Registration Dossier

Administrative data

Description of key information

Based on skin (OECD 404) and eye irritation (OECD 405) 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other: GLP compliant guideline study, available as unpublished report.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
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler; Offenbach / Main, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 2.70 - 2.98 kg
- Housing: Single housing in stainless steel wire mesh cages with grating. Floor area: 3000 cm2. No bedding in the cages.
- Diet: Kliba-Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, Switzerland. About 130 g per animal per day
- Water: Tap water, about 250 mL per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): Fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12 / 12 ( 6.00 a.m. - 6.00p.m. / 6.00 p.m. - 6.00 a.m.)
Type of coverage:
semiocclusive
Preparation of test site:
clipped
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 0.5 mL of the unchanged liquid test substance
Duration of treatment / exposure:
4 hour
Observation period:
72 hour
Number of animals:
3 (1 male and 2 female animals)
Details on study design:
- Application site: upper third of the back or flanks
- Readings: 1 h, 24 h, 48 h and 72 h after removal of the test patches
- A check for general observations and mortality was made twice each working day and once on weekends and on public holidays

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hour
Irritation parameter:
erythema score
Basis:
animal: 1-3
Time point:
other: mean 24-48-72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 1-3
Time point:
other: mean 24-48-72 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 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 semi-occlusive dressing. The cutaneous reactions were assessed immediately after removal of the patch and approximately 24, 48, 72 hours after removal. No skin reaction could be observed at any time point; thus the study was terminated 72 hours after removal of the dressings. 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
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
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 adult animals
- Weight at study initiation: male animal: 3.48 kg; female animals: 2.70 kg and 2.78 kg
- Housing: One animal per cage (type: stainless steel wire mesh cages with grating, floor area: 3000 cm2)
- Diet: Kliba-labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: tap water (about 250 mL/animal/day)
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h dark.
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Substance was not washed out
Observation period (in vivo):
72 hour
Number of animals or in vitro replicates:
3 (1 male and 2 female animals)
Details on study design:
- Readings: 1 h, 24 h, 48 h, and 72 h, after instillation
- A check for general observations and mortality was made twice each working day and once on weekends and on public holidays.
Irritation parameter:
cornea opacity score
Basis:
animal: 1-3
Time point:
other: mean 24-48-72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 1-3
Time point:
other: mean 24-48-72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal: #1 and # 3
Time point:
other: mean 24-48-72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24-48-72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal: #1 and #2
Time point:
other: mean 24-48-72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean 24-48-72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Under the conditions of the performed eye irritation study, the test substance was determined to be not 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. Three white Vienna rabbits were subjected to a single ocular application of 0.1 mL of the test substance on day 0. The mean score (24 to 72 hours) for irritation was calculated to be 0 (all animals) for corneal opacity and iris, 0, 0.3, and 0 for chemosis and 1, 1, and 0.7 for conjunctivae redness for animal 1, 2, and 3 respectively. The eye findings observed for chemosis were reversible within 48 hours and the findings for conjunctivae redness 72 hours after instillation. Based on these findings it is concluded that the test substance is 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:

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 semi-occlusive dressing (BASF 1994). The cutaneous reactions were assessed immediately after removal of the patch and approximately 24, 48, 72 hours after removal. No skin reaction could be observed at any time point; thus the study was terminated 72 hours after removal of the dressings. 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 (BASF 1994). Three white Vienna rabbits were subjected to a single ocular application of 0.1 mL of the test substance on day 0. The mean score (24 to 72 hours) for irritation was calculated to be 0 (all animals) for corneal opacity and iris, 0, 0.3, and 0 for chemosis and 1, 1, and 0.7 for conjunctivae redness for animal 1, 2, and 3 respectively. The eye findings observed for chemosis were reversible within 48 hours and the findings for conjunctivae redness 72 hours after instillation. Based on these findings it is concluded that the test substance is not irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
One skin irritation 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 obtained in the skin irritation test (according to OECD guideline 404) and the eye irritation test (according to OECD guideline 405), classification for skin 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.