Registration Dossier

Administrative data

Description of key information

The test substance is not irritating to skin or eyes, as tested in a skin irritation study  in accordance with OECD 404 and an eye irritation study in accordance with OECD 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:
1998-03-24 to 1998-03-27
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
- Source: Charles River Deutschland GmbH
- Weight at study initiation: 3.6- 3.9 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: 2.5 x 2.5 cm
- 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:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
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:
Reversibility of any observed effect: Changes fully reversible within 2 days
Other effects:
30-60 min up to 24 h after removing the plaster the treated skin of the animals showed very slight erythema. After removing the plaster all signs of skin irritations were reversible.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the result of this study Reactive Red FC73270 is not irritating to skin.
Executive summary:

In a primary dermal irritation study, 3 New Zealand albino rabbits obtained from Charles River Deutschland GmbH weighing 3.6 -3.9 kg were dermally exposed to Reactive Red FC73270 in deionized water to an area of 2.5 x 2.5 cm 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.

In this study, Reactive Red FC73270 is not irritating to the skin. A mean score of 0.1 for erythema does not warrant classification according to Regulation 1272/2008 (CLP)

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:
1998-03-31 to 1998-05-19
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 ANIMALS
- Source: Charles River Deutschland GmbH
- Weight at study initiation: 3.3- 3.9 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
At 24 and 72 hours as well as after 7 ,14 and 21 days, the eyes were also examined for corneal lesions under UV light after instillation of one drop of a 0.01 % fluorescein-sodium solution
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- 24 hours after administration the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C.

SCORING SYSTEM: according to Draize
-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
Remarks:
(redness)
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.11
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0.11
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Other effects:
The nictitating membranes and iris were violet discoloured.
Interpretation of results:
GHS criteria not met
Conclusions:
Reactive Red FC73270 is not irritating to eye.
Executive summary:

In a primary eye irritation study according to OECD 405, 100 mg of Reactive Red FC73270 was instilled into the conjunctival sac of the left eye of 3 New Zealand albino rabbits obtained from Charles River Deutschland GmbH weighing 3.3-3.9 kg for 24 hours. Treated eyes were washed with isotonic saline at approx. 37°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 21 days. Irritation was scored according to Draize.

In this study, Reactive Red FC73270 is not irritating to eye according to the CLP regulation.

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 obtained from Charles River Deutschland GmbH weighing 3.6 -3.9 kg were dermally exposed to Reactive Red FC73270 in deionized water to an area of 2.5 x 2.5 cm 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.

In this study, Reactive Red FC73270 is not irritating to the skin. A mean score of 0.1 for erythema does not warrant classification according to Regulation 1272/2008 (CLP)

In a primary eye irritation study according to OECD 405, 100 mg of Reactive Red FC73270 was instilled into the conjunctival sac of the left eye of 3 New Zealand albino rabbits obtained from Charles River Deutschland GmbH weighing 3.3-3.9 kg for 24 hours. Treated eyes were washed with isotonic saline at approx. 37°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 21 days. Irritation was scored according to Draize.

In this study, Reactive Red FC73270 is not irritating to eye according to the CLP regulation.

Justification for classification or non-classification

A 24/48/72-h mean score of 0.1 for skin erythema (fully reversible within 48 h) and 1.11 for eye conjunctivae (fully reversible within 7 d) do not result in a classification according to Regulation 1272/2008 (CLP).

The substance was classified for serious eye damage under Directive 67/548/EEC due to irreversible staining of the nictitating membranes and the iris. However, this classification is no longer necessary under Regulation 1272/2008, as the vision is not impeded by this staining.