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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

Skin irritation: The test substance was determined to be not irritating to the skin.
Eye irritation: The test substance was determined to be irritating 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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline compliant but not GLP compliant study but nevertheless well documented and scientifically acceptable.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
May 1981
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, Germany
- Weight at study initiation: males 2.99 kg, female 2.34 kg
- Housing: One animal per cage (type: stainless steel with wire mesh walk floors, floor area 40 x 51 cm); they were identified via ear tattoo.
- Diet: standardized animal laboratory diet (about 130 g/animal/day)
- Water: tap water (about 250 mL/animal/day)
- Acclimation period: at least 8 days before study start

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%.
- Air changes: fully air-conditioned rooms
- Photoperiod: 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 covered with 0.5 g of the test substance and has been moistened with aqua dest.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
Clipping of the fur: at least 15 hours before study start
Application area: 2.5 x 2.5 cm
Application site: upper third of the back or flanks
Removal of the test substance: at the end of the exposure period with Lutrol and Lutrol/water (1:1)
Readings: 30 - 60 minutes after removal of the test patches and 24 h, 48 h and 72 h after beginning of application
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
female
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
female
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Interpretation of results:
not irritating
Remarks:
Migrated information
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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline compliant but not GLP compliant study but nevertheless well documented and scientifically acceptable.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
12 May 1981
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/ Main, Germany
- Weight at study initiation: males 3.21 kg, female 3.12 kg
- Housing: One animal per cage (type: stainless steel with wire mesh walk floors, floor area 40 x 51 cm); they were identified via ear tattoo.
- Diet: standardized animal laboratory diet (about 130 g/animal/day)
- Water: tap water (about 250 ml/animal/day)
- Acclimation period: at least 8 days before study start

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%
- Air changes: fully air-conditioned rooms
- 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 bulk volume (about 54 mg of the comminuted test substance)
Duration of treatment / exposure:
24 h
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
3
Details on study design:
Single application to the conjunctival sac of the right eyelid; the test substance was not washed out.
Readings: 1 h, 24 h, 48 h, 72 h, 8 d
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #1
Remarks:
female
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #2
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #3
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
female
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
female
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
female
Time point:
other: 24/48/72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Interpretation of results:
irritating
Remarks:
Migrated information

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Key study

 

Skin irritation

BASF SE, study no.: 18H0403/882179, 1972

 

In an OECD 404 guideline compliant but not GLP compliant skin irritation study with rabbits the test substance was applied on the upper third of the back or flanks. 3 animals were used.The animals were observed over a period time of 72 hours. The erythema score and edema score for each animal was recorded at 24, 48 and 72 hours. The mean score for each animal was reported to be 0.

Based on this result the test substance was determined to be not irritating to the skin.

 

 

 

Key study

 

Eye irritation

BASF SE, study no.: 11H0403/882180, 1988

 

In an OECD 405 guideline compliant but not GLP compliant eye irritation study the test substance was applied into the conjunctival sac of 3 rabbits. The animals were observed over a period of 8 days. Cornea opacity, iris, conjunctivae redness and chemosis scores were recorded at 24, 48 and 72 hours for each animal. The mean cornea opacity score was reported to be 1 at two animals the other animal was without any effects.

The mean conjunctivae score (redness) was for two animals 1 and for one animal 1.67.

The mean chemosis sore was for two animals 0.33 and for one animal no effects were seen. For the iris no effects were seen at all three animals.

Based on this result esp. cornea opacity the test substance is determined to be irritating to the eye.

 

 


Justification for selection of skin irritation / corrosion endpoint:
Guideline compliant but not GLP compliant study but nevertheless well documented and scientifically acceptable.

Justification for selection of eye irritation endpoint:
Guideline compliant but not GLP compliant study but nevertheless well documented and scientifically acceptable.

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Skin irritation

 

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 for skin irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.

 

 

Eye irritation

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 considered to be classified for eye irritant cat. 2, H319: Causes eye irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.