Registration Dossier

Administrative data

Description of key information

The test item is non irritating to skin. The test item shows severe, non reversible eye damage.

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:
1989-11-13 to 1989-11-30
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study similar to guideline but without GLP
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted May 12, 1981
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: GAUKLER; D-6050 OFFENBACH/MAIN, Germany
- Weight at study initiation: 2.46 kg (males), 2.58 kg (females)
- Housing: 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; FIRMA KLINGENTALMUEHLE AG, CH-4303 KAISERAUGST, SWITZERLAND)
- 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
- Photoperiod: 12 H/12 H (6.00 - 18.00 HOURS/18.00 - 6.00 HOURS)
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL of the undiluted test substance
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 (2 males, 1 female)
Details on study design:
TEST SITE
- Area of exposure: UPPER THIRD OF THE BACK OR FLANKS, 2.5 cm X 2.5 cm
- Type of wrap if used: TEST PATCHES WERE SECURED IN POSITION WITH A POROUS DRESSING ( FOUR LAYERS OF ABSORBENT GAUZE + POROUS BANDAGE).

REMOVAL OF TEST SUBSTANCE
- Washing: AT THE END OF THE EXPOSURE PERIOD WITH LUTROL AND LUTROL/WATER (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD Guideline 404
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 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:
1989-11-27 to 1989-12-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study similar to guideline but without GLP
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted May 12th, 1981
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: SAVO/MED.VERSUCHSTIERZUCHTEN GMBH, 7964 Kisslegg/ Algäu Germany
- Weight at study initiation: 3.31 kg (male), 3.06 kg (female)
- Housing: 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; FIRMA KLINGENTALMUEHLE AG CH-4303 KAISERAUGST, SWITZERLAND)
- Water: ABOUT 250 ML TAP WATER PER ANIMAL PER DAY

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 DEGREES CELSIUS
- Humidity: 30 - 70 %
- Photoperiod: 12 H/12 H (6.00 - 18.00 HOURS/ 18.00 - 6.00 HOURS)
- Acclimatisation: AT LEAST 8 DAYS

IN-LIFE DATES: no data given
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as negative control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL (unchanged)


Duration of treatment / exposure:
single treatment
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3 rabbits (1 male, 2 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: According to OECD Guideline 405
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
other: findings could not be read - Ulcus corneae
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 3 d
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
2
Reversibility:
other: findings could not be read - Ulcus corneae
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 8 d
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The potential of the test item to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 mL of the test substance to the intact skin of 3 white Vienna White rabbits for 4 hours under semiocclusive dressing (BASF SE 1990). The average score (24 to 72 hours) for irritation was calculated to be 0.1 for erythema and 0.0 for edema. The effects were fully reversible within 72 h; thus the study was terminated after 72 hours. Under the test conditions chosen and considering the described findings the test item does not give indication of an irritant property to the skin.

Eye irritation

The potential of the test item to cause damage to the eye was assessed in 3 white New Zealand rabbits, subjected to a single ocular application of 0.1 mL of the test substance (BASF SE 1990). The average score (24 to 72 hours) for irritation was calculated to be 1.0 for corneal opacity, 0.4 for iris, 1.7 for chemosis and 2.0 for conjunctivae redness. Some effects (corneal opacity) were not fully reversible after 21 days. Under the test conditions chosen and considering the described findings, the test item is classified as severely eye damaging.


Justification for selection of skin irritation / corrosion endpoint:
Key study was selected for selection, study is similar to guideline study.

Justification for selection of eye irritation endpoint:
Key study was selected for selection, study is similar to guideline study.

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the results, classification for skin irritation is not warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.

Based on the results of the in vivo eye irritation study, the test substance is classified as Xi, R41 (risk of serious damage to eyes) according to the criteria of EU Directive 67/548/EEC and as eye damage cat. 1, H318 (Causes serious eye damage) according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.