Registration Dossier

Administrative data

Description of key information

Skin irritation: The test substance is not irritating to the skin.

Eye irritation: 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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
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:
- BASF-method, 20h exposure
- Occlusive type of coverage instead of semi-occlosive.
- Exposure period of 20 h instead of 4 hours.
- Observation period of 8 days instead of 14 days.
The named deviations from the OECD guideline 404 represents a tightening of the test conditions.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.24 and 3.04 kg
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Concentration: 50% solution
Duration of treatment / exposure:
20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: Back and ear of the rabbits
- % coverage: Back: 2.5 x 2.5 cm

OBSERVATION TIME POINTS: 24 hours and 8 days

SCORING SYSTEM:
- Method of calculation: Draize method
Irritation parameter:
erythema score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal: #1 and #2
Time point:
other: 20 hours
Remarks on result:
no indication of irritation
Remarks:
red substance residues
Irritation parameter:
edema score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal: #1 and #2
Time point:
other: 20 hours
Remarks on result:
no indication of irritation
Remarks:
red substance residues
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test material is not considered to cause corrosion or irritation to the skin.
Executive summary:

An skin irritation potential of the test substance was investigated in an in vivo study performed equivalent to OECD guideline 404. A 50% solution of the test substance in water was applied to the shaved skin of two Vienna White rabbits. The test was performed under occlusive conditions for an exposure period of 20 hours. The skin was scored for signs of irritation after 24 hours and 8 days. Under the conditions of this test no indication of skin irritation was observed.
The performed skin irritation test showed some deviations from the OECD guideline 404. For example the test item was tested under occlusive instead of semi-occlusive conditions. Further, an exposure period of 20 hours instead of 4 hours was applied. The named deviations from the OECD guideline 404 represents a tightening of the test conditions. Based on the results of this test, the test substance is considered not irritating to the skin.

Endpoint:
skin irritation: 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:
no adverse effect observed (not 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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye 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 405:
- End of the observation period after 8 days.
- No test substance removal.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 50 mg

Observation period (in vivo):
10 min, 1 h, 2 h, 24 h, 48 h, 96 h, 7d and 8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize method

Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
ca. 3 - ca. 4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal: #1 and #2
Time point:
48 h
Max. score:
4
Remarks on result:
other: This time point was not measured
Irritation parameter:
chemosis score
Basis:
animal: # 1 and #2
Time point:
72 h
Remarks on result:
other: This time point was not measured
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 8 d
Score:
ca. 3 - ca. 4
Max. score:
4
Remarks on result:
other: corrosion, ulceration
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
ca. 3 - ca. 4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 8 d
Score:
ca. 3 - ca. 4
Max. score:
4
Remarks on result:
other: corrosion, ulceration
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #2
Time point:
48 h
Max. score:
4
Remarks on result:
other: This time point was not measured
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #2
Time point:
72 h
Max. score:
4
Remarks on result:
other: This time point was not measured
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 8 d
Score:
4
Max. score:
4
Remarks on result:
other: corrosion, ulceration
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 8 days
Score:
4
Max. score:
4
Remarks on result:
other: corrosion, ulceration
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Max. score:
2
Remarks on result:
other: Not indicated in study report
Irritation parameter:
iris score
Basis:
animal: #1 and #2
Time point:
48 h
Max. score:
2
Remarks on result:
other: This time point was not measured
Irritation parameter:
iris score
Basis:
animal: #1 and #2
Time point:
72 h
Max. score:
2
Remarks on result:
other: This time point was not measured
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 8 d
Max. score:
2
Remarks on result:
other: Not indicated in study report
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Max. score:
2
Remarks on result:
other: Not indicated in study report
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 8 d
Max. score:
2
Remarks on result:
other: Not indicated in study report
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Max. score:
3
Remarks on result:
other: Not indicated in study report
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 8 d
Max. score:
3
Remarks on result:
other: Not indicated in study report
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Max. score:
3
Remarks on result:
other: Not indicated in study report
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 8 d
Max. score:
3
Remarks on result:
other: Not indicated in study report
Irritation parameter:
conjunctivae score
Basis:
animal: #1 and #2
Time point:
48 h
Max. score:
3
Remarks on result:
other: This time point was not measured
Irritation parameter:
conjunctivae score
Basis:
animal: #1 and #2
Time point:
72 h
Max. score:
3
Remarks on result:
other: This time point was not measured
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of this test, test substance causes serious eye damage.
Executive summary:

The eye irritation potential of the test substance was investigated in a study performed equivalent to OECD guideline 405. The unchanged test substance (50 mg) was applied to the eyes of two Vienna White rabbits. The test substance was not removed and the eyes were assessed for irritation after 10 min, 1 h, 2 h, 24 h, 48 h, 96 h, 7d and 8 days. The application of the undiluted substance caused irreversible damage to the eyes of the rabbits. After 8 days the eyes of both animals showed severe edema, as well as corrosion and ulceration were observed. Based on the study results, the test substance causes serious eye damage and has to be classified as eye damaging cat. 1, H318.

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: 
An skin irritation potential of the test substance was investigated in an in vivo study performed equivalent to OECD guideline 404. A 50% solution of the test substance in water was applied to the shaved skin of two Vienna White rabbits. The test was performed under occlusive conditions for an exposure period of 20 hours. The skin was scored for signs of irritation after 24 hours and 8 days. Under the conditions of this test no indication of skin irritation was observed.
The performed skin irritation test showed some deviations from the OECD guideline 404. For example the test item was tested under occlusive instead of semi-occlusive conditions. Further, an exposure period of 20 hours instead of 4 hours was applied. The named deviations from the OECD guideline 404 represents a tightening of the test conditions. Based on the results of this test, the test substance is not considered irritating to the skin.
Additionally, a disseminated dossier for the characteristically similar substance, 3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethylxanthylium chloride (CAS 3068-39-1) is available on the ECHA Homepage. Based on the QSAR Toolbox (version 4.2) similarity options, both substances share a very high degree of similarity with a similarity value of 92.54%. For CAS 3068-39-1 a primary skin irritation study according to OECD guideline 404 is available. Under the conditions of this study, the test material is not considered to cause corrosion or irritation to the skin. Thus, the skin irritation data of CAS 3068-39-1 supports the skin irritation result for the test substance (CAS 989-38-8).

Eye irritation: 

The eye irritation potential of the test substance was investigated in a study performed equivalent to OECD guideline 405. The unchanged test substance (50 mg) was applied to the eyes of two Vienna White rabbits. The test substance was not removed and the eyes were assessed for irritation after 10 min, 1 h, 2 h, 24 h, 48 h, 96 h, 7d and 8 days. The application of the undiluted substance caused irreversible damage to the eyes of the rabbits. After 8 days the eyes of both animals showed severe edema, as well as corrosion and ulceration were observed. Based on the study results, the test substance causes serious eye damage and has to be classified as eye damaging cat. 1, H318.
Additionally, a disseminated dossier for the characteristically similar substance, 3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethylxanthylium chloride (CAS 3068-39-1) is available on the ECHA Homepage. Based on the QSAR Toolbox (version 4.2) similarity options, both substances share a very high degree of similarity with a similarity value of 92.54%. According to study data with CAS 3068-39-1, the substance is also damaging to the eyes. Thus, the eye irritation data of CAS 3068-39-1 supports the eye irritation result for the test substance (CAS 989-38-8).

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 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.