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Diss Factsheets

Administrative data

Description of key information

Skin Irritation: not irritating; BASF 2000, OECD Guideline Study
Eye Irritation: not irritating; BASF 2000, OECD Guideline Study

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)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: 3.8 - 4.0 kg
- Housing: Single housing in stainless steel wire mesh cages with grating
- Diet: Kliba-Labordiaet, Provimi Kuba SA, Kaiseraugst, Switzerland ad libitum
- Water: Tap water ad libitum.
- Acclimation period: at least 1 week before study start

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%.
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
moistened with water
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the unchanged solid test substance (moistened with aqua bidest.; because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physiological conditions as possible).
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Upper third of the back or flanks; application area: 2.5 x 2.5 cm
- Type of wrap if used: The test substance has been covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull(R) stretoh (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end application period with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: 4h

SCORING SYSTEM: according to OECD guideline 404
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No skin findings were noted in all animals.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Considering the described cutaneous reactions as well as the average score for irritation, the test substance does not give indication of an irritant property to the skin under the test conditions chosen.
Executive summary:

The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 g of the test substance to the intact skin of 3 White New Zealand rabbits for 4 hours under semiocclusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed approximately 1, 24, 48 and 72 hours after

removal of the patch. No skin findings were noted in all animals; thus the study was terminated after 72 hours. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for erythema and for edema. Considering the described cutaneous reactions as well as the average score for irritation, the test substance does not give indication of an irritant property to the skin under the test conditions chosen.

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)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: 3.75 - 4.0 kg
- Housing: Single housing in stainless steel wire mesh cages with grating
- Diet: Kliba-Labordiaet, Provimi Kuba SA, Kaiseraugst, Switzerland ad libitum
- Water: Tap water ad libitum.
- Acclimation period: at least 1 week before study start

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- 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): 2 x 0.1 ml bulk volume (about 2 x 9 mg of the comminuted test substance)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the substance was washed out with tap water
- Time after start of exposure: about 24 hours after application (before 24 hour reading).

SCORING SYSTEM: according to OECD guideline 405
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.4
Max. score:
2
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Moderate erythema, slight swelling of the eye lids and slight discharge was 0 observed in all animals 1 hour after application. The conjunctival reactions were reversible in all animals within 72 hours after application at latest.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Considering the described ocular reactions as well as the average score for irritation, the test substance does not give indication of an irritant property
to the eye under the conditions chosen.
Executive summary:

The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed in 3 White New Zealand rabbits. The animals were subjected to a double ocular application of 0.1 ml bulk volume (about 9 mg) of the test substance, corresponding to an amount of 18 mg administered. About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application. Moderate erythema, slight swelling of the eye lids and slight discharge was 0 observed in all animals 1 hour after application. The conjunctival reactions were reversible in all animals within 72 hours after application at latest. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, for iris and for chemosis and 0.4 for conjunctival redness. Considering the described ocular reactions as well as the average score for irritation, the test substance does not give indication of an irritant property to the eye under the test conditions chosen.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

A GLP-compliant skin irritation test was performed with three New Zealand White rabbits according to OECD 404 (Notox, 1999). A 4-hour semiocclusive exposure to approximately 0.5 g of the test material moistened with water produced no effects during the observation period of 3 days on the treated sites of the animals. No skin findings were noted in all animals; thus the study was terminated after 72 hours. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for erythema and for edema. In conclusion, considering the described cutaneous reactions as well as the average score for irritation, the test substance does not give indication of an irritant property to the skin under the test conditions chosen.

Eye

A GLP-compliant eye irritation test was performed with three New Zealand White rabbits according to OECD 405 (BASF, 2000).

The animals were subjected to a double ocular application of 0.1 ml bulk volume (about 9 mg) of the test substance, corresponding to an amount of 18 mg administered. About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application. Moderate erythema, slight swelling of the eye lids and slight discharge was 0 observed in all animals 1 hour after application. The conjunctival reactions were reversible in all animals within 72 hours after application at latest. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, for iris and for chemosis and 0.4 for conjunctival redness. In conclusion, considering the described ocular reactions as well as the average score for irritation, the test substance does not give indication of an irritant property to the eye under the test conditions chosen.


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

Justification for selection of eye irritation endpoint:
GLP-compliant guideline study

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for skin/eye irritation is not warranted under Directive 67/548/EEC.

 

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

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for skin/eye irritation is not warranted under Regulation (EC) No.1272/2008.