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Diss Factsheets

Administrative data

Description of key information

Skin: The test material was not irritant to rabbit's skin under test conditions chosen.
Eye: The test material was not irritant to the rabbit's eye under test conditions chosen.

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:
1984-11-27 and 1985-03-04
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP conform study, but according to OECD guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main
- Age at study initiation: no data
- Weight at study initiation: 3.10 kg (mean)
- Housing: individually in cage made of stainless steel with wire mesh walk floors (floor area: 40 cm x 51 cm)
- Diet: Kliba 341, 4 MM; Firma Klingentalmuehle AG, CH-4303 Kaiseraugust, Switzerland; about 130 g per animal per day
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: Wetting of the test patch with the undiluted substance. And thus about 0.5 mL of the test liquid is absorbed.

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap: four layers of absorbent gauze + porous bandage

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lutrol and lutrol/water (1:1)
- Time after start of exposure: at the end of the exposure period (4 h)

SCORING SYSTEM: according to OECD guideline
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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:
1985-01-28 and 1985-03-04
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: according to OECD guideline, but not GLP conform
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main
- Age at study initiation: no data
- Weight at study initiation: 2.92 kg (male), 3.04 kg (female)
- Housing: individually in cage made of stainless steel with wire mesh walk floors (floor area: 40 cm x 51 cm)
- Diet: about 130 g per animal per day (Kliba 341, 4 MM, Klingeltalmuehle AG, CH-4303 Kaiseraugust)
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 -70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
Single application to the conjunctival sac of the right eyelid.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
2 males, 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: none

SCORING SYSTEM: according to OECD scoring system

TOOL USED TO ASSESS SCORE: no data
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4

All animals showed redness and sweling at 1 hour after application.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

An acute skin irritation/corrosion study was conducted according to OECD guideline 404 on three male White Vienna rabbits to determine the irritant or corrosive potency of the test substance. At least 15 hours before the beginning of the study the fur of each rabbit was clipped. The test patch (2.5 x 2.5 cm) was moistened with the undiluted substance and thus about 0.5 mL of the test liquid is absorbed. The test patch was applied to the upper third of the back or flanks and was secured in position with four layers of absorbent gauze and porous bandage for 4 hours. The skin reactions were evaluated 30 - 60 minutes after removal of the test patches and 24 h, 48 h and 72 h after the beginning of the application. Since the mean values of the recordings 24 h, 48 h and 72 h for both erythema and edema were scored zero for all animals, the test substance was determined to be non-irritating to the rabbit's skin.

Eye irritation

An acute eye irritation/corrosion study in White Vienna rabbits was performed in accordance to OECD guideline No. 405 to determine the irritant or corrosive potency of the test substance. Therefore, 0.1 mL of the test substance was placed into the conjunctival sac of the right eyelid of each animal. The untreated left eye served as negative control. The substance was not washed out. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of the test compound according to the OECD scoring system. The mean scores (over time points 24 h, 48 h, 72 h) for animal 1 as well as 2 were determined to be 0 for cornea, for iris, for conjunctivae redness and for chemosis. For animal 3, the mean scores were 0 for cornea, for iris, for chemosis and 0.3 for conjunctivae redness. All animals showed redness and sweling at 1 hour after application. Ocular reactions were fully reversible within 48 hours. Based on these results, the test substance was considered to be non-irritating to the rabbit's eye.


Justification for selection of skin irritation / corrosion endpoint:
One reliable study according to OECD guideline 404.

Justification for selection of eye irritation endpoint:
One reliable study according to OECD guideline 405.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.