Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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-[(1E)-2-(4-methyl-2-sulfonatophenyl)diazen-1-yl]naphthalene-2-carboxylate
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