Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin: Under the test conditions chosen the test substance does not give indication of an irritant property to the skin.
Eye: Under the test conditions chosen the test substance does not give indication of an irritant property to the 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 and guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler; D-W6050 Offenbach, Germany
- Age at study initiation: young adult animals
- Sex: male
- Weight at study initiation: 2.93, 2.86, 3.12 kg
- Housing: single housing in cage made of stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm
- Diet: KLIBA Labordiät 341; Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0,5 mL

Duration of treatment / exposure:
4 hours
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 * 2.5 cm
- Type of wrap if used: The test patch was secured in position with a semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was removed at the end of the exposure period with Lutrol(R) (Lutrol (R) E 400= Polyethylenglycol DAB, BASF AG) and Lutrol(R)/ water (1 : 1).
- Time after start of exposure: 4 h exposure period

SCORING SYSTEM: according to OECD Guideline 404 (adopted May 12, 1981) and EEC L 251, B.4. (Sept. 19, 1984)
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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: GAUKLER; D-6050 Offenbach /Main, Germany
- Age at study initiation: young adult animals,
-Sex: males
- Weight at study initiation: 2.74 kg, 3.17 kg, 3.04 kg
- Housing: single housing in steel cage with wire mesh walk floors, floor area 40 cm * 51 cm
- Diet: about 130 g KLiba - Labordiät 341 per animal per day
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL


Duration of treatment / exposure:
24 h
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
According to OECD guideline 405 and EU method B5

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:
0.33
Max. score:
2
Reversibility:
fully reversible within: 8 days
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:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h, 48 h, 72 h
Score:
0.33
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 h, 48 h, 72 h
Score:
1.33
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:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 h, 48 h, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
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:

The potential of the test substance 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 rabbits for 4 hours under semiocclusive dressing. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for erythema and 0.0 for edema. As no skin reaction was observed, the study was terminated after 72 hours. Under the test conditions chosen and considering the described findings the test substance does not give indication of an irritant property to the skin.

Eye:

The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed in 3 White Vienna rabbits, subjected to a single ocular application of about 0.1 mL of the test substance on day 0.

The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, 0.1 for iris, 1.2 for conjunctivae redness and 0.6 for chemosis. The findings were reversible in all animals within 8 days, thus the study was terminated after 8 days. For all animals the mean cornea score over the time points 24 h, 48 h and 72 h was 0, the mean iris score for animal 1 was 0.33, for animal 2 and 3 it was 0. The mean conjunctivae scores were 2 (animal 1), 0.33 (animal 2) and 1.33 (animal 3). The mean chemosis scores were 1.33 (animal 1), 0 (animal 2) and 0.33 (animal 3).

Under the test conditions chosen and considering the described findings the test substance does not give indication of an irritant property to the eye.


Justification for selection of skin irritation / corrosion endpoint:
GLP conform guideline study

Justification for selection of eye irritation endpoint:
GLP conform guideline study

Justification for classification or non-classification

The test substance was not irritating to the skin and eye in vivo.

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