Registration Dossier

Administrative data

Description of key information

Reactive Blue 72 was found to be not irritating to the skin and eyes 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
Study period:
From 24 February, 1987 to 27 February, 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted May 12, 1981, by the OECD council)
Deviations:
yes
Remarks:
Occlusive testing conditions represent elevated testing conditions compared to today's standard protocols. Therefore, results need to be interpret with care.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: Approx. 12 to 14 weeks
- Weight at study initiation: 2480 to 2780 g
- Housing: individually in metal cages
- Diet: Standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30-70 %
- Photoperiod: 12 h dark/12 h light

IN-LIFE DATES: From February 24, 1987 to February 27, 1987
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated contralateral flank of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE & APPLICATION
- An area of at least 6 cm² was shaved on both flanks of the animals approximately 24 h before treatment. A gauze patch (20 cm²) bearing 500 mg of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. Both gauze patches were moistened before application with distilled water. The patches were loosely covered with an aluminum foil (36 cm² ) and held in place for 4 h by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

OBSERVATION: The animals were checked daily for systemic symptoms and mortality. The body weight was recorded at start and on Day 3 of the test.

SCORING SYSTEM: The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema 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:
FAT 40045/C induced slight erythema reactions when applied to the clipped albino rabbit skin. The reactions were observed only one hour after removing the bandages.
Other effects:
There were no signs of body weight variability, toxicity or mortality in any animal during the study period.

Erythema  

Animal No. 72/F

136/M

CF/TF

137/M

CF/TF

138/M

CF/TF

After 1 hr.

0/1

0/1

0/1

After 24 hrs.

0/0

0/0

0/0

After 48 hrs.

0/0

0/0

0/0

After 72 hrs.

0/0

0/0

0/0

Mean (24 – 72 hrs.)

0/0

0/0

0/0

 

Oedema

 

Animal No. 72/F

136/M

CF/TF

137/M

CF/TF

138/M

CF/TF

After 1 hr.

0/0

0/0

0/0

After 24 hrs.

0/0

0/0

0/0

After 48 hrs.

0/0

0/0

0/0

After 72 hrs.

0/0

0/0

0/0

Mean (24 – 72 hrs.)

0/0

0/0

0/0

 

CF = control flank TF = test flank M = male F = female

 

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was considered to be not irritating to the skin.
Executive summary:

A study was performed to assess the skin irritation potential of FAT 40045/C (of 100 % purity) in New Zealand White rabbits according to OECD Guideline 404. 500 mg of test substance was applied to a shaved skin area of 6 cm² on one flank of each animal under a 20 cm² gauze pad. The pad was allowed to remain in contact with the skin for 4 h. Animals were scored for irritation reactions after 1, 24, 48 and 72 h. FAT 40045/C induced slight erythema reactions when applied to the clipped albino rabbit skin. The reactions were observed only one hour after removing the bandages. No signs of body weight variability, toxicity or mortality were observed in any animal. Based on these findings, the test substance was considered to be not irritating to 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
Study period:
From 17 March, 1987 to 24 March, 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: Approx. 12 to 14 weeks
- Weight at study initiation: 2390 to 2540 g
- Housing: The animals were housed individually in metal cages
- Diet: Standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C
- Humidity: 30-70 %
- Photoperiod: 12 h dark/12 h light

IN-LIFE DATES: From March 17, 1987 to March 24, 1987
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL (49 mg)
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
3 females
Details on study design:
Prior to test substance instillation, the animals were physically examined to ensure normal ocular surface integrity.

SCORING SYSTEM: OECD scoring system

TOOL USED TO ASSESS SCORE: Slit lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 72 hr
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
In all animals slight blue staining (test substance related) in the cornea was found which impeded 1 h observation of conjunctival redness.
Other effects:
There were no signs of body weight variability, toxicity or mortality in any animal during the study period.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was considered to be not irritating to the eye.
Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance (of 100 % purity) to the eyes of New Zealand White rabbits according to OECD Guideline 405. A single ocular dose of 0.1 mL (49 mg) of test substance was applied into the conjunctival sac of right eye of each animal. The eyelids were then gently held together for one sec before releasing. The untreated eye served as control. Without washing, eyes were scored for irritation reactions at 1, 24, 48 and 72 h and 7 d post-instillation. Instillation of the test substance into the eye elicited mild conjunctival redness and chemosis. However, the mean scores of 24, 48 and 72 h in all the animals were below the threshold of significance (<2) and had resolved within 72 h after instillation. Based on these findings, the test substance was considered to be not irritating to the eye.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:

Two in vivo studies, were carried out to evaluate skin irritation/corrosion and eye irritation potency of the test substance following OECD guidelines without GLP.

In the most reliable in vivo study, 500 mg of test substance was applied to a shaved skin area of 6 cm² on one flank of each animal under a 20 cm² gauze pad. The pad was allowed to remain in contact with the skin for 4 h. Animals were scored for irritation reactions after 1, 24, 48 and 72 hours. There was no evidence of any dermal reactions or corrosive effect on the skin. Based on these findings, the test substance was considered to be non-irritating to skin. Another study performed in 1974, also supported the conclusion that Reactive blue 72 (FAT 40045) is not irritating to the skin.

Eye:

An in vivo study (1987) was performed according to OECD Guideline 405. A single ocular dose of 0.1 mL (49 mg) of test substance was applied into the conjunctival sac of right eye of each animal. Without washing, eyes were scored for irritation reactions at 1, 24, 48 and 72 hours and on day 7 post-instillation. Instillation of the test substance into the eye elicited mild conjunctival redness and chemosis. However, the mean scores of 24, 48 and 72 h in all the animals were below the threshold of significance (<2) and had resolved within 72 h after instillation. Based on these findings, the test substance was considered to be non-irritant to the eye. Another study performed in 1974, also supported the conclusion that Reactive Blue 72 (FAT 40045) is not irritating to the eyes of rabbits.

Justification for classification or non-classification

Reactive Blue 72 was found to be not irritating to the skin and eyes of rabbits, hence it does not warrant classification as per the Regulation (EC) No. 1272/2008 (CLP).