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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
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 or test system 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
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.