Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 305-403-8 | CAS number: 94534-99-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Direct Blue 199 ammonium salt was tested in the Local Lymph Node Assay (OECD 429, GLP) in form of a commercial aquaous formulation containing 19% of the colorant and 8% urea (BASF 2003).
It was dosed in the pure form (undiluted) or at a diluation of 10% or 30% in propylene glycol. Most solids can only applied at pastes of ca 25% content. The high concentration of 19% in water can only be achieved by the addition of 8% urea. Therefore 19% as highest concentration is seen as the highest attainable and therefore acceptable concentration for testing in the LLNA.
There was no increase in lymph node weight nor lymph node cell count. As a result, the substance was found to be a non skin sensitizer in the LLNA.
Experimental data from a guinea pig maximization test (OECD 406, GLP) is available for Direct Blue 199 as a mixed ammonium/sodium salt (BASF 1989). The test material had a purity of 83% and was applied at 1% and 10% for intradermal and epicutaneous induction, respectively. The challange concentration was 5% which was the highest non-irritating concentration. As no local reactions towards challenge exposure were observed, the substance was found to be non-skin sensitizing in the GPMT.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- non-radioactive version
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- Composition:
19% CAS 94543-99-3
72% Water
8% Urea - Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Age at the beginning of the study: about 8 weeks
Body weight range at day 0: 18.5 g - 22.2 g
The single housed animais were identif led by cage cards.
The animals were housed in fully air-conditioned rooms in which a central air-conditioning system ensured a temperature in the range of 20 - 24°C and a relative humidity in the range of 30 - 70%. The day/night rhythm was 12 h light and 12 h darkness.
Single housing in Makrolon type I cages.
Bedding: Granulat Typ 3/4 (staubfrei); SSNIFF
Type of diet: Kliba Labordiaet (Ratte-Maus-Hamster Haltungsdiaet), Provimi Kliba SA, Kaiseraugst, Switzerland ad libitum
Watering: Tap water ad libitum
Acclimatization period: At least 8 days before the first test substance application - Vehicle:
- propylene glycol
- Remarks:
- for the high dose, the test material was used in the pure form.
- Concentration:
- Undiluted or 10% or 30% in propylene glycol
Each test animal was applied with 25 uL per ear of the respective test substance / test substance preparation to the dorsum of both ears for three consecutive days. The control group was treated with 25 uL per ear of the vehiole alone.
19% is the solubility limit. Higher concentrations are not possible. - No. of animals per dose:
- 6
- Details on study design:
- The test substance preparations were produced on a weight by weight (wlw) basis shortly before the application by stirring with a magnetic stirrer.
The homogeneity of the test substance preparations during application was provided by stirring with a magnetic stirrer.
Form of test substance preparations: The test substance was applied undiluted resp. as an emulsion for all applications. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Parameter:
- SI
- Remarks:
- Cell count
- Value:
- 1.11
- Test group / Remarks:
- 10% in propylene glycol (1.9% of the substance)
- Parameter:
- SI
- Remarks:
- cell count
- Value:
- 0.97
- Test group / Remarks:
- 30% in propylene glycol (5.7% of the substance)
- Parameter:
- SI
- Remarks:
- cell count
- Value:
- 1.07
- Test group / Remarks:
- undiluted (19% of the test substance)
- Parameter:
- SI
- Remarks:
- Lymph node weight
- Value:
- 1.08
- Test group / Remarks:
- 10% in propylene glycol
- Parameter:
- SI
- Remarks:
- Lymph node weight
- Value:
- 1.17
- Test group / Remarks:
- 30% in propylene glycol
- Parameter:
- SI
- Remarks:
- Lymph node weight
- Value:
- 1.15
- Test group / Remarks:
- Undiluted (19% of the test substance)
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No signs of systemic toxicity were noticed. The test material (19% aquaeous formulation) did not induce a statistically significant and biologicaily relevant response of the auricular Iymph nodes when applied as 10% preparation in propylene glycol or applied as the undiluted test substance. The statisticaliy significant increase in lymph node weights of mice treated with the 30% test material preparation was not in congruency with the ceIl counts, which were not statisticaily significant at all concentrations. The ear weights did not indicate a significant Irritation of the ear skin by the test substance.
From the results of the study it is concluded, that the 19% aquaeous formulation does not have a skin sensitizing effect in the Murine Local Lymph Node Assay.
Reference
Table 1: Individual values for the lymph node weights
Test Group | Animal No. | Lymph Node Weight [mg] | ||
Individual | Mean | S.D. | ||
1 | 4.0 | |||
2 | 4.2 | |||
1 vehicle propylene glycol |
3 | 5.3 | 4.6 | 0.6 |
4 | 5 | |||
5 | 4.9 | |||
6 | 4.0 | |||
7 | 4.3 | |||
8 | 4.0 | |||
2 10% in propylene glycol |
9 |
5.8 |
5.0 | 0.7 |
10 | 5 | |||
11 | 5.5 | |||
12 | 5.1 | |||
13 | 5.3 | |||
14 | 4.3 | |||
3 30% in propylene glycol |
15 | 6.0 |
5.3 | 0.6 |
16 | 5.3 | |||
17 | 5.3 | |||
18 | 5.8 | |||
19 | 6.5 | |||
20 | 5.5 | |||
4 undiluted |
21 |
4.2 |
5.2 | 0.9 |
22 | 4.7 | |||
23 | 5.8 | |||
24 | 4.7 |
Table 2: Individual counts for the cell counts
Test Group | Animal No. | Cell Count [Count/Lymph Node Pair] | ||
Individual | Mean | s.d. | ||
1 | 7'062'000 | |||
2 | 8'380'000 | |||
1 vehicle propylene glycol |
3 | 9,538,000 |
7'968'333 | 1'179'450 |
4 | 8,524,000 | |||
5 | 8'118'000 | |||
6 | 6'188'000 | |||
7 | 6'646'000 | |||
8 | 6'160'000 | |||
2 10% in propylene glycol |
9 | 10,930,000 |
8'858'667 | 1'994'323 |
10 | 9,316,000 | |||
11 | 10'480'000 | |||
12 | 9'620'000 | |||
13 | 9'442'000 | |||
14 | 4'699'000 | |||
3 30% in propylene glycol |
15 |
7,558,000 |
7'733'500 | 1'695'198 |
16 | 7,760,000 | |||
17 | 7'722'000 | |||
18 | 9'220'000 | |||
19 | 12'858'000 | |||
20 | 7'420'000 | |||
4 undiluted |
21 |
6,826,000 |
8'506'000 | 2'390'135 |
22 | 6,246,000 | |||
23 | 9'222'000 | |||
24 | 8'464'000 |
s.d. = standard deviation
Table 3: Ear weights
Test Group | Treatment | Mean | S.D. | Index |
1 | vehicle propylene glycol | 27.4 | 0.9 | 1.00 |
2 | 10% in propylene glycol | 27.6 | 0.5 | 1.01 |
3 | 30% in propylene glycol | 28.4 | 1.7 | 1.04 |
4 | undiluted | 27.9 | 1.3 | 1.02 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The stimulation indices in the LLNA (OECD 429) did not show a dose dependent increase. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008,as amended for the seventh time in Regulation (EC) No 2015/1221.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.