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EC number: 269-246-6 | CAS number: 68201-95-6
- 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
Not skin sensitizing
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: experimental results on same main component, with a different counter ion. The different salificaton which does not influence the characteristics related to the specific end-point
- Adequacy of study:
- key study
- Study period:
- From January 8th to February 14th, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted May 12, 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A LLNA study has not been conducted because a adequate data from a previously conducted experiment already exists.
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI, SPF-quality (synonym: Himalayan spotted)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd.
- Age at delivery: 7 - 8 weeks
- Body weight at start of acclimatization: males 316 - 377 g, females 310 - 332 g
- Identification: by unique cage number and corresponding individual number of animals and restrainer.
- Randomization: randomly selected at time of delivery.
- Housing: individually in Makrolon type-3 cages with standard softwood bedding.
- Diet: pelleted standard Kliba 342, guinea pig breeding/ maintenance diet, ad libitum.
- Water : community tap water from Itingen, ad libitum.
- Acclimation period: 7 days under test conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40 - 70 %
- Air changes: 10-15 air changes per hour.
- Photoperiod: 12 hours artificial fluorescent light/12 hours dark, music/light period. - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- bi-distilled water
- Concentration / amount:
- Induction: 25 % test item in bi-distilled water
Challenge: 25 % test item in bi-distilled water - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- bi-distilled water
- Concentration / amount:
- Challenge: 25 % test item in bi-distilled water
- No. of animals per dose:
- Main test: 10 males and 10 females.
Pretest: 2 males and 2 females for induction and 2 males and 2 females for challenge. - Details on study design:
- RANGE FINDING TESTS
4 guinea pigs (2 males and 2 females) were used for pretest for induction and further 4 animals (2 males and 2 females) were used for pretest for challenge. The concentrations used for irritation screen for induction were 5, 10, 15 and 25 % of test item in bi-distilled water.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three inductions.
- Exposure period: about 6 hours (± 15 minutes) later, patches were removed.
- Test groups: 10 males and 10 females.
- Control group: untreated control animals.
- Site: fur was shaved the day before exposure. The area shaved was approximately one-fourth of the animals' back and side.
- Frequency: the patch application was repeated at the same site once a week for the next two weeks for a total of three 6-hour exposures.
- Evaluation: the responses were graded at 24 hours (± 2 hours) after patch removal.
After the last induction exposure, the animals were left untreated for two weeks before primary challenge.
B. CHALLENGE EXPOSURE
- Test groups: the animals previously exposed during the induction period (i.e. test group) were challenged two weeks after the last induction exposure using the dose as prescribed.
- Control group: 5 males and 5 females used for the first challenge treatment with test item. Further 5 males and 5 females,. due to the unequivocal findings observed after the first challenge no second challenge was performed. Cntrol animals were graded before the test animals. Grading of all animals was done by positioning the animal under true-light.
- Site: the challenge fur was clipped from the left posterior quadrant of the side and back of the animal.
- Evaluation: 18 to 22 hours after patches had been removed, all animals were depilated using an approved depilatory cream . The depilatory was placed on the patch sites and surrounding areas, and left on for 15 minutes or less. It was then thoroughly washed off with a stream of warm, running water. The animals were then dried with a disposable towel, and returned to their cages. A minimum of 2 hours after depilation (24 hour grade) the test sites were graded.
OBSERVATIONS
- Mortality/Viability: daily.
- Body weights: at acclimatization start, at day one (induction start) and at termination of the test.
- Symptoms (local/systemic): daily, including irritation effects during induction period.
PATHOLOGY
No necropsy was performed in the animals killed at termination of observation. All animals were killed at the end of the test period with an intra-peritoneal injection of T61 (Hoechst AG) and discarded. - Challenge controls:
- Control group for 1st challenge: 5 / sex / dose
Control group for 2nd challene: 5 / sex / dose - Positive control substance(s):
- yes
- Remarks:
- Formaldehyde solution
- Positive control results:
- In a separate test (between November and December, 1989), the incidence to allergenic reactions of the guinea pig strain used, was tested with a known allergen (the positive control). Significant positive results were obtained in this experiment.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None, except for staining around the epidermal induction sites, application area
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None, except for staining around the epidermal induction sites, application area
- Interpretation of results:
- not sensitising
- Remarks:
- according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not sensitising
- Executive summary:
The allergenic potential of the test substance was examined in a modified Buehler test according to OECD test guideline 406. 2 animals per sex were used in an irritation screen for induction and irritation screen for challenge. 4 test substance concentrations were applied at different sites on each animal: 25 %, 15 % , 10 % and 5 %. A concentration of 25 % was chosen for induction and challenge based on the results of the irritation screen for induction. In the main study, the control group consisted of 5 animals per sex per dose and the test group consisted of 10 animals per sex per dose. The exposure period was 6 h in the irritation screens, induction and challenge tests. Erythema and edema was scored at 24 h and 48 h. Mortality/viability, bodyweights and local/systemic symptoms were observed during the study. No necropsy was performed in the animals killed at termination of observation. All animals were killed at the end of the test period with an intra-peritoneal injection of T61 (Hoechst AG) and discarded.
No mortality occurred during the study. Bodyweight gain of all animals was unaffected during the study. The application area around the epidermal induction sites showed staining around day 2 to day 26. No systemic symptoms were observed in any animal in the study. No skin reactions were observed in the irritation screen for induction and irritation screen for challenge. 25 % was determined to be the highest non-irritating concentration. Each animal was exposed to the test substance once a week for 3 weeks in induction. In the first induction week, no skin reaction was observed. In the second induction week, no edema was observed and 3 female guinea pigs showed slight erythema or moderate but patchy erythema. In the third induction week, no edema was observed and 1 male guinea pig showed slight erythema or moderate but patchy erythema.
Challenge took place 2 weeks after the last induction exposure. In the first challenge, no skin reaction occurred at 24 h or 48 h in all animals in the control group and test group. No second challenge was performed because of unequivocal findings from the first challenge.
Conclusion
The test substance is not a skin sensitiser.
Reference
Induction
Induction week 1: no erythema or edema was recorded in all 20 animals in the test group.
Induction week 2: slight confluent, or moderate but patchy erythema was observed in 3 female rabbits. No edema was recorded in all guinea pigs.
Induction week 3: slight confluent, or moderate but patchy erythema was observed in 1 male rabbit. No edema was observed in all guinea pigs.
Skin reactions observed during induction (25 % test article)
Animal N. | Sex | Induction week 1 | Induction week 2 | Induction week 3 | |||
Erythema | Oedema | Erythema | Oedema | Erythema | Oedema | ||
241 | M | 0 | 0 | 0 | 0 | 0 | 0 |
242 | M | 0 | 0 | 0 | 0 | 0 | 0 |
243 | M | 0 | 0 | 0 | 0 | 0 | 0 |
244 | M | 0 | 0 | 0 | 0 | 0 | 0 |
245 | M | 0 | 0 | 0 | 0 | 0 | 0 |
246 | M | 0 | 0 | 0 | 0 | 0 | 0 |
247 | M | 0 | 0 | 0 | 0 | 0 | 0 |
248 | M | 0 | 0 | 0 | 0 | 0 | 0 |
249 | M | 0 | 0 | 0 | 0 | 0 | 0 |
250 | M | 0 | 0 | 0 | 0 | 1 | 0 |
261 | F | 0 | 0 | 0 | 0 | 0 | 0 |
262 | F | 0 | 0 | 1 | 0 | 0 | 0 |
263 | F | 0 | 0 | 0 | 0 | 0 | 0 |
264 | F | 0 | 0 | 0 | 0 | 0 | 0 |
265 | F | 0 | 0 | 1 | 0 | 0 | 0 |
266 | F | 0 | 0 | 0 | 0 | 0 | 0 |
267 | F | 0 | 0 | 1 | 0 | 0 | 0 |
268 | F | 0 | 0 | 0 | 0 | 0 | 0 |
269 | F | 0 | 0 | 0 | 0 | 0 | 0 |
270 | F | 0 | 0 | 0 | 0 | 0 | 0 |
Challenge
First challenge control group: no erythema or edema occured after 24 h (± 2 h) or 48 h (± 2 h) in all rabbits.
First challenge test group: no erythema or edema occured after 24 h (± 2 h) or 48 h (± 2 h) in all rabbits.
Second challenge: due to unequivocal findings observed after the first challenge, no second challenge was performed.
Test group (20 animals) | Control group (10 animals) | |||
Score | 24 hrs | 48 hrs | 24 hrs | 48 hrs |
0 | 20 | 20 | 10 | 10 |
0* | 0 | 0 | 0 | 0 |
1 | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 0 | 0 |
3 | 0 | 0 | 0 | 0 |
N. with grades ≥ 1 | 0 | 0 | 0 | 0 |
N. tested | 20 | 20 | 10 | 10 |
Total | 0 | 0 |
*The total is the number of animals showing a grade ≥ 1 at either 24 or 48 hours.
OBSERVATION
Viability / Mortality: no death occurred during the study.
Bodyweights: the body weight gain of the animals was not affected during the study.
Local symptoms in the test group: application area around the epidermal induction sites was found to show staining from day 2 to 26.
Systemic symptoms: no systemic symptoms were observed in any animal during the study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The allergenic potential was examined in a modified Buehler test according to OECD test guideline 406. The experiment was conducted on Direct Red 253 sodium and triethanolammonium salt, which has the same main component of the substance under registration (i.e. Direct Red 253) with a different counter ion. The information can be considered as suitable and appropriated because the difference in salification is expected to not influence the characteristics related to the specific end-point.
A concentration of 25 % was chosen for induction and challenge based on the results of the irritation screen for induction. In the main study, the control group consisted of 5 animals per sex per dose and the test group consisted of 10 animals per sex per dose. The exposure period was 6 h in the irritation screens, induction and challenge tests. Mortality/viability, bodyweights and local/systemic symptoms were observed during the study. No necropsy was performed in the animals killed at termination of observation.
No mortality occurred during the study. Bodyweight gain of all animals was unaffected during the study. The application area around the epidermal induction sites showed staining around day 2 to day 26. No systemic symptoms were observed in any animal in the study. No skin reactions were observed in the irritation screen for induction and irritation screen for challenge. 25 % was determined to be the highest non-irritating concentration. Each animal was exposed to the test substance once a week for 3 weeks in induction. In the first induction week, no skin reaction was observed. In the second induction week, no edema was observed and 3 female guinea pigs showed slight erythema or moderate but patchy erythema. In the third induction week, no edema was observed and 1 male guinea pig showed slight erythema or moderate but patchy erythema.
Challenge took place 2 weeks after the last induction exposure. In the first challenge, no skin reaction occurred at 24 h or 48 h in all animals in the control group and test group. No second challenge was performed because of unequivocal findings from the first challenge (Ullmann, 1990).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), 3.4 Respiratory or skin sensitisation section, skin sensitizer means a substance that will lead to an allergic response following skin contact.
For a non-adjuvant Guinea pig test method a response of at least 15 % of the animals is considered positive.
Based on the read across approach, Direct Red 253 (DR253) can be considered as non skin sensitizer.
In conclusion, the substance does not meet the criteria to be classified as skin sensitizer, according to the CLP Regulation (EC 1272/2008).
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