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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment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: male animal: 2.8 kg; female animals: 2.99 kg and 2.74 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.
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 0.5 mL of the undiluted test substance.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
At least 24 hours before study start, the fur was removed by clipping the dorsal of the trunk of the animals; only animals with healthy intact skin have been used. The test substance was applied in a single dose to the intact untreated skin.
- 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 (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hour
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal: #2 and #3
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2, and #3
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Based on the results obtained in this study and under the test conditions the test substance is not irritating to the skin.
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 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 erythema was calculated to be 0.7, 0, and 0 for the three animals, respectively. The score for edema was 0 for all animals. The erythema observed in one animal was reversible within 72 hours after removal of the patch. Under the test conditions chosen and considering the described findings the test substnace does not give indication of an irritant property 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: mean body weight: 3.18 kg
- Housing: Single housing stainless steel wire mesh cages with grating, floor area : 3000 cm2
- Diet: Kliba-labordiaet 343, Klingentalmuehle AG 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°C
- Humidity (%): 30 - 70%
- Photoperiod: 12 h light and 12 h dark
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Substance was not washed out.
Observation period (in vivo):
15 d
Number of animals or in vitro replicates:
3
Details on study design:
- Readings: 1 h, 24 h, 48 h, 72 h, 8 d and 14 day 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, #2, and #3
Time point:
other: mean 24-48-72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, and #3
Time point:
other: mean 24-48-72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #1
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:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
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
Time point:
other: mean 24-48-72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean 24-48-72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean 24-48-72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
One female animal showed a contracted pupil at 1 hour after exposure
Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Under the concitions 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 iritis, 0, 1, and 0.3 for chemosis and 0.3, 2, and 1 for conjunctivae redness for animal 1, 2, and 3 respectively. The eye findings observed were reversible in one animal within 48 hours; another animal was free of signs 72 hours after instillation and in the 3rd animal the eye findings were reversible within 15 days 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 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 (BASF 1994). The average score (24 to 72 hours) for erythema was calculated to be 0.7, 0, and 0 for the three animals, respectively. The score for edema was 0 for all animals. The erythema observed in one animal was reversible within 72 hours after removal of the patch. 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 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 iritis, 0, 1, and 0.3 for chemosis and 0.3, 2, and 1 for conjunctivae redness for animal 1, 2, and 3 respectively. The eye findings observed were reversible in one animal within 48 hours; another animal was free of signs 72 hours after instillation and in the 3rd animal the eye findings were reversible within 15 days 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 / 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 obtained in the skin irritation test (according to OECD guideline 404) and the eye irritation test (according to OECD guideline 405) showing very limited effects, 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.