Registration Dossier

Administrative data

Description of key information

Bayscript Blaukomponente is not irritating to the skin of rabbits and not irritating to the mucous membranes of rabbits.

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)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.2-3.3 kg
- Housing: individually
- Diet ad libitum:
- Water ad libitum
- Acclimation period: at least 14 dqys

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20
- Humidity (%):50
- Air changes (per hr):10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite side of the back served as control
Amount / concentration applied:
500 µl
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
500 µl was applied to the shaved back of each of 3 rabbits and covered by semi-occlusive dressing. The exposure time was 4 hours. The opposite side of the back served as control. After removing of the dressing the treated area was carefully washed. The observation period lasted 14 days. The area were evaluated according to prescription of the guideline.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour - 14 days
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1h - 14 d
Score:
ca. 0
Max. score:
4
Irritant / corrosive response data:
the above results show that the test compound can be regarded as not irritating to the skin
Interpretation of results:
GHS criteria not met
Conclusions:
Skin irritation test was performed according to OECDTG 404 and GLP: 500 µl was applied to the shaved back of each of 3 rabbits and covered by semi-occlusive dressing. The exposure time was 4 hours.The opposite side of the back served as control. After removing of the dressing the treated area was carefully washed. The observation period lasted 14 days. The area were evaluated according to prescription of the guideline. No erythema(score0 of mac 4) or edema (score 0 of max 4) were observed in none of the 3 rabbits. Therefore, the test compound can be evaluated as not irritating to the skin. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Executive summary:

Skin irritation test was performed according to OECDTG 404 and GLP: 500 µl was applied to the shaved back of each of 3 rabbits and covered by semi-occlusive dressing. The exposure time was 4 hours.The opposite side of the back served as control. After removing of the dressing the treated area was carefully washed. The observation period lasted 14 days. The area were evaluated according to prescription of the guideline. No erythema(score0 of mac 4) or edema (score 0 of max 4) were observed in none of the 3 rabbits. Therefore, the test compound can be evaluated as not irritating to the skin. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.

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)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMAL
- Weight at study initiation: 3.2-3.3 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 /12
- Humidity: 50 %
Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite eye served as control
Amount / concentration applied:
100 µl
Duration of treatment / exposure:
1 second
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
100 µl of the test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second . The treated eye was washed out with physiological saline 24 hours after instillation of the test compound. The other eye remained untreated and served as control . Eye irritation was scored according to Draize during the observation period of 21 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour - 21 days
Score:
ca. 0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour - 21 days
Score:
ca. 0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour - 21 days
Score:
ca. 0
Max. score:
4
Irritant / corrosive response data:
No reactions in conjunctivae, cornea or iris of the eyes were observed in none of the 3 rabbits (score 0).
Other effects:
no
Interpretation of results:
GHS criteria not met
Conclusions:
Eye irritation test was performed according to OECD TG 405 and GLP: 100 µl of the test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second . The treated eye was washed out with physiological saline 24 hours after instillation of the test compound. The other eye remained untreated and served as control . Eye irritation was scored according to Draize during the observation period of 21 days. No reactions in conjunctivae, cornea or iris of the eyes were observed in none of the 3 rabbits.(Score 0 ). Therefore, the test compound is evaluated as not irritating to the eyes of rabbits. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Executive summary:

Eye irritation test was performed according to OECD TG 405 and GLP: 100 µl of the test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second . The treated eye was washed out with physiological saline 24 hours after instillation of the test compound. The other eye remained untreated and served as control . Eye irritation was scored according to Draize during the observation period of 21 days. No reactions in conjunctivae, cornea or iris of the eyes were observed in none of the 3 rabbits.(Score 0 ). Therefore, the test compound is evaluated as not irritating to the eyes of rabbits. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:

Skin irritation test was performed according to OECDTG 404 and GLP: 500 µl was applied to the shaved back of each of 3 rabbits and covered by semi-occlusive dressing. The exposure time was 4 hours. The opposite side of the back served as control. After removing of the dressing the treated area was carefully washed. The observation period lasted 14 days. The area was evaluated according to prescription of the guideline. No erythema (score 0 of max 4) or edema (score 0 of max 4) were observed in none of the 3 rabbits. Therefore, the test compound can be evaluated as not irritating to the skin.

Eye irritation test

Eye irritation test was performed according to OECD TG 405 and GLP: 100 µl of the test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second. The treated eye was washed out with physiological saline 24 hours after instillation of the test compound. The other eye remained untreated and served as control. Eye irritation was scored according to Draize during the observation period of 21 days. No reactions in conjunctivae, cornea or iris of the eyes were observed in none of the 3 rabbits (Score 0). Therefore, the test compound is evaluated as not irritating to the eyes of rabbits


Justification for selection of skin irritation / corrosion endpoint:
This guideline study under GLP conditions is the only one which is available and is evaluated with Klimisch Score 1

Justification for selection of eye irritation endpoint:
This guideline study under GLP conditions is the only one which is available and is evaluated with Klimisch Score 1

Justification for classification or non-classification

Bayscript Blaukomponente is not irritating to the skin of rabbits and not irritating to the mucous membranes of rabbits. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.