Registration Dossier
Registration Dossier
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EC number: 281-589-3 | CAS number: 83969-12-4
Endpoint summary
Administrative data
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
- 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
- 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.
Reference
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 | |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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.
Reference
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.
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