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Diss Factsheets

Administrative data

Description of key information

The test substance was tested fo its potential to cause skin and eye irritation in studies according to OECD Guideline 404 and 405. As a result, the substance is not considered to be classified for skin or eye irritation.

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:
23rd June 1992 to 3rd July 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1984
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Chemisch pharmazeutische Fabrik Dr. K. Thomae, Biberach, Germany
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.6-3.2 kg
- Housing: singly
- Diet: ad libitum Altromin 2123 maintenance diet - rabbits
- Water: deionized, chlorinated water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/- 3
- Humidity (%): 55+/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: polyethylene glycol (0.5 mL)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- 0.5 g

VEHICLE
- 0.5 mL

Duration of treatment / exposure:
4 h
Observation period:
Examinations took place after 30-60 min, 24, 48 and 72 hours after removal of the patches.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm in the dorsal region of the body
- % coverage:
- Type of wrap if used: surgical plaster and semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with warm tap water
- Time after start of exposure: directly after removal of the patch
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
72 h after removal of the test patches all irritations were reversible.
Other effects:
From 30 min up to 48 h after removal of the patches the skin surface of the animals was large yellowish discoloured by the test compound.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the study according to OECD Guideline 404 the test item is not irritating to skin.
Executive summary:

The test substance was tested for its potential to cause skin irritation in a study according to OECD Guideline 404. Three female New Zealand White rabbits were treated with a single dermal application under semiocclusive dressing for 4 hours. After removal of the patches, the test sites were scored according to Draize. No edema formation was noted, and only slight and reversibble erythema formation in two animals was recorded (24/48/72 hours mean values 0.3 and 0.7, respectively). Therefore, the test substance was shown to not cause skin irritation.

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
Study period:
July 7-21, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1984
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Chemisch pharmazeutische Fabrik Dr. K. Thomae, Biberach, Germany
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.9-3 kg
- Housing: singly
- Diet: ad libitum Altromin 2123 maintenance diet – rabbits and hay
- Water: deionized, chlorinated water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/- 3
- Humidity (%): 55+/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- 100 mg
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
The eyes were examined 1, 24, 48 and 72 houry after application of the test substance and after 7 days.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
From one hour up to 24 h the conjunctivae of the animals showed slight to obvious swellings with partial eversion of lids. Up to 72 h p.a. evident hyperaemie to diffuse deeper crimson coloured reddenings were noted. After 7 days the irritations were reversible.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the study according to OECD Guideline 405 the test item is not irritating to the eyes.
Executive summary:

The test substance was tested for its potential to cause eye irritation in a study according to OECD Guideline 405. Three  New Zealand White rabbits were treated with a single application of 100 mg test item in one eye. Signs of irritation were scored according to Draize. The 24/48/72 hours mean scores for animal No. 1/2/3 are the following: cornea scores: 0/0/0; iris scores: 0/0/0; conjunctiva scores: 1.3/1/2; chemosis scores: 0.3/0.3/0.3. All findings were reversible within 7 days. Therefore, the test substance is not considered to be classified for eye irritation.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:


The test substance was tested for its potential to cause skin irritation in a study according to OECD Guideline 404. Three female New Zealand White rabbits were treated with a single dermal application under semiocclusive dressing for 4 hours. After removal of the patches, the test sites were scored according to Draize. No edema formation was noted, and only slight and reversibble erythema formation in two animals was recorded (24/48/72 hours mean values 0.3 and 0.7, respectively). Therefore, the test substance was shown to not cause skin irritation.


 


Eye irritation:


The test substance was tested for its potential to cause eye irritation in a study according to OECD Guideline 405. Three  New Zealand White rabbits were treated with a single application of 100 mg test item in one eye. Signs of irritation were scored according to Draize. The 24/48/72 hours mean scores for animal No. 1/2/3 are the following: cornea scores: 0/0/0; iris scores: 0/0/0; conjunctiva scores: 1.3/1/2; chemosis scores: 0.3/0.3/0.3. All findings were reversible within 7 days. Therefore, the test substance is not considered to be classified for eye irritation.

Justification for classification or non-classification

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. Based on available data on skin and eye irritation/corrosion, the test item is not considered to be classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the seventeenth time in Regulation (EU) 2021/849.