Registration Dossier

Administrative data

Description of key information

Several in vivo skin irritation/corrosion studies according or similar to OECD guideline 404 and in vivo eye irritation studies according or similar to OECD guideline 405 are available. The test items were not irritating to the skin and not irritating to the eyes.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Three animals were applied 500 µl of the test substance (RESOLIN Rotviolett FBL fl. 3. Umstellung) under semiocclusive conditions for 4 hours. After 4 hours the skin areas were washed with water. After 1, 24, 48, 72 hours and 7 days the skin areas were scored for erythema and edema according to Draize.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The animals were housed in wire cages typ III (high) at a room temperature of 22 ± 2° C and a relative humidity of ca. 50%. The dark/light cycle was 12 hours. The animals received a standard nutrition and water ad libitum.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
500 µl
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 animals
Details on study design:
One day before the application of the test substance, an area of 6 x 6 cm of the animals was clipped. Only animals with intact skin were used. 500 µl of the test substance was applied under semiocclusive conditions for 4 hours. Afterwards the skin areas were washed with water. After 1, 24, 48, 72 hours and 7 days the skin areas were scored for erythema and edema according to Draize.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
The test substance was not irritating to the skin.
Interpretation of results:
GHS criteria not met
Conclusions:
The erythema and edema score was 0 at 24, 48 and 72 hours.
Executive summary:

Three animals were applied 500 µl of the test substance (RESOLIN Rotviolett FBL fl. 3. Umstellung) under semiocclusive conditions for 4 hours. After 4 hours the skin areas were washed with water. After 1, 24, 48, 72 hours and 7 days the skin areas were scored for erythema and edema according to Draize. The erythema and edema score was 0 at 24, 48 and 72 hours.

RESOLIN Rotviolett FBL fl. was not irritating to the skin.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Three animals were applied 100 µl of the test substance (RESOLIN Rotviolett FBL fl. 3. Umstellung) into the conjunctival sac. After 24 hours the eyes were washed with physiological saline. After 1, 24, 48, 72 hours and 7 days the eyes were scored for cornea, iris, conjunctivae and chemosis according to Draize.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The animals were housed in wire cages typ III (high) at a room temperature of 22 ± 2° C and a relative humidity of ca. 50%. The dark/light cycle was 12 hours. The animals received a standard nutrition and water ad libitum.
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 µl
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 animals
Details on study design:
Three animals were applied 100 µl of the test substance (RESOLIN Rotviolett FBL fl. 3. Umstellung) into the conjunctival sac. After 24 hours the eyes were washed with physiological saline. After 1, 24, 48, 72 hours and 7 days the eyes were scored for cornea, iris, conjunctivae and chemosis according to Draize.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0 at any time point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
Cornea opacity, iris, conjunctivae and chemosis scores were 0 at any time point (24, 48 and 72 hours).
Other effects:
No data
Interpretation of results:
GHS criteria not met
Conclusions:
Cornea opacity, iris, conjunctivae and chemosis scores were 0 at any time point (24, 48 and 72 hours).
Executive summary:

Three animals were applied 100 µl of the test substance (RESOLIN Rotviolett FBL fl. 3. Umstellung) into the conjunctival sac. After 24 hours the eyes were washed with physiological saline. After 1, 24, 48, 72 hours and 7 days the eyes were scored according to Draize. Cornea opacity, iris, conjunctivae and chemosis scores were 0 at any time point (24, 48 and 72 hours).

RESOLIN Rotviolett FBL fl. 3. Umstellung was not irritating to the eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In all available studies for skin irritation/corrosion or eye irritation the test items were not irritating. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is therefore not justified.