Registration Dossier

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:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Clinical signs and body weights not reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Body weights and clinical signs were not reported.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
EC Number:
226-109-5
EC Name:
Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
Cas Number:
5281-04-9
Molecular formula:
C18H14N2O6S.Ca
IUPAC Name:
calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate
Test material form:
solid: nanoform
Details on test material:
- Name of test material (as cited in study report): Irgalite Rubine 6BL G861831
- Substance type: pigment
- Physical state: solid
- Purity test date: not indicated
- Lot/batch No.: G861831
- Expiration date of the lot/batch: open, manufactured in August 1986
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- described as red powder
- Analytical purity: 89% Pigment Red 57:1

Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Specific details on test material used for the study:
- Name of test material (as cited in study report): Irgalite Rubine 6BL G861831
- Substance type: pigment
- Physical state: solid
- Purity test date: not indicated
- Lot/batch No.: G861831
- Expiration date of the lot/batch: open, manufactured in August 1986
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- described as red powder
- Analytical purity: 89% Pigment Red 57:1]

Test animals

Species:
rabbit
Strain:
Californian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: (Hylyne Commercial Rabbits Ltd
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.71 kg (males) and 2.5 kg (females)
- Housing: single caging
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: One week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 50 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10h light daily


IN-LIFE DATES: From: July 21, 1987 To: July 24, 1987

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: 50% aqueous solutionof polyethylene glycol
Controls:
not required
Amount / concentration applied:
500 mg per animal
Duration of treatment / exposure:
4h
Observation period:
72 hours. As no findings were observed, the experiment was discontinued.
Number of animals:
2 males and 2 females
Details on study design:
Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. One test site close to the mid-line of the back was used on each rabbit.
2.5 g of the test compound was mixed with 4 ml of a 50% aqueous solutionof polyethylene glycol to give a suspension of 5 ml, 1.0 ml of which was applied to the test site on a 6 cm square gauze pad. This was covered with aluminium foil secured with "Transpore" surgical tape. The test site was then covered by a 6" wide 'Coban' self adhesive bandage in order to retain the test substance in close contact with the skin. After 4 hours the dressing was removed and the compound residue rinsed from the application site using lukewainn water. Sites were assessed for oedema and erythema 30 - 60 minutes after removal of the occlusive dressing. Further assessments were made at 24, 48 and 72 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met