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EC number: 279-087-4 | CAS number: 79135-87-8
- 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 sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From March the 17th to Apri the 21st, 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- Justification for read across is detailed in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted on 12 May, 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An appropriate guinea pig maximisation test was already avaiable, which would not justify conducting an additional LLNA due to animal welfare.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, West Germany.
- Age at start of treatment: ca. 11 weeks.
- Weight at study initiation: 288 - 424 g
- Diet: free access to standard guinea pig diet including ascorbic acid (1600 mg/kg); once a week hay was provided. Certificate of analysis was performed.
- Water: free access to tap-water, diluted with decalcified water. Certificate of analysis was performed.
- Accomodation: group housing of 2 animals per cage with wire-mesh floors (ITL, Bergen).
- Acclimation: at least 5 days, physical examination performed.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 7.5 - 15 ACH
- Photoperiod: 12 hours dark. - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5 % w/w test article
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 % w/w test article
- Day(s)/duration:
- 48 hours
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- vehicle and 25, 10, 5 % test article / 0.05 ml each
- Day(s)/duration:
- 24 hours
- No. of animals per dose:
- PRELIMINARY TEST: 5 animals
MAIN TEST: 10 animals for control and 20 animals for experimental group - Details on study design:
- RANGE FINDING TESTS - PRIMARY IRRITATION EXPERIMENT
- Induction application: intradermal and epidermal
Intradermal injections: 4 sites with 0.1 ml/site at 5 % w/w test article concentration.
Epidermal applications: left flank treated with 0.5 ml of 50 % concentration in milli-RO water; held with Coban elastic bandage for 24 hours.
- Challenge application: left flank treated with 0.05 ml of 50, 25, 10 and 5 % concentration in milli-RO water; held with Coban elastic bandage for 24 hours.
- Symptoms evaluated: erythema/necrosis and diameter for intradermal; checked after 24 and 48 hours.
MAIN STUDY
A1 INDUCTION EXPOSURE - Intradermal injections
- Site: scapular region; 4x6 cm clipped free of hair.
- Injections: 3 pairs at 0.1 ml/site
Test article: 5 % w/w with physiological saline.
FCA: 50:50 with distilled water.
Test article: 10 % w/w emulsified in 50:50 mixture of FCA.
A2 INDUCTION EXPOSURE - Epidermal applications (7 days after intradermal induction)
- Site: same scapular area, 4x6 cm clipped and shaved free of air.
- Concentration: 0.5 ml milli-RO water at 25 % w/w test article
- Bandage: micropore tape firmly secured with Coban elastic bandage.
- Duration: 48 hours
- Evaluation: reaction sites were checked for erythema and oedema immediately after removal of dressing.
B. CHALLENGE EXPOSURE (14 days after epidermal induction)
- Exposure period: 24 hours.
- Test group: 20 females.
- Control group: 10 females; treated as the same way by intradermal and epidermal inductions with the omission of test article.
- Site: 5x5 cm area on the left flank of each animal.
- Concentrations: milli-Ro water and 3 test article concentrations at 25, 10, 5 % in milli-RO water.
- Amount: 0.05 ml of each concentration.
- Bandage: micropore tape firmly secured with Coban elastic bandage.
- Evaluation: sites were assessed for swelling and redness 24 and 48 hours after removal. Positive skin reaction (grade 2 or more) were considered signs of sensitization. The sensitization rate by comparison with control group was then calculated.
OTHER
Used scoring system [Klingman et al., 1966].
No skin reaction............................. 0
Red spots.......................................1
Moderate but confluent redness....2
Redness and swelling....................3
Intense reddening and swelling........4 - Challenge controls:
- A positive control experiment is carried out once a year as a sensitivity check of the test system. The most recent test was carried out in December, 1988; performed under GLP conditions with a QA-check.
- Positive control substance(s):
- yes
- Remarks:
- formaldehyde
- Positive control results:
- Clearly positive results (90 % sensitisation rate) were obtained in the exporimental animals after challenge with 0.5 % w/w formaldehyde.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % test article
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- No additional animal showed a numerical score value higher than 2.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.5 %
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) 1272/2008
- Conclusions:
- Not skin sensitising
- Executive summary:
The Guinea Pig Maximisation Test was performed according to OECD 406 (1981). A total of 35 females were used, 20 for the main study and 10 for the control. The other 5 animals were used for the primary irritation experiment.
The induction phase was accomplished by both intradermal and epicutaneous application. In the challenge phase, the test substance resulted in a sensitisation rate of 5 %, when tested at the maximum testable epidermal application of 25 % w/w test article.
Conclusion
Less than 30 % of the tested population showed positive reactions, responding to an intradermal induction dose higher than 1 %.
Reference
Summary table of positive reactions to the challenge
Test article concentration | ||||
25 % | 10 % | 5 % | 0 % | |
EXPERIMENTAL GROUP | ||||
No. animals with positive reaction | 1 | 0 | 0 | 0 |
Sensitisation rate | 5 | 0 | 0 | 0 |
CONTROL GROUP | ||||
No. animals with positive reaction | 0 | 0 | 0 | 0 |
Individual induction and challenge readings
EXPERIMENTAL GROUP | ||||||||||||
Animal no. | Readings of induction (day 10) | Challenge | Sensitised | |||||||||
1st reading | 2nd reading | |||||||||||
Erythema | Oedema | 25 % | 10 % | 5 % | 0 % | 25 % | 10 % | 5 % | 0 % | |||
306 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | no | |
307 | 0 | 1 | 2 | 0 | 0 | 0 | 1s | 0 | 0 | 0 | yes | |
308 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | no | |
309 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | no | |
310 | 1 | 1 | 0 | 0 | 0 | 0 | 1s | 1 | 1s | 0 | no | |
311 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | no | |
312 | 0 | 0 | 1 | 0 | 0 | 0 | 1s | 0 | 0 | 0 | no | |
313 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | no | |
314 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | no | |
315 | 1 | 1 | 1 | 1 | 0 | 0 | 1s | 1 | 0 | 0 | no | |
316 | 0 | 0 | 1 | 0 | 0 | 0 | 1cs | 0 | 0 | 0 | no | |
317 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | no | |
318 | 2 | 2 | 0 | 0 | 0 | 0 | 0s | 0 | 0 | 0 | no | |
319 | 2 | 1 | 0 | 0 | 0 | 0 | 0s | 0 | 0 | 0 | no | |
320 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | no | |
321 | 1 | 1 | 1 | 0 | 0 | 0 | 1s | 0 | 0 | 0 | no | |
322 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | no | |
323 | 1 | 1 | 1 | 0 | 0 | 0 | 1s | 0 | 0 | 0 | no | |
324 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | no | |
325 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | no | |
CONTROL GROUP | ||||||||||||
Animal no. | Readings of induction (day 10) | Challenge | Sensitised | |||||||||
1st reading | 2nd reading | |||||||||||
Erythema | Oedema | 25 % | 10 % | 5 % | 0 % | 25 % | 10 % | 5 % | 0 % | |||
326 | 0 | 0 | 0 | 0 | 0 | 0 | 1s | 0 | 0 | 0 | no | |
327 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | no | |
328 | 0 | 0 | 0 | 0 | 0 | 0 | 1s | 0 | 0 | 0 | no | |
329 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | no | |
330 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | no | |
331 | 0 | 0 | 1 | 0 | 0 | 0 | 1s | 0 | 0 | 0 | no | |
332 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | no | |
333 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | no | |
334 | 0 | 0 | 0 | 0 | 0 | 0 | 1s | 0 | 0 | 0 | no | |
335 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | no |
Legend:
s = scaliness
c= crust formation
PRIMARY IRRITATION EXPERIMENT
25% (w/w) was chosen as the highest usable test article concentration, due to the fact that the 50% concentration was a much to solid suspension. No signs of systemic toxicity were observed during the primary irritation experiments, except of body weight loss in one animal.
OTHER FINDINGS
The average body weight gain of the experimental animals was approximately 30 % smaller than the average body weight gain of the control animals. However, body weights measured during the acclimatisation period were noted as being slightly low for animals assigned to the control group. These animals would therefore be expected to gain more weight than the animals assigned to the experimental group. Differences in body weight gain are therefore not considered to have arisen as a result of treatment.
No symptoms of systemic toxicity were observed.
No positive skin reaction were evident after the challenge exposure.
Positive control results (1988 test)
Formaldehyde concentration | ||||
0.50% | 0.25% | 0.10% | 0% | |
EXPERIMENTAL GROUP | ||||
No. Animals with positive reaction | 18 | 7 | 1 | 0 |
Sensitisation rate | 90 | 35 | 5 | 0 |
CONTROL GROUP | ||||
No. Animals with positive reaction | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There is no information about the skin sensitisation potential of Optical Brightener 380, thus the available data on the structural analogous Similar Substance 01 have been taken into consideration for the assessment.
The read across approach can be considered reliable and appropriate to investigate the property (details for the approach are included into the IUCLID section 13).
The Guinea Pig Maximisation Test was performed according to OECD 406 (1981). A total of 35 females were used, 20 for the main study and 10 for the control. The other 5 animals were used for the primary irritation experiment.
The induction phase was accomplished by both intradermal and epicutaneous application. In the challenge phase, the test substance resulted in a sensitisation rate of 5 %, when tested at the maximum testable epidermal application of 25 % w/w test article.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the CLP Regulation (EC) No 1272/2008, 3.4 Respiratory or skin sensitisation section, skin sensitizer means a substance that will lead to an allergic response following skin contact.
Based on the Guinea Pig Maximisation Test (GPMT) results, a substance in considered a skin sensitizer when equal or more than 30 % to 60 % responding at intradermal induction dose > 0.1 % to ≤ 1 %; or equal or more than 30 % responding at intradermal induction dose higher than 1 %.
In the available experiment, less than 30 % of the tested population showed positive reactions, responding to an intradermal induction dose higher than 1 %.
In conclusion, Optical Brightener 380 is considered to not meet the criteria to be classified as skin sensitizer, according to the CLP Regulation (EC) No 1272/2008.
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