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Description of key information

Basic Blue 159 methyl sulfate was not irritating to the skin, but caused irreversible effects on rabbit 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
Study period:
15 - 22 Nov 1988
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
Remarks:
HC:NZW
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 2.7 - 3.3 kg
- Housing: one animal/cage (type III)
- Diet (e.g. ad libitum): "ssniff K4", ad libitum
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/12h
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µl
Duration of treatment / exposure:
4h exposure
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Hansamed patch (hypoallergenic)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4h after exposure

OBSERVATION TIME POINTS
1h, 24h, 48h, 72h, 7d and 14d

SCORING SYSTEM:
- Method of calculation: Draize
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

irritation scores

animal nr    observation time
24h 48h 72h
I erythema 0 0 0
edema 0 0 0
II erythema 0 0 0
edema 0 0 0
III erythema 0 0 0
edema 0 0 0
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance did not cause any signs of irritation on rabbit skin. The substance is not classifiable according to CLP criteria.
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:
15 - 22 Nov 1988
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
Remarks:
HC:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 3.2 kg
- Housing: one animal/cage (type III)
- Diet (e.g. ad libitum): "ssniff K4", ad libitum
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/12h
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): bulk volume of 100µL (approx. 45 mg test substance) of the test substance applied, eye closed for 1 second
Duration of treatment / exposure:
24 h exposure
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 24h

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein, UV light
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritant / corrosive response data:
Fluorescein test positive (24, 48, 72 h).

The animals showed a strong pain reaction after instillation of the test item. The animals was euthanised after 72 h since the irreversible necrosis of the eye was too strong to continue the experiment in the interest of animal welfare.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The substance caused severe and irreversible corrosion effects. The substance is classified as Category 1.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Basic Blue 159 methyl sulfate (57.4% dye, 26% acetic acid) was tested for skin and eye irritating effects according to OECD test guidelines 404 and 405, respectively, in 3 albino rabbits each. The test item did not cause any skin irritating effects in the rabbits. However, severe and irreversible effects on rabbit eyes were seen in the eye irritation study.

Justification for classification or non-classification

Based on the results of the eye irritation study, the test item is classified as Category 1 (irreversible effects on the eye) based on GHS criteria.