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EC number: 274-492-2 | CAS number: 70236-62-3
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo study are available.
Test material
- Reference substance name:
- Acid Brown 298
- IUPAC Name:
- Acid Brown 298
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at beginning of acclimatization period: 5 -7 weeks
- Body weight at beginning of acclimatization period: control and test group 291 - 374 g; pretest 292 - 364 g.
- Acclimatation: one week for the control and test group under test conditions after health examination. No acclimatization for the animals of the pretest. Only animals without any visual signs of illness were used for the study.
- Accommodation: individually in Makrolon type-3 cages (size: 22 x 37 x 15 cm) with autoclaved standard softwood bedding
- Diet: pelleted standard Kliba 342, Batch no. 63/94 guinea pig breeding/ maintenance diet ("Kliba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum.
- Water: community tap water from Füllinsdorf, ad libitum. Once weekly additional supply of ascorbic acid (1 g/l) via the drinking water.
ENVIRONMENTAL CONDITIONS
Air-conditioned with 10-15 air changes per hour and continuously monitored environment with a temperature between 21 and 25 °C, a relative humidity between 52 and 70 %, 12 hours artificial fluorescent light (approx. 100 Lux) /12 hours dark, music during the light period.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Remarks:
- bi-distilled
- Concentration / amount:
- PRETEST:
- Intradermal injections (0.1 ml/site) were made into the clipped flank of two guinea-pigs at concentrations of 5, 3 and 1 % of the test article in bi-distilled water.
- Epidermal application: 4 patches* of filter paper ( 2 x 2 cm) were saturated with the test article at
A = 25 % (this concentration used was found to be the most qualified to assure an optimum technical application procedure),
B = 15 %,
C = 10 % and
D = 5 %
of the test article in bi-distilled water and applied to the clipped and shaved flanks.
MAIN STUDY:
- 0.5 ml per animal of the test article in a 1 % (W/W) solution in water for injection.
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- bi-distilled
- Concentration / amount:
- PRETEST:
- Intradermal injections (0.1 ml/site) were made into the clipped flank of two guinea-pigs at concentrations of 5, 3 and 1 % of the test article in bi-distilled water.
- Epidermal application: 4 patches* of filter paper ( 2 x 2 cm) were saturated with the test article at
A = 25 % (this concentration used was found to be the most qualified to assure an optimum technical application procedure),
B = 15%,
C = 10% and
D = 5%
of the test article in bi-distilled water and applied to the clipped and shaved flanks.
MAIN STUDY:
- 0.5 ml per animal of the test article in a 1 % (W/W) solution in water for injection.
- No. of animals per dose:
- • preliminary studies (minimum of 3) : 2 males, 2 non-pregnant females, per study.
• main study :
- control group -> 5 males, 5 nulliparous non-pregnant females.
- treated group -> 10 males, 10 nulliparous non-pregnant females. Two extra guinea-pigs (1 male and 1 female) will also be treated to allow for any possible non-treatment related deaths.
- option : positive control group -> 5 males, 5 nulliparous non-pregnant females. - Details on study design:
- During induction, the applications were performed as follows :
• Treated group :
- By intradermal route: 3 series of 2 x 0.1 ml injections
Freund's complete adjuvant at 50 % (V/V) in an isotonic injectable solution;
test article in a 5 % (w/w) suspension in water for injection;
mixture 50/50 (V/V): test article in a 5 % (w/w) suspension in water for injection + Freund's complete adjuvant at 50 % (V/V) in an isotonic injectable solution, i.e. a final 2.5 % concentration of the test article .
During the preliminary study, injection of the test article in a 5 % suspension tinted the skin of the animals thus making observation of erythema impossible. No oedema was noted.
- By topical occlusive route for 48 hours, with 0.5 ml of the test article in a 57 % (w/w) paste in water for injection.
During the preliminary study, the test article tinted the skin of the animals thus making observation of erythema impossible. Nevertheless as no oedema was noted, a skin painting was performed during the main study on Day 8, with 0.5 ml of sodium lauryl sulphate at 10 % (w/w) in Codex paraffin to create irritation.
• Control group:
The intradermal injections and the topical occlusive application for 48 hours were carried out under the same conditions as in the treated group, water for injection replacing the test article.
The rest period was 11 days without treatment.
During the challenge, the topical occlusive application for 24 hours was performed in the treated group and in the control group with the test article in a 1 % (w/w) solution in water for injection and at the dose level of 0.5 ml. The cutaneous macroscopic examinations were performed 24 and 48 hours after removal of the patches to the challenge application site, according to the Magnusson & Kligman scale.
As the test article tinted the skin of the animals, thus making observation of erythema impossible, histopathological examinations of the skin were performed for all the animals of the treated and control groups (in half of them at 24 hours and in the other half at 48 hours). - Positive control substance(s):
- yes
- Remarks:
- 2,4-Dinitrochlorobenzene
Results and discussion
- Positive control results:
- 80 to 100 % of sensitized animals are usually obtained.
In vivo (non-LLNA)
Results
- Remarks on result:
- other: 1 animal out 20 showed positive reactions
Any other information on results incl. tables
Treated groups:
Biopsies performed at 24 hours | Biopsies performed at 48 hours | ||||||||||
Animal (sex,number) | M62531 | M62533 | M62535 | M62537 | M62539 | M62534 treated area | M62534 control area | M62536 | M62538 | M62540 | M6262541 |
EPIDERMIS | |||||||||||
Acanthosis | moderate | minimal | minimal | minimal | slight | slight | slight | minimal | slight | minimal | slight |
Hyperkeratosis | moderate | slight | slight | moderate | moderate | moderate | moderate | marked | moderate | moderate | marked |
Exocytosis | minimal (focal) | - | - | - | - | minimal (focal) | - | - | - | - | - |
Spongiosis | minimal (basal) | - | - | - | minimal (basal) | minimal (focal) | - | - | - | - | - |
DERMIS | |||||||||||
Mononuclear cell infiltration | slight | slight | slight | slight | slight | slight | slight | slight (1) | slight | slight | slight |
Folliculitis | - | - | - | - | minimal | - | - | - | - | - | - |
Oedema | minimal | - | - | - | - | - | - | - | - | - | - |
Biopsies performed at 24 hours | Biopsies performed at 48 hours | ||||||||||
Animal (sex,number) | F62543 | F62545 | F62547 treated area | F62547 control area | F62549 | F62551 | F62542 | F62544 | F62546 | F62548 | F62550 |
EPIDERMIS | |||||||||||
Acanthosis | slight | slight | minimal | slight | slight | moderate | slight | minimal | slight | minimal | slight |
Hyperkeratosis | moderate | moderate | moderate | moderate | moderate | marked | moderate | moderate | moderate | moderate | moderate |
Exocytosis | - | - | - | minimal (multifocal) | - | - | - | - | - | - | - |
Spongiosis | - | - | - | minimal (basal) | - | - | - | - | - | - | - |
Scab(s) | - | present | - | - | - | - | present | - | - | - | - |
Ulceration | - | minimal (focal) | - | - | - | - | - | - | - | - | - |
DERMIS | |||||||||||
Mononuclear cell infiltration | slight | slight (1) | minimal | slight (1) | slight | slight | slight | slight | slight | slight | slight |
Folliculitis | - | - | - | - | - | - | - | - | - | minimal | - |
Oedema | - | - | - | - | - | - | - | - | - | - | - |
Control group:
Biopsies performed at 24 hours | Biopsies performed at 48 hours | |||||||||
Animal (sex,number) | M62521 | M62523 | M62525 | F62527 | F62529 | M62522 | M62524 | M62526 | F62528 | F62530 |
EPIDERMIS | ||||||||||
Acanthosis | minimal | - | minimal | slight | slight | minimal | minimal | slight | minimal | slight |
Hyperkeratosis | slight | slight | moderate | moderate | moderate | moderate | moderate | moderate | moderate | moderate |
Exocytosis | - | - | - | - | minimal (focal) | minimal (focal) (1) | - | - | - | - |
Spongiosis | - | - | - | - | minimal (basal) | slight (focal) | - | - | - | - |
scab(s) | - | - | - | - | - | - | - | - | - | present |
DERMIS | ||||||||||
Mononuclear cell infiltration | minimal | minimal | minimal | slight | slight | slight | slight | slight | slight | slight |
Folliculitis | - | - | - | - | - | - | - | minimal (focal) | - | minimal (focal) |
Oedema | - | - | - | - | - | - | - | - | - | - |
(1) with some polymorphs
Male no. 62534 showed on the treated area a minimal focus of spongiosis associated with exocytosis which could be due to cell mediated delayed hypersensitivity. Other changes seen in all animals were consistent with a minimal to slight local irritation due to the technical procedures.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to the CLP Regulation
- Conclusions:
- Not sensitising
- Executive summary:
METHOD:
The guinea pig maximisation test (GPMT) was chosen as test method used to evaluate skin sensitisation potential. The test was performed according to the OECD Guideline 406 (1992).
RESULTS:
Signs of irritation were noted during induction after application of sodium lauryl sulphate in both groups.
After challenge, the macroscopic and histopathological examinations revealed pathological lesion of delayed hypersensitivity in 1 out of the 20 treated animals. No noticeable cutaneous abnormality was noted in the 10 guinea-pigs examined in the control group.
CONCLUSION:
According to the CLP Regulation (EC n. 1272/2008), a substance is classified as skin sensitiser when in the Guinea pig maximisation test the response of at least 30 % of the animals is considered as positive.
The percentage of sensitization reaction obtained (10 %) does not justify a classification as sensitising substance, according to the CLP Regulation (EC n. 1272/2008).
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