Registration Dossier

Administrative data

Description of key information

No relevant skin or eye irritating effects were seen in in-vivo studies in rabbits according to OECD 404 and 405, respectively.

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:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Weight at study initiation: 2.3- 2.8 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3degrees C
- Humidity (%): 50± 20%
- Photoperiod (hrs dark / hrs light): 12 hours daily of light
Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
water
Controls:
no
Amount / concentration applied:
-500 mg test substance was applied with 0.45 mL deionized water
Duration of treatment / exposure:
4 h
Observation period:
30- 60 minutes, 24, 48 and 72 hours after removal of the patches
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 25 cm2
- Type of wrap if used: surgical plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): substance were carefully removed from the skin with warm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM:
- According to the score of DRAIZE
Irritation parameter:
erythema score
Basis:
animal: 1, 2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Max. score:
4
Remarks on result:
not determinable
Remarks:
discolouration of skin did not allow a precise erythema analysis
Irritation parameter:
edema score
Basis:
mean
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of corrosive effects
Other effects:
30-60 min up to 24 h after removing the plaster very slight to well shaped erythem and oedema were found in the animals. The skin surface was discoloured pale blue up to 48 h. 72 h after removing the plaster all signs of skin irritations were reversible.
Interpretation of results:
GHS criteria not met
Conclusions:
Slight erythema effects occurred in 2/3 animals but were fully reversible within 48 h. The substance is not classifiable according to CLP criteria.
Executive summary:

In a primary dermal irritation study, 3 New Zealand albino rabbits obtained from Charles River Deutschland GmbH weighing 2.3-2.8 kg were dermally exposed to Reactive Navy FC63805 in deionized water to an area of 25 cm2 on the dorsal region of the body with hair removed with an electric clipper. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 3 days. Irritation was scored according to DRAIZE.

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:
1998-02-10 to 1998-02-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
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 ANIMALS
- Source: Charles River Deutschland GmbH
- Weight at study initiation: 3.3- 3.7 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3degrees C
- Humidity (%): 50± 20%
- Photoperiod (hrs dark / hrs light): 12 hours daily of light
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24h
Observation period (in vivo):
Eyes were examined 1, 24, 48 and 72 hours after administration
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- 24 hours after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37 degrees C.

SCORING SYSTEM:
-Cornea: degree of opacity (0-4), affected area (0-4)
- Iris (0-2)
- Conjunctivae: redness (0-3), chemosis (0-4), discharge (0-3)
- Additional information: S =slight, M =moderate, E =extreme, X = finding present, N = previous finding reversible, ? = not assessable
Irritation parameter:
conjunctivae score
Basis:
animal: 1, 3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of corrosivity observed. All very slight signs of irritation disappeared within 72 h.
Other effects:
Additionally a slight swelling of the conjunctiv and a clear substance coloured outflow was observed. 3 days p.a. the symptoms were reversible.
Interpretation of results:
GHS criteria not met
Conclusions:
Reactive Navy FC63805 is classified as not irritating as a result from the eye irritation experiment in New Zealand albino rabbits according to CLP criteria.
Executive summary:

In a primary eye irritation study according to OECD 405, 100 mg of Reactive Navy FC63805 was instilled into the conjunctival sac of the left eye of 3 New Zealand albino rabbits obtained from Charles River Deutschland GmbH weighing 3.3-3.7 kg for 24 hours. Treated eyes were washed with isotonic saline at approx. 37 degrees C 24 hours after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place. Animals were then observed for 3 days. Irritation was scored by the method described previously.

In this study, Reactive Navy FC63805 is not considered an eye irritant.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a primary dermal irritation study, 3 New Zealand albino rabbits were dermally exposed to Reaktiv Marineblau FC 63805 in deionized water to an area of 25 cm² on the dorsal region of the body. Animals were then observed for 3 days. Irritation was scored according to DRAIZE. The mean score for erythema was 0.7 (max 3), and mean score for edema was 0 (max 0), therefore, Reaktiv Marineblau FC 63805 is slightly irritating to the skin.

In a primary eye irritation study, 100 mg of Reaktiv Marineblau FC 63805 was instilled into the conjunctival sac of the left eye of 3 New Zealand albino rabbits for 24 hours. Animals were then observed for 3 days. No effects on cornea or iris have been reported. The mean conjunctivae score was 0,44. The conjuctivae and chemosis maximum scores were 1 and 2, respectively. Scores for the iris and cornea were both 0. Therefore, results conclude Reaktiv Marineblau FC 63805 is not considered an eye irritant.

Justification for classification or non-classification

All signs of slight irritation were fully reversible in rabbit eyes and on rabbit skin. No positive indication of skin or eye irritation or any signs of corrosion were found. The substance is not classifiable according to CLP criteria.