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Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

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

Test system

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.


Results and discussion

In vivo

Resultsopen allclose all
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.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.