Registration Dossier

Administrative data

Description of key information

Under experimental conditions Solvent black 46 has been found to be corrosive for the eyes (with irreversible damage) and is also expected to be a respiratory irritant.

Solvent Black 46 was not found to be an irritant for the skin 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 2012-03-06 to 2012-03-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste - F40260 Linxe)
- Age at study initiation: 13 to 14 weeks old
- Weight at study initiation: Between 2.73 and 3.10 kg
- Housing: individual box, installed in conventional air conditioned animal husbandry
- Diet (e.g. ad libitum): ad libitum (tap-water from public distribution system)
- Water (e.g. ad libitum): ad libitum (foodstuff SDS - C15)
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): From 30 to 70%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
distilled water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g, moistened with distilled water
Duration of treatment / exposure:
Exposure of 4 hours
Observation period:
Observation at 1 hour and then 24, 48 and 72 hours after removal of the patch.
Number of animals:
1 animal initially and 2 other animals.
Details on study design:
TEST SITE
- Area of exposure: area of 6 cm² per patch. On the opposite flank an untreated area served as the control.
- Type of wrap if used: strip of surgical adhesive tape under semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After removal of the patch, rinsing with distilled water and liquid paraffin.
- Time after start of exposure: At the end of the exposure period, i.e after 4 hours.


Irritation parameter:
erythema score
Basis:
animal: A1886
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: A1888
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: A1886
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: A1888
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: A1890
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal: A1890
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72h
Remarks:
24h = 1; 48h = 1
Other effects:
Yellow or slight blue coloration, not preventing local observations, noted on day 0 (at 1 hour post-dose) and remaining on day 3.

Individual skin reactions and average scores after 4 -hour exposure

OBSERVATIONS

INDIVIDUAL DATA

Total of individual data

Skin reaction

Observation time

Animal n°

Weight (kg)

Animal n°

Weight (kg)

Animal n°

Weight (kg)

A1886

Start: 2.73

A1888

Start: 2.79

A1890

Start: 2.93

End: 2.66

End: 2.80

End: 3.10


Erythema and eschar

1 hour (D0)

0

0

1

1

24 hours

0

0

1

1

48 hours

0

0

1

1

72 hours

0

0

0

0

Mean(24 to 72 hrs)

0

0

0.7

/

Oedema formation

1 hour (D0)

0

0

0

0

24 hours

0

0

0

0

48 hours

0

0

0

0

72 hours

0

0

0

0

Mean(24 to 72 hrs)

0

0

0

/

Other reactions

1 hour (D0)

0

24 hours

0

48 hours

0

72 hours

0

Mean(24 to 72 hrs)

0

0

0

/

²: Yellow coloration, not preventing local observations.

 ³: Slight blue coloration, not preventing local observations.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The result obtained, in these experimental conditions, enable to conclude that the test item Solvent Black 46 must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol or risk phrase is required.

In accordance with the regulation (EC) No. 1272/2008, the test item must not be classified. No signal word or hazard statment is required.
Executive summary:

The test item Solvent Black 46 was applied, as supplied, at the dose of 0.5g, under semi-occlusive dressing during 4 hours on an undamaged skin area of three New Zealand rabbits. The experimental protocol was established from the OECD guideline No. 404 dated April 24th, 2002 and the test method B.4 of the council regulation No. 440/2008 of 30 May 2008;

A very slight erythema was noted on the treated area of on animal, 1 hour after the patch removal and was totally reversible on day 3.

A sight yellow to blue coloration (not preventing erythema assessment ) was registered from the reading time 1 hour and remained on day 3 in all animals.

The results obtained, in these experimental conditions, enable to conclude that the test item Solvent Black 46 must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol or risk phrase is required.

In accordance with the regulation (EC) No. 1272/2008, the test item must not be classified. No signal word or hazard statement is required.

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 2012-06-25 to 2012-07-16
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:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste - F40260 Linxe)
- Age at study initiation: 13 weeks old
- Weight at study initiation: 2.90 kg (beginning of the test) - 3.08 kg (end of the test)
- Housing: individual box installed in conventional aire conditioned animal husbandry
- Diet (e.g. ad libitum): SDS-C15, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): 10 to 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12h light/12g dark

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
24 hr
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1 animal
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological rinse of the remaining test item
- Time after start of exposure: 1h

SCORING SYSTEM: Grading of Eye Reactions as displayed in the attached document titled "Solvent Black 46 - IO-OCDE-PH-12/0297 Scoring System".

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
chemosis score
Basis:
animal: A2132
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: A2132
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal: A2132
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal: A2132
Time point:
24/48/72 h
Remarks on result:
not determinable
Remarks:
the iris was not discernible at all reading times
Irritant / corrosive response data:
The test item leads to a non-reversible irritation
Other effects:
Blue coloration
White coloration of the upper membrane on day 7
Discharge with moistening of the eyelids and neighbouring hairs
Corneal neovascularization and corneal oedema
Iris not discernible at all reading times.

Total and Individual scores of ocular irritation

Observation time

CONJUNCTIVAE

IRIS

CORNEA

Chemosis

Discharge

Redness

Iris

Degree of opacity

Extend of opacity

 1 hour

2

2

1

*

0

0

24 hours

3

2

2

*

2

4

48 hours

3

2

2

*

2

4

72 hours

3

1

2

*

2

4

Day 7

3

1

2

*

2

4

Day 14••

3

1

2

*

2

4

Day 21••

3

2

0

*

2

4

 

*Iris not discernible

White coloration of the upper membrane

••Corneal neovascularization and corneal oedema

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the experimental conditions, the test item is classified as irritant category 1 (irreversible effects on the eye) according to the CLP regulation (EC) No. 1272/2008.
Executive summary:

The test item Solvent Black 46 was instilled as supplied, into the eye of one New Zealand rabbit at the dose of 0.1g. Remaining test item requiring a physiological rinse was noted one hour after the test item instillation. A blue coloration remained after rinsing. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No. 405 dated April 24th, 2002 and the test method B.5 of the council regulation No. 440/2008.

The ocular reactions observed during the study have been slight to important and partially reversible:

- at the conjunctivae level: a slight redness noted 1 hour after the test item instillation, turning into a moderate redness 24 hours after the test item instillation and totally reversible on day 21, associated with a moderate chemosis noted 1 hour after the test item instillation, turning into an important chemosis 24 hours after the test item instillation and remaining on day 21 (last day of the test, same intensity).

-at the corneal level: a moderate corneal opacity, noted 24 hours after the test item instillation and remaining on day 21 (same intensity).

The iris was not discernible whatever the reading time.

A white coloration of the upper membre was noted on day 7.

A corneal neovascularization and a corneal oedema were noted on day 14 and remained on day 21.

In conclusion, taking into account the irreversibility of lesions observed, the results obtained, under these experimental conditions, enable to conclude that the item Solvent Black 46 must be classified R41 "Risk of serious damage to eyes", according to the criteria for the classification, packaging and labelling of dangerous substances in complicance with E.E.C Directives 67/548, 2001/59 and 99/45. It must be characterised by the symbol "Xi" and the danger label "irritant".

In accordance with the Regulation (EC) No. 1272/2008, the test item must be classified in category 1 "irreversible effects on the eye". The signal word "Danger" and hazard statement H318 "Causes serious eye damage" are required.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation properties:

An Episkin test method was run on Solvent Black 46 but considered as incompatible with the test material. Therefore, an in vivo testing was performed to assess the endpoint. The test was negative.

For the eyes irritating properties:

In vitro testing performed on other solvent dyes were inconclusives. The accuracy of in vitro assays and their applicability domains for this category of substance cannot be assessed.

In order to assess this endpoint, an in vivo assay was performed on one rabbit only since the Solvent Black 46 was suspected to be at least irritating for the eyes.

The in vivo test shows that Solvent Black 46 was damaging irreversibily the eye.

Justification for selection of skin irritation / corrosion endpoint:

Two studies are available, one in vitro and one in vivo. As the in vitro was not adapted for the test item Solvent Black 46, an in vivo study was performed to assess the skin irritation endpoint.

Justification for selection of eye irritation endpoint:

Only one study available

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin and Eye irritation:

Based on in vivo testings, the Solvent Black 46 meets the criteria for classification Eye damage category 1 but not for skin irritation.

Irritation of the respiratory tract :

The substance Solvent Black 46 is a powder exhibiting a fine granulometry.

In the key study, the particles size distribution has been determined by laser diffraction. 90% of the particles size stands below 227 µm; 50% below 71.71 µm and 10% below 11.8 µm. In the supporting study, the size of 83.6 % of the total sample is less than 125 µm. Thus the MMAD is most probably below 100 µm.

It is then expected that this powder will be present all along the respiratory tract, however, only a small fraction (~10%) will penetrate deeply in the lungs.

Following an in vivo assay, it has been classified as eye damage category 1 according to the CLP regulation. The effect did not seem to be caused by a mechanical irritation. As a result solvent black 46 is foreseen to be a possible irritant for the mucous membrane lining the respiratory tract.Therefore it has been classified accordingly: STOT cat 3 - inhalation; H 335.