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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
secondary source
Title:
OPINION ON Basic Red 76
Author:
Scientific Committee on Consumer Safety SCCS
Year:
2011
Bibliographic source:
Scientific Committee on Consumer Safety SCCS - adopted at its 10th plenary meeting of 22 March 2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
[7-hydroxy-8-[(2-methoxyphenyl)azo]-2-naphthyl]trimethylammonium chloride
EC Number:
269-941-4
EC Name:
[7-hydroxy-8-[(2-methoxyphenyl)azo]-2-naphthyl]trimethylammonium chloride
Cas Number:
68391-30-0
Molecular formula:
C20H22ClN3O2
IUPAC Name:
7-hydroxy-8-[(2-methoxyphenyl)diazenyl]-N,N,N-trimethylnaphthalen-2-aminium chloride
Constituent 2
Reference substance name:
Basic Red 76
IUPAC Name:
Basic Red 76
Details on test material:
Name of test material (as cited in study report): Basic Red 76Molecular formula (if other than submission substance): C20H22Cl1N3O2Molecular weight (if other than submission substance): 371.87Substance type: OrganicPhysical state: SolidAnalytical purity: 98.1%Impurities (identity and concentrations): water content = 5.1%(w/w); Monomethyl sulphate 11.8% (w/w); o-anisidine = 5ppm; Sulphated ash 0.4% (w/w); Chloride 1.6% (w/w); Sodium = 630 ppm; Calcium = 590 ppm; Saccharose = 25.8%(w/w)Lot/batch No.: 0050644101

In vivo test system

Test animals

Species:
mouse
Strain:
other: CBA/CaOlaHsd mice
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
other: ethanol:water (7:3 v/v)
Concentration:
2.5%, 5% and 10% in ethanol:water (7:3 v/v)
No. of animals per dose:
4 female mice per groups
Details on study design:
The control group was treated with the vehicle exclusivelyRANGE FINDING TESTS:A dilution of the test item in a mixture of ethanol:water (7:3 v/v) was made shortly before each dosing. Although acetone:olive oil (4:1 v/v) is recommended, ethanol:water (7:3 v/v) was selected as the vehicle due to pre-tests on the solubility of the test item. The highest non-irritating, “technically applicable” test item concentration was determined in a pre-test with 4 mice. Based on these test results 2.5%, 5% and 10% solutions were chosen for the main study.MAIN STUDYANIMAL ASSIGNMENT AND TREATMENT- No. of exposures: single application for 3 consecutive days- Exposure period: 3 days- Test groups: 2.5%, 5% and 10% solutions- Control group: vehicle control, positive control- Site: topical application to the dorsal surface of each ear lobe (left and right)- Frequency of applications: The application volume, 25 μl, was spread over the entire dorsal surface of each ear lobe once daily for 3 consecutive days.- Duration: No data- Concentrations: The application volume, 25 μl of 2.5%, 5% and 10% solutions.OTHER: Five days after the first topical application, all mice were administered with radio-labelled thymidine (³H-TdR) by intravenous injection via the tail vein.Approximately 5 hours after ³H-TdR application all mice were euthanized. The draining lymph nodes were excised and pooled for each experimental group. After preparation of the lymph nodes, desegregation and overnight precipitation of macromolecules, these precipitations were re-suspended and transferred to scintillation vials.The level of ³H-TdR incorporation was then measured by scintillation counting. The proliferative response of lymph node cells is expressed as the ratio of ³H-TdR incorporation into lymph node cells of treated animals relative to that recorded in control mice (stimulation index).
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
The positive control induced a distinct increase of the stimulation index and gave an EC3 of 11.7% w/v

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Calculation of the EC 3 value was not performed as none of the test concentrations produced a stimulation index of 3 or above.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: no data

Any other information on results incl. tables

Table 1: Stimulation Index of the test chemical.

 

Test chemical concentration

Stimulation Index

2.5% (w/v)

0.9

5% (w/v)

1.1

10% (w/v)

1.3

 

Calculation of the EC 3 value was not performed as none of the test concentration produced a stimulation index of 3 or above.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The sensitization potential of Basic Red 76 was determined by Mouse Local Lymphnode Assay.Stimulation Index of the test chemical was determined to be in range 0.9-1.3 Calculation of the EC 3 value was not performed as no test concentration produced a stimulation index of 3 or above.Based on the criteria of the test system, Basic Red 76 was a non-sensitizer when tested up to a concentration of 10% (w/v) in ethanol:water (7:3 v/v) in mice.
Executive summary:

The sensitization potential of Basic Red 76 was determined by Mouse Lymphnode Assay.

 

A dilution of the test item in a mixture of ethanol:water (7:3 v/v) was made shortly before each dosing. Although acetone:olive oil (4:1 v/v) is recommended, ethanol:water (7:3 v/v) was selected as the vehicle due to pre-tests on the solubility of the test item. The highest non-irritating, “technically applicable” test item concentration was determined in a pre-test with 4 mice. Based on these test results 2.5%, 5% and 10% solutions were chosen for the main study.

Each test group of mice was treated by topical application to the dorsal surface of each ear lobe (left and right) with the different test item concentrations. The application volume, 25 precipitations were re-suspended and transferred to scintillation vials.Five days after the first topical application, all mice were administered with radio-labelled thymidine (³H-TdR)by intravenous injection via the tail vein.

Approximately 5 hours after ³H-TdR application all mice were euthanized. The draining lymph nodes were excised and pooled for each experimental group. After preparation of the lymph nodes, desegregation and overnight precipitation of macromolecules, these precipitations were re-suspended and transferred to scintillation vials.

The level of ³H-TdR incorporation was then measured by scintillation counting. The proliferative response of lymph node cells is expressed as the ratio of ³H-TdR incorporation into lymph node cells of treated animals relative to that recorded in control mice (stimulation index).

 

The positive control induced a distinct increase of the stimulation index and gave an EC3 of 11.7% w/v

 

Stimulation Index of the test chemical was determined to be in range 0.9-1.3.

Calculation of the EC 3 value was not performed as none of the test concentrations produced a stimulation index of 3 or above.

 

Based on the criteria of the test system, Basic Red 76 was a non-sensitizer when tested up to a concentration of 10% (w/v) in ethanol : water (7:3 v/v) in mice.