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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from safety assessment reports

Data source

Reference
Reference Type:
secondary source
Title:
OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 18- COLIPA n° C175
Author:
THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS (SCCNFP)
Year:
2004
Bibliographic source:
THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS (SCCNFP), last updated 23 April 2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Neutral Red Uptake assay (NRU) on human keratinocytes with the modification that human keratinocytes of the HaCaT cell line were used.
Principles of method if other than guideline:
The ocular irritation potential of Acid Red 18 was assessed by determining the Cytotoxicity in the neutral red uptake assay (NRU) on human keratinocytes with the modification that human keratinocytes of the HaCaT cell line were used.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4',6,8-trisulphonate
EC Number:
220-036-2
EC Name:
Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4',6,8-trisulphonate
Cas Number:
2611-82-7
Molecular formula:
C20H14N2O10S3.3Na
IUPAC Name:
1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-((4-sulfo-1-naphthalenyl)azo)-, trisodium salt
Test material form:
solid
Details on test material:
Name of the test chemical : 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-((4-sulfo-1-naphthalenyl)azo)-, trisodium salt
Common Name: Acid Red 18
Molecular Formula: C20H11N2Na3O10S3
Molecular Weight: 604.5 g/mol
Substance Type: Organic
Physical State: Solid
Specific details on test material used for the study:
Name of the test chemical : 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-((4-sulfo-1-naphthalenyl)azo)-, trisodium salt
Common Name: Acid Red 18
Molecular Formula: C20H11N2Na3O10S3
Molecular Weight: 604.5 g/mol
Substance Type: Organic
Physical State: Solid
Batch number : lot A003401

Test animals / tissue source

Species:
other: HaCaT human keratinocytes
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Test Tissue
- Type: HaCaT human keratinocytes

Test system

Vehicle:
water
Controls:
yes
Amount / concentration applied:
681 – 10000 μg/ml [1% in water]
Duration of treatment / exposure:
no data available
Observation period (in vivo):
no data available
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
Two independent NRU assays with identical doses were performed
Details on study design:
no data available

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: cytotoxicity
Run / experiment:
NRU 50
Value:
> 10 000
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
other: cell viability
Run / experiment:
NRU 50
Value:
61
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: NRU-50 value determined from the cytotoxicity curves was 61% in the first assay
Irritation parameter:
other: cell viability
Run / experiment:
NRU 50
Value:
70
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: NRU 50 was determined to be 70% in the second assay
Other effects / acceptance of results:
No NRU-50 value could be determined from the cytotoxicity curves as the viability was still 61% in the first assay and 70% in the second, so the NRU-50 was reported to be > 10000 μg/ml

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
No NRU(Neutral Red uptake)-50 value could be determined from the cytotoxicity curves as the viability was still 61% in the first assay and 70% in the second, so the NRU-50 was reported to be > 10000 μg/ml.
Hence, Acid red 18 can be considered not irritating to Human Keratinocytes in the neutral red uptake assay.
Executive summary:

The ocular irritation potential of Acid Red 18 was assessed by determining the Cytotoxicity in the neutral red uptake assay (NRU) on human keratinocytes with the modification that human keratinocytes of the HaCaT cell line were used.The treatment was performed in serum-free culture medium. Doses from 681 – 10000 μg/ml [1% in water] were applied together with appropriate controls.Two independent NRU assays with identical doses were performed.No NRU-50 value could be determined from the cytotoxicity curves as the viability was still 61% in the first assay and 70% in the second, so the NRU-50 was reported to be > 10000 μg/ml.

Hence, Acid red 18 can be considered not irritating to Human Keratinocytes in the neutral red uptake assay.