Registration Dossier

Administrative data

Description of key information

Skin irritation: The test item showed skin irritating effects. According to the CLP criteria a classification is not necessary. 
Eye irritation: The test item showed no eye irritating effects.

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
Study period:
1987-04-07 to 1987-04-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
other: Chbb-SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.0 - 2.1 kg
- Housing: Stainless steel cages, one animal per cage
- Diet: Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 °C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15 times
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 cm3
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours and 7, 8, 10 and 14 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6 cm2 skin area
- Type of wrap: cotton wool rolls and polyethylenfilm

REMOVAL OF TEST SUBSTANCE
- Washing: warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: According to OECD guideline 404
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 h
Score:
0.6
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 h
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
The test item showed skin irritating effects. According to CLP criteria a classification is not necessary.
Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987-04-13 to 1987-04-21
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, no GLP study, only basic data given
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
other: Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.0-2.1 kg
- Housing: Stainless steel cages, one animal per cage
- Diet: K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 1 °C
- Humidity (%): 60 % +/- 5 %
- Air changes: 15 times / hour
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 cm3

Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 hours and 4, 8 days after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: NaCl solution
- Time after start of exposure: 72 h

SCORING SYSTEM: Draize (Appraisals of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin 1, Texas 1959, page 51)

TOOL USED TO ASSESS SCORE: Na-Fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
The test item showed no eye irritating effects.
Interpretation of results:
GHS criteria not met
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 irritation

In a skin irritation test to rabbits a study was conducted with the test item according to OECD guideline 404. 3 rabbits were exposed for 4 hours to the test substance and observed for 72 hours and 14 days. The rabbits got an application of 0.5 cm3 occlusive. The mean erythema (24/48/72 h) of animal 1 and 2 was 2, of animal 3 1.3. The erythema effect was fully reversible within 14 days for animal 1, 10 days for animal 2 and 8 days for animal 3. The edema score (24/48/72 h) was 2.3 for animal 1 and 0.6 for animal 2 and 3. The edema effect was fully reversible within 14 days for animal 1 and for animal 3 within 8 days. The effect of animal 2 was not reversible. The test item showed irritating effects. According to the EU criteria a classification is not necessary because of negligible effects.

Eye irration

In an eye irritation test to white vienna rabbits a study was conducted with the test item according to OECD guideline 405. 3 rabbits were exposed to 0.1 cm3 unchanged test substance. The study was conducted with a single application to the conjunctival sac of the eyelid. The substance was washed out with a NaCL solution. The cornea and the iris score (24/48/72 h) showed a score of 0 for all animals. The conjunctivae score (24/48/72 h) was 0 for animal 1, 1 for animal 2 and and 1 for animal 3. The conjunctivae effect was fully reversible within 72 hours. The chemosis score (24/48/72 h) was 0 for animal 1, 0.33 for animal 2 and 3. The chemosis effect was fully reversibel within 48 hours. According to these results the test item showed no eye irritating effects. After 72 h of observation the test substance showed no irritating effects.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008:

The available experimental test data is 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.