Registration Dossier

Administrative data

Description of key information

Based on skin (OECD 404, GLP) and eye irritation (OECD 405, GLP) studies performed in vivo, it can be concluded that the test substance is not corrosive or irritating to the skin and eye.

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:
other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Reference:
Composition 0
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, FRG
- Age at study initiation: young adults
- Weight at study initiation: 3.26 - 3.66 kg
- Housing: single housing, stainless steel wire mesh cages with grating, floor area 3000 cm2; no bedding in the cages, sawdust in the waste trays
- Diet: 130 g/day, Kliba-Labordiaet 341, Klingentalmuehle AG Kaiseraugst, Switzerland
- Water: 250 mL/day tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air: central air-conditioning
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
The test patches (2.5 x 2.5 cm) were moistened with a dose of 0.5 mL of the undiluted liquid test substance.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm, upper third of the back or flanks
- Type of wrap if used: test patch (idealbinde, pfaelzische verbandstoff-fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing: lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM: erythema and eschar formation, and edema formation according to OECD 404 guideline 1, 24, 48, and 72 hours after removal of the patch.

General observations: A check was made twice each workday and once on saturdays, sundays and on public holidays for general observations and for any dead or moribund animals.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Under the conditions of the test the substance is considered to be not corrosive or irritating to the skin.
Executive summary:

The potential to cause acute dermal irritation or corrosion was assessed in a OECD 404 guideline study (in compliance with GLP) by a single topical application of 0.5 mL of the test substance to the intact skin of 3 white Vienna rabbits for 4 hours under semiocclusive dressing. The average score (24 to 72 hours) for irritation was calculated to be 0.1 for erythema and 0.0 for edema. The findings were reversible between 24 and 48 hours after removal of the patches. It was concluded that the test substance was not irritating 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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Reference:
Composition 0
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, FRG
- Age at study initiation: young adults
- Weight at study initiation: 3.66 - 3.85 kg
- Housing: single housing, in stainless steel wire mesh cages with grating, floor area 3000 cm2; no bedding in the cages, sawdust in the waste trays
- Diet: 130 g/day of Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland
- Water: 250 mL tap water/day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 -70
- Air: central air-conditioning
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 mL to the conjunctival sac of the right eyelid
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
- Both eyes were examined before application of the test substance for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used in the study.
- Weight determination: shortly before application of the test substance
- The test substance was not washed out.
- Readings: 1, 24, 48 and 72 h after application
- A check for general observation and mortality was made twice each working day and once on weekends and on public holidays.
- SCORING SYSTEM: Cornea, conjunctivae, chemosis and iris effects as stated in the OECD 405 guideline
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Under the conditions of the test the substance is considered to be not corrosive or irritating to the eye.
Executive summary:

The potential to cause damage to the conjunctiva, iris or cornea was assessed in an OECD 405 guideline study (in compliance with GLP) in 3 white Vienna rabbits subjected to a single ocular application of 0.1 mL of the test substance on day 0. The average score (24 to 72 hours) for irritation was calculated to be 0 for corneal opacity, iris, chemosis, and 0.9 for conjunctivae redness (in which two animals had a score of 1 and one a score of 0.7). The findings were reversible withing 72 hours after application. It was concluded that the test substance was not irritating to the eye.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion

The potential to cause acute dermal irritation or corrosion was assessed in a OECD 404 guideline study (in compliance with GLP) by a single topical application of 0.5 mL of the test substance to the intact skin of 3 white Vienna rabbits for 4 hours under semiocclusive dressing (BASF 1994). The average score (24 to 72 hours) for irritation was calculated to be 0.1 for erythema and 0.0 for edema. The findings were reversible between 24 and 48 hours after removal of the patches. It was concluded that the test substance was not irritating to the skin.

Eye irritation

The potential to cause damage to the conjunctiva, iris or cornea was assessed in an OECD 405 guideline study (in compliance with GLP) in 3 white Vienna rabbits subjected to a single ocular application of 0.1 mL of the test substance on day 0 (BASF 1994). The average score (24 to 72 hours) for irritation was calculated to be 0 for corneal opacity, iris, chemosis, and 0.9 for conjunctivae redness (in which two animals had a score of 1 and one a score of 0.7). The findings were reversible withing 72 hours after application. It was concluded that the test substance was not irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
One skin irritation/corrosion study is available. This study is adequate for covering this endpoint.

Justification for selection of eye irritation endpoint:
One eye irritation study is available. This study is adequate for covering this endpoint.

Justification for classification or non-classification

Based on the results observed in the skin and eye irritation and corrosion tests, classification for skin irritation / corrosion and eye irritation is not warranted in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.