations: none
- Ophthalmoscopic findings: none
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the available data obtained from a Guideline conform study according to OECD 405 performed under GLP conditions, the test item is not considered to be irritating to rabbits' eye.
Executive summary:

To test for primary eye irritation, the test material was instilled undamped into the conjunctival sac of rabbits.

The first examination of the eyes followed 1 hour after instillation. Then, examinations were performed daily for further 7 days.

The conjunctivae showed redness (score 1) one hour after treatment in all 3 animals. Chemosis was observed one hour after instillation in animal 1 only.

In all animals the individual mean scores (considering readings 24, 48, and 72 hours after instillation) of each animal were 0 for cornea opacity score, iris score and chemosis. In animal 1 the individual mean score (considering readings 24, 48, and 72 hours after instillation) was 0.33 for redness. Furthermore, no signs of systemic toxicity, no mortality and a normal body weight gain were observed. Signs of irritation were fully reversible. The untreated eyes were normal.

Under the conditions of the present study, the test item is not considered to be irritating to eye.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

To examine the skin irritation potential of the test item, the test material was applied to the intact skin of three rabbits for a 4 -hour period under semiocclusive conditions. Readings were performed 1 hour after patch removal and then daily for further 7 days. Under the experimental conditions no irritations in the treated areas were observed.

To test for primary eye irritation, the test material was instilled undamped into the conjunctival sac of rabbits. The first examination of the eyes followed 1 hour after instillation. Then, examinations were performed daily for further 7 days. In all animals the individual mean scores (considering readings 24, 48, and 72 hours after instillation) of each animal were 0 for cornea opacity score, iris score and chemosis. In animal 1 the individual mean score (considering readings 24, 48, and 72 hours after instillation) was 0.33 for redness. Under the conditions of the present study, the test item is not considered to be irritating to eye.

Justification for classification or non-classification

Based on the available data, the test item is not considered to be classified for skin and eye irritation according to Regulation (EC) No 1272/2008.