Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The test substance is irritating to the skin.

The test substance causes serious eye damage.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

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:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Federal Register 38, No. 187, 27.09.1973
Version / remarks:
1973
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Refer to section 'Principles of method if other than guideline'
Principles of method if other than guideline:
Deviation from OECD guideline 404:
- Occlosive type of coverage instead of semi-occlosive.
- Exposure period of 24 h instead of 4 hours.
- Examination of signs of irritation after 24 h, 48 h, 72 h and 96 h instead of examination after 1 h, 24 h, 48 h and 72 h after patch removal.
- Test substance application on the intact and scarified skin. According to guideline, the substance is only given to the intact skin.
The named deviations from the OECD guideline 404 represents a tightening of the test conditions.
GLP compliance:
no
Species:
rabbit
Strain:
Himalayan
Remarks:
SPF-Albino-Himalayan rabbits
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: Singly caged
- Diet: ERKA 8300 (Robert Koch oHG/Hamm), ad libitum
- Water: Tap water, ad libitum

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
other: sesame oil
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: undiluted, 10% and 1% solution of the test item

Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: An area of 3 x 3 cm was shaved and 2.5 x 2.5 gauze pads were applied to the skin areas.
- Type of wrap if used: The gauze pads were adhered to the prepared skin with an adhesive tape. The gauze pads were covered with an inpermeable, 6-8 cm wide PVC film and then wrapped with an elastic permanent bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS: 24 h, 48 h 72 h and 96 h

SCORING SYSTEM:
- Method of calculation: OECD Draize scheme
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: undiluted test item, intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: undiluted test item, intact and abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 10% test item concentration, intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 10% test item concentration, intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.9
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 10% test item concentration, abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 10% test item concentration, abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 1% test item concentration, intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 1% test item concentration, intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 1% test item concentration, abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 1% test item concentration, abraded skin

Table 1: Results of the individual animals (undiluted test item concentration)

Animal No.

Irritation parameter

Hours

24

48

72

96

94

Erythema score

Edema score

4

4

4

4

4

4

4

4

95

Erythema score

Edema score

4

4

4

4

4

4

4

4

96

Erythema score

Edema score

4

4

4

4

4

4

4

4

97

Erythema score

Edema score

4

4

4

4

4

4

4

4

98

Erythema score

Edema score

4

4

4

4

4

4

4

4

99

Erythema score

Edema score

4

4

4

4

4

4

4

4

 

Table 2: Results of the individual animals (10% test item concentration)

Animal No.

Irritation parameter

Hours

24

48

72

394

Erythema score

Edema score

2

2

0

0

0

0

393

Erythema score

Edema score

2

2

0

0

0

0

392

Erythema score

Edema score

1

0

1

0

0

0

391

Erythema score

Edema score

1

1

1

0

0

0

390

Erythema score

Edema score

1

1

1

0

0

0

389

Erythema score

Edema score

1

1

1

0

0

0

 

Table 3: Results of the individual animals (1% test item concentration) 

Animal No.

Irritation parameter

Hours

24

48

72

394

Erythema score

Edema score

0

0

0

0

0

0

393

Erythema score

Edema score

1

0

0

0

0

0

392

Erythema score

Edema score

0

0

0

0

0

0

391

Erythema score

Edema score

0

0

0

0

0

0

390

Erythema score

Edema score

0

0

0

0

0

0

389

Erythema score

Edema score

0

0

0

0

0

0

 

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
Based on the results of this skin irritation test, the test substance is considered to be irritating to the skin.
Executive summary:

The skin irritation potential of the test substance was investigated in a study according to Federal Register 38, No. 187, 1973 and which is equivalent to OECD guideline 404. The undiluted test substance as well as a 10% and 1% test substance solution was applied to the intakt and scarified skin of six rabbits. The test was performed under occlusive conditions for an exposure period of 24 hours. The skin was scored for signs of irritation after 24 h, 48 h, 72 h and 96 h.

The undiluted test substance induced severe erythema and severe edema after 24 hours of treatment in all rabbits on the intact and scarified flank skin (mean erythema score 24/48/72h = 4; mean edema core 24/48/72h = 4). The results were not reversible within 96 hours.

The observed very mild to mild erythema and edema in the 10% test item solution were reversible within 72 hours. The very mild edema and erythema in the 1% test item solution were reversible within 48 hours.

Based on the results of this skin irritation test, the test substance is considered to be irritating to the skin.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
See section 'Principles of method other than guideline'
Principles of method if other than guideline:
According to OECD guideline 404 the animals should be observed up to 14 days after removal of the patches to determine the reversibility of effects. In this study oberservation of the skin areas was perfomed until the end of the test (5 days).
GLP compliance:
no
Specific details on test material used for the study:
- slightly thick, water-clear liquid
Species:
rabbit
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Housing: Singly caged
- Diet: ALTROMIN K (Altromin GmbH)
- Water: Tap water
Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
other: Sesame oil
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied. 0.5 mL
- Concentration: undiluted test substance and a 10%, 5% and 1% test substance solution.

Duration of treatment / exposure:
Application 5 times in 5 days
Observation period:
5 days
Number of animals:
not indicated.
Remarks on result:
positive indication of irritation

Application of the undiluted product resulted in redness and slight swelling of the flank skin in all rabbits after the first treatment. At the end of the experiment (after the fifth treatment) the flank skin was severely red, heavily swollen, bloody and necrotic.
The 10% and 5% solution caused marked reddening of the flank skin in all rabbits after the first and second treatment, respectively. The 1% concentration was tolerated by all rabbits without reaction.

Conclusions:
Examination of the skin tolerance resulted in very serious damage when the undiluted test substance was administered. The 10% and 5% dilutions revealed marked reddening of the flank skin in all rabbits. The 1% solution showed no reaction.
Executive summary:

In a skin irritation study in rabbits 0.5 mL of the undiluted test substance and a 10%, 5% and 1% test substance solution were applied five times in five days to the shaved skin of the rabbits. Examination of the skin tolerance resulted in very serious damage when the undiluted test substance was administered. The 10% and 5% dilutions revealed marked reddening of the flank skin in all rabbits. The 1% solution showed no reaction.

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: FDA Guideline (Federal Register, Vol. 38, No. 187, 1973
Version / remarks:
1973
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
See section 'Principles of method other than guideline'
Principles of method if other than guideline:
Deviation from OECD guideline 405:
- End of the observation period after 72 hours despite persisting irritation effects.
GLP compliance:
no
Specific details on test material used for the study:
The product was a clear oily liquid
Species:
rabbit
Strain:
Himalayan
Remarks:
SPF-Albino-Himalayan rabbits
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: Singly caged
- Diet: ERKA 8300 (Robert Koch oHG/Hamm), ad libitum.
- Water: Tap water, ad libitum
Vehicle:
other: sesame oil
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: undiluted and as a 10%, 1% solution.

Duration of treatment / exposure:
Single application (24 h).
Observation period (in vivo):
Undiluted test item: 1 h, 7 h, 24 h, 48 h and 72 h
10% test item solution: 1 h, 7 h, 24 h and 72 h
1% test item solution: 1 h, 7 h and 24 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Yes, all eyes were rinsed with physiological NaCl-solution.
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scheme

OTHER INFORMATION:
The appraisal was carried out with a magnifying glass (binocular) or slit lamp. After the 24-hour observation, all further observations were made after instillation of one drop of fluorescein in the dilution 1: 10000 (= 0.01%) directly on the cornea. Cornea damage appeared yellow. They were most visible in the dimmed room under UV light. After collecting the 24-hour report, all eyes were rinsed with physiological NaCl solution.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
other: Due to strong signs of irritation, the animals were killed after 72 hours.
Remarks on result:
other: undiluted test item
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Due to strong signs of irritation, the animals were killed after 72 hours.
Remarks on result:
other: undiluted test item
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
other: Due to strong signs of irritation, the animals were killed after 72 hours.
Remarks on result:
other: undiluted test item
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
other: Due to strong signs of irritation, the animals were killed after 72 hours.
Remarks on result:
other: undiluted test item
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48 h
Score:
0
Max. score:
4
Remarks on result:
other: 10% test item solution
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48 h
Score:
0
Max. score:
2
Remarks on result:
other: 10% test item solution
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48 h
Score:
1
Max. score:
3
Reversibility:
other:
Remarks on result:
other: 10% test item solution
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
other:
Remarks on result:
other: 10% test item solution

Table 1: Results of the individual animals (undiluted test item concentration)

Rabbit No.

Irritation parameter

Hours

1

7

24

48

72

394

Cornea opacity score

1

1

1

1

1

Iris score

0

0

0

0

0

Conjunctivae score

2

3

3

3

3

Chemosis score

2

3

4

4

4

393

Cornea opacity score

1

1

1

1

1

Iris score

0

0

0

0

0

Conjunctivae score

2

3

3

3

3

Chemosis score

2

3

4

4

4

392

Cornea opacity score

1

1

1

1

1

Iris score

0

0

0

0

0

Conjunctivae score

2

3

3

3

3

Chemosis score

2

3

4

4

4

391

Cornea opacity score

2

2

2

2

2

Iris score

0

0

0

0

0

Conjunctivae score

2

3

3

3

3

Chemosis score

2

4

4

4

4

390

Cornea opacity score

2

2

2

2

2

Iris score

0

0

0

0

0

Conjunctivae score

2

3

3

3

3

Chemosis score

2

4

4

4

4

389

Cornea opacity score

1

1

1

1

1

Iris score

0

0

0

0

0

Conjunctivae score

2

3

3

3

3

Chemosis score

2

4

4

4

4

Table 2: Results of the individual animals (10% test item concentration)

Rabbit No.

Irritation parameter

Hours

1

7

24

48

301

Cornea opacity score

0

0

0

0

Iris score

0

0

0

0

Conjunctivae score

1

1

1

1

Chemosis score

2

2

2

2

302

Cornea opacity score

0

0

0

0

Iris score

0

0

0

0

Conjunctivae score

1

1

1

1

Chemosis score

2

2

2

2

303

Cornea opacity score

0

0

0

0

Iris score

0

0

0

0

Conjunctivae score

1

1

1

1

Chemosis score

2

2

2

2

304

Cornea opacity score

0

0

0

0

Iris score

0

0

0

0

Conjunctivae score

1

1

1

1

Chemosis score

2

2

2

2

305

Cornea opacity score

0

0

0

0

Iris score

0

0

0

0

Conjunctivae score

1

1

1

1

Chemosis score

2

2

2

2

306

Cornea opacity score

0

0

0

0

Iris score

0

0

0

0

Conjunctivae score

1

1

1

1

Chemosis score

2

2

2

2

Table 3: Results of the individual animals (1% test item concentration)

Rabbit No.

Irritation parameter

Hours

1

7

24

301

Cornea opacity score

0

0

0

Iris score

0

0

0

Conjunctivae score

0

0

0

Chemosis score

0

0

0

302

Cornea opacity score

0

0

0

Iris score

0

0

0

Conjunctivae score

0

0

0

Chemosis score

0

0

0

303

Cornea opacity score

0

0

0

Iris score

0

0

0

Conjunctivae score

0

0

0

Chemosis score

0

0

0

304

Cornea opacity score

0

0

0

Iris score

0

0

0

Conjunctivae score

0

0

0

Chemosis score

0

0

0

305

Cornea opacity score

0

0

0

Iris score

0

0

0

Conjunctivae score

0

0

0

Chemosis score

0

0

0

306

Cornea opacity score

0

0

0

Iris score

0

0

0

Conjunctivae score

0

0

0

Chemosis score

0

0

0

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Application of the undiluted test item resulted in strong irritation to the eyes of all rabbits. Because of these serious injuries, the animals were prematurely withdrawn after 72 hours. The 10% dilution gave a slight reddening and increased swelling of the conjunctiva. The 1% dilution was tolerated without irritation. Based on the results of this eye irritation study, the test item is considered to be irritating to the eyes.
Executive summary:

The eye irritation potential of the test substance was investigated in a study according to FDA guideline (Federal Register, Vol. 38, No. 187, 1973) and which is equivalent to OECD guideline 405. The undiluted test substance as well as a 10% and 1% solution of the test substance in sesame oil was instilled into one eye of six albino Himalayan rabbits. The other untreated eye served as control. The eyes were washed with physiologic NaCl solution after 24 h. The eyes treated with the undiluted test item were assessed for irritation after 1 h, 7 h, 24 h, 48 h and 72 h. The eyes treated with 10% test item solution were observed for 48 h and the eyes treated with 1% test item solution were assessed for 24 hours.

The application of the undiluted substance resulted in strong irritation to the eyes of all rabbits. Due to strong signs of irritation, the animals were killed after 72 hours. The 10% dilution revealed a slight redness and a strong swelling of the conjunctiva. The 1% dilution was tolerated without irritation.

According to OECD guideline, the rabbits' eyes are normally assessed for a 21 days observation period. Therefore, the reversibility of the effects cannot be assessed. Based on the results of this eye irritation study, the test item is considered to be irritating to the eyes. As a worst case consideration, it must be assumed that the effects are not reversible and the substance has to be classified as skin irritating, cat. 1 (H 318).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Specific details on test material used for the study:
- slightly thick, water-clear liquid
Species:
rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: Singly caged
- Diet: ALTROMIN K (Altromin GmbH):
- Water: Tap water
Vehicle:
other: Sesame oil
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: undiluted test substance and 10%, 5%, 1% and 0.1% test substance solution.

Duration of treatment / exposure:
Single application
Observation period (in vivo):
144 h
Number of animals or in vitro replicates:
5
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Not specified.
Remarks on result:
positive indication of irritation

The undiluted or 10% diluted test substance resulted in very severe damage in all rabbits in the form of a deep red coloration and a very strong milky, ballooning swelling of the conjunctiva. In addition, a strong opacity of the cornea was visible.
80 hours after the application, the animals were prematurely killed because of these serious injuries. The 5% solution showed in all animals a slight reddening as well as a stronger, cloudy swelling of the conjunctiva. The cornea showed a slight opacity. These findings were reversible 144 hours after the application except for a very slight reddening of the conjunctiva. The 1% dilution gave a very slight reddening of the conjunctiva for about 7 to 24 hours. The 0.1% concentration was tolerated by all rabbits without reaction.

Conclusions:
Application of the undiluted test item and the 10% test item solution resulted in very severe damage of the eyes of all rabbits. The 5% concentration still causes significant damage to the eye. The application of the 1% concentration resulted in a very slight reddening of the conjunctiva. The 0.1% dilution was tolerated without reaction.
Based on these results, the test substance is considered to be irritating to the eyes.
Executive summary:

In an eye irritation study in rabbits 0.1 mL of the undilutest test substance and a 10% and 5%, 1% and 0.1% test substance solution were instilled into one eye of the rabbits. The eyes were assessed for irritation after 1, 3, 7, 24, 48, 72, 80 and 144 hours. Application of the undiluted test item and the 10% test item solution resulted in very severe damage of the eyes of all rabbits. The 5% concentration still causes significant damage to the eye. The application of the 1% concentration resulted in a very slight reddening of the conjunctiva. The 0.1% dilution was tolerated without reaction.

Based on these results, the test substance is considered to be irritating to the eyes.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:
The skin irritation potential of the test substance was investigated in a study according to Federal Register 38, No. 187, 1973 and which is equivalent to OECD guideline 404 (Hoechst AG, 1975). The undiluted test substance as well as a 10% and 1% test substance solution was applied to the intact and scarified skin of six rabbits. The test was performed under occlusive conditions for an exposure period of 24 hours. The skin was scored for signs of irritation after 24 h, 48 h, 72 h and 96 h.
The undiluted test substance induced severe erythema and severe edema after 24 hours of treatment in all rabbits on the intact and scarified flank skin (mean erythema score 24/48/72h = 4; mean edema core 24/48/72h = 4). The results were not reversible within 96 hourse. The observed very mild to mild erythema and edema in the 10% test item solution were reversible within 72 hours. The very mild edema and erythema in the 1% test item solution were reversible within 48 hours. The performed skin irritation test showed some deviations from the OECD guideline 404. For example the test substance was tested not only on the intact skin but also on the scarified skin under occlusive instead of semi-occlusive conditions. An exposure period of 24 hours instead of 4 hours was applied. The named deviations from the OECD guideline 404 represents a tightening of the test conditions. Thus, data observed under these test conditions leads to a conservative classification and labelling. Based on the results of this skin irritation test, the test substance is considered to be irritating to the skin and has to be classified as Skin Irrit. 2 (H315).

This result is supported by another skin irritation study in rabbits with only limited documentation (Hoechst AG, 1969). In this test, 0.5 mL of the undiluted test substance and a 10%, 5% and 1% test substance solution were applied five times in five days to the shaved skin of the rabbits. Examination of the skin tolerance resulted in very serious damage when the undiluted test substance was administered. The 10% and 5% dilutions revealed marked reddening of the flank skin in all rabbits. The 1% solution showed no reaction.

Eye irritation

The eye irritation potential of the test substance was investigated in a study according to FDA guideline (Federal Register, Vol. 38, No. 187, 1973) and which is equivalent to OECD guideline 405 (Hoechst AG, 1975). The undiluted test substance as well as a 10% and 1% solution of the test substance in sesame oil was instilled into one eye of six albino Himalayan rabbits. The other untreated eye served as control. The eyes were washed with physiologic NaCl solution after 24 h. The eyes treated with the undiluted test item were assessed for irritation after 1 h, 7 h, 24 h, 48 h and 72 h. The eyes treated with 10% test item solution were observed for 48 h and the eyes treated with 1% test item solution were assessed for 24 hours.

The application of the undiluted substance resulted in strong irritation to the eyes of all rabbits. Due to strong signs of irritation, the animals were killed after 72 hours. The 10% dilution revealed a slight redness and a strong swelling of the conjunctiva. The 1% dilution was tolerated without irritation.

According to OECD guideline, the rabbits' eyes are normally assessed for a 21 days observation period. Therefore, the reversibility of the effects cannot be assessed. Based on the results of this eye irritation study, the test item is considered to be irritating to the eyes. As a worst case consideration, it must be assumed that the effects are not reversible and the substance has to be classified as skin irritating, cat. 1 (H 318).

This result is supported by another eye irritation study in rabbits with only limited documentation (Hoechst AG, 1969). In this test, 0.1 mL of the undiluted test substance and a 10% and 5%, 1% and 0.1% test substance solution were instilled into one eye of the rabbits. The eyes were assessed for irritation after 1, 3, 7, 24, 48, 72, 80 and 144 hours. Application of the undiluted test item and the 10% test item solution resulted in very severe damage of the eyes of all rabbits. The 5% concentration still caused significant damage to the eye. The application of the 1% concentration resulted in a very slight reddening of the conjunctiva. The 0.1% dilution was tolerated without reaction.

Based on these results, the test substance is considered to be damaging to the eyes.

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 classified as Skin Irrit. 2, H315 (Causes skin irritation) and as eye damaging cat. 1, H318 (Causes serious eye damage) according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.