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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 413-550-5 | CAS number: 142068-96-0 H112339
- 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
- Study period:
- November - December 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with GLP, however no EU test guidance is referenced within the study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Buehler E V (1965).
- Deviations:
- no
- Principles of method if other than guideline:
- No EU test guideline referenced within the study report; however the method is specified as based on the Buehler method. Examination of the report indicates that this is equivalent to OECD Guideline 406 (Skin Sensitisation), the Buehler method.
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Octasodium 2-(8-(4-chloro-6-(3-((4-chloro-6-(3,6-disulfonato-2-(1,5-disulfonatonaphthalen-2-ylazo)-1-hydroxynaphthalen-8-ylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,6-disulfonato-1-hydroxynaphthalen-2-ylazo)naphthalene-1,5-disulfonate
- EC Number:
- 413-550-5
- EC Name:
- Octasodium 2-(8-(4-chloro-6-(3-((4-chloro-6-(3,6-disulfonato-2-(1,5-disulfonatonaphthalen-2-ylazo)-1-hydroxynaphthalen-8-ylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,6-disulfonato-1-hydroxynaphthalen-2-ylazo)naphthalene-1,5-disulfonate
- Cas Number:
- 142068-96-0
- Molecular formula:
- Hill formula: C53H28Cl2N14Na8O26S8
- IUPAC Name:
- octasodium 5-[(4-chloro-6-{[4-({[4-chloro-6-({7-[2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-8-hydroxy-3,6-disulfonatonaphthalen-1-yl}amino)-1,3,5-triazin-2-yl]amino}methyl)phenyl]amino}-1,3,5-triazin-2-yl)amino]-3-[2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate
- Details on test material:
- The test sample (reference: NBY 405/74) was received as a dark brown powder. It was sent for testing from ICI ' Specialties, Blackley, Manchester, UK, A certificate of analysis (reference: 9108127, dated 8 August 1991) stated that the test sample contained 71,6% w/w substance H112339. From information supplied by the sponsor the test sample was used within the stated expiry date, The test sample was given the CTL reference number Y07719/Q01 and was tested either as a paste or a solution in deionised water.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Barriered Animal Breeding Unit, ICI Pharmaceuticals
- Age at study initiation: Young adults
- Weight at study initiation: 391-556g
- Housing: The guinea pigs were housed individually in suspended cages (32.5cm x 37.5cm x 23cm), The cage was constructed from stainless steel with two solid sheet sides, with the front, floor and rear being wire mesh.
- Diet (e.g. ad libitum): RGP Diet, ad libitum
- Water (e.g. ad libitum): via an automatic system, ad libitum
- Acclimation period: minimum of six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19(±2°C)
- Humidity (%): 55 (±15%)
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): controlled by a time switch to give alternate periods of 12 hours of artificial Ifght and 12 hours of darkness.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- SIGHTING STUDY
Challange Stage: 75%, 30%, 10% and 3% w/v preparation of the test sample in deionised water
Induction stage: 75% and 30% w/v preparation
MAIN STUDY
Induction: either a 75% w/v preparation (approximately 400mg) (test-group) or approximately 0.4ml of deionised water only (control animals).
Challange: Preparations (75%, 30%, 10% and 3% w/v) of the test sample in deionised water (approximately 0.1-0.2ml of a liquid or 100-200mg of a paste)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- SIGHTING STUDY
Challange Stage: 75%, 30%, 10% and 3% w/v preparation of the test sample in deionised water
Induction stage: 75% and 30% w/v preparation
MAIN STUDY
Induction: either a 75% w/v preparation (approximately 400mg) (test-group) or approximately 0.4ml of deionised water only (control animals).
Challange: Preparations (75%, 30%, 10% and 3% w/v) of the test sample in deionised water (approximately 0.1-0.2ml of a liquid or 100-200mg of a paste)
- No. of animals per dose:
- A group of thirty female guinea pigs was used for the main study, twenty test and ten control
- Details on study design:
- The sensitisation potential of the formulation was assessed using a method based on that described by Buehler (1965).
Each animal was given a number, unique within the study, which was written both on a small area of clipped, flank, using a black waterproof marker-pen, and on the cage card. The bodyweight of each animal was recorded at the start and end of the study.
Sighting Study; The dose levels for the induction and challenge stages of this study were determined by a sighting study.
Challenge Stage
The test sample as. a 75%, 30%, 10% and 3% w/v preparation of the test sample in deionised water was applied to each of two guinea pigs, as described in the main study. The test sample stained the skin and prevented a full assessment of skin irritation. As no overt signs of irritation were observed at any concentration, animals in the main study were challenged with all concentrations tested in the sighting study.
Induction Stage
With reference to the results of the challenge 'sighting' stage, two concentrations of the test sample (a 75% and 30% w/v preparation) were applied to each of two female guinea pigs as described in the main study, except that they were applied to the flanks not the scapular region. The test sample stained the skin and prevented the assessment of skin irritation. As no signs of irritation were visible at any concentration, animals in the main study were induced with a 75% w/v preparation of the test sample in deionised water.
Main Study: A group of thirty female guinea pigs was used for the main study, twenty test and ten control. The study involved two main procedures, the potential induction of an immune response and a challenge of that response.
Induction
An area approximately 5cm x 5cm on the scapular region of each animal was clipped free of hair with a pair of veterinary clippers and treated with a topical application of. either a 75% w/v preparation (approximately 400mg) (test-group) or approximately 0.4ml of deionised water only (controlanimals). The preparation was applied to a lint patch (approximate size 2cm x 2cm) which was covered with adhesive tape, and held in place by an adhesive elastic bandage (approximate size 20-3Qcm x 5cm) secured by a piece of PVC tape.
This occlusive dressing was left in place for approximately six hours. The induction procedure was repeated at the Same site during the next two weeks, giving a total of three six-hour exposures. The interval between each exposure was 7 days. Clinical observations were noted approximately 1 day after the removal of each patch and before application of each subsequent patch. The animals were re-clipped prior to the application of the formulation.
The animals were left untreated for two weeks after the final induction exposure, prior to challenge.
Challenge
An area approximately 15cm x 5cm on both flanks of each animal was clipped free of hair with a pair of veterinary clippers. An occlusive dressing was prepared which consisted of two lint patches (approximate size 1cm x 2cm) stitched to a piece of rubber sheeting (approximate size 5cm x 12cm),
Preparations (75%, 30%, 10% and 3% w/v) of the test sample in deionised water (approximately 0,1-0.2ml of a liquid or 100-20Qmg of a paste) were each applied to one of four lint patches. The dressings were placed on to the guinea pig so that-the 75% w/v preparation was on the top left shorn flank, the 30% w/v preparation was on the bottom left shorn flank, the 10% w/v preparation was on the top right shorn flank and the 3% w/v preparation was on the bottom right shorn flank. The dressing was held in place by adhesive impermeable polyethylene tape (approximate size 30cm x 7.5cm).
The patches were left in position for approximately six hours. The dressings were then cut, using blunt-tipped scissors, removed and discarded. The positions of the application sites were identified using a black waterproof marker pen.
Erythematous reactions were quantified and recorded, using a four point scale approximately 1 and 2 days after removal of the dressings. When necessary the animals were re-clipped prior to the 1 day reading.
To classify the sensitisation response, the percentage of the control animals that responded was subtracted from the percentage of test animals that responded and the net response was compared to the allocated scale
Formaldehyde (Positive Control): The sensitising potential of a 40% w/v aqueous formaldehyde solution was assessed using a method based on that described by Buehler (1965).
The solution was applied as a 30% w/v dilution in deionised water for both the induction and challenge phases. - Challenge controls:
- 75%, 30%, 10% and 3% w/v preparation of the test sample in deionised water was applied to each of two guinea pigs
- Positive control substance(s):
- yes
- Remarks:
- Formaldehyde
Study design: in vivo (LLNA)
- Concentration:
- Not applicable
- No. of animals per dose:
- Not applicable
- Details on study design:
- Not applicable
- Statistics:
- Not applicable
Results and discussion
- Positive control results:
- Signs of moderate irritation, including scabbing, thickening of the skin, desquamation, oedema and erythema were seen in test animals during the induction phase of the study. No signs of skin irritation were seen in any of the control animals.
Following challenge with a 30% w/v preparation of a formaldehyde solution (40% w/v in water), scattered mild redness to moderate diffuse redness was seen in nineteen out of twenty test animals. Scattered mild redness was observed in four out of ten control animals. The net percentage response was calculated to be 55%.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Test sample stained the skin 20/20 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 20/20 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Test sample stained the skin 20/20 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 20/20 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Test sample stained the skin 20/20 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 20/20 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Test sample stained the skin 20/20 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 20/20 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Test sample stained the skin 8/20 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 8/20 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Test sample stained the skin 9/20 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 9/20 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Test sample stained the skin 17/20 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 17/20 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Test sample stained the skin 17/20 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 17/20 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Test sample stained the skin 10/10 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 10/10 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Test sample stained the skin 10/10 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 10/10 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Test sample stained the skin 5/10 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 5/10 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Test sample stained the skin 4/10 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 4/10 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Test sample stained the skin 3/10 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 3/10 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Test sample stained the skin 3/10 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 3/10 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Test sample stained the skin 3/10 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 3/10 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Test sample stained the skin 3/10 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 3/10 animals.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Not applicable
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Not applicable
Any other information on results incl. tables
MAIN STUDY – CHALLENGE RESULTS
Challenge concentrations: 75% w/v in deionised water
30% w/v in deionised water
10% w/v in deionised water
3% w/v in deionised water
Animal Number |
Test Animals |
|||||||
75% w/v |
30% w/v |
10% w/v |
3% w/v |
|||||
24h |
48h |
24h |
48h |
24h |
48h |
24h |
48h |
|
61 |
*0 |
*0 |
0 |
0 |
*0 |
*0 |
** |
** |
62 |
*0 |
*0 |
0 |
0 |
** |
*0 |
0 |
0 |
63 |
*0 |
*0 |
*0 |
*0 |
*0 |
*0 |
*0 |
*0 |
64 |
*0 |
*0 |
0 |
0 |
** |
** |
** |
** |
65 |
*0 |
*0 |
0 |
0 |
0 |
0 |
** |
** |
66 |
*0 |
*0 |
0 |
0 |
0 |
0 |
*0 |
*0 |
67 |
*0 |
*0 |
0 |
0 |
0 |
0 |
*0 |
*0 |
68 |
*0 |
*0 |
0 |
0 |
0 |
0 |
*0 |
*0 |
69 |
*0 |
*0 |
0 |
0 |
0 |
0 |
0 |
0 |
70 |
*0 |
*0 |
0 |
0 |
0 |
0 |
** |
** |
71 |
*0 |
*0 |
*0 |
*0 |
*0 |
*0 |
*0 |
*0 |
72 |
*0 |
*0 |
0 |
0 |
0 |
0 |
*0 |
*0 |
73 |
*0 |
*0 |
0 |
0 |
0 |
0 |
0 |
0 |
74 |
*0 |
*0 |
0 |
0 |
0 |
0 |
*0 |
*0 |
75 |
*0 |
*0 |
*0 |
*0 |
*0 |
*0 |
*0 |
*0 |
76 |
*0 |
*0 |
0 |
*0 |
0 |
*0 |
*0 |
*0 |
77 |
*0 |
*0 |
0 |
0 |
0 |
0 |
*0 |
*0 |
78 |
** |
** |
*0 |
*0 |
0 |
0 |
** |
** |
79 |
*0 |
*0 |
0 |
0 |
*0 |
*0 |
*0 |
*0 |
80 |
*0 |
*0 |
0 |
0 |
*0 |
*0 |
*0 |
*0 |
**=test sample stained the skin and obscured the application site
*0= no reaction, test sample stained the skin but all responses could be assessed
Animal Number |
Control Animals |
|||||||
75% w/v |
30% w/v |
10% w/v |
3% w/v |
|||||
24h |
48h |
24h |
48h |
24h |
48h |
24h |
48h |
|
81 |
*0 |
*0 |
*0 |
*0 |
0 |
0 |
0 |
0 |
82 |
*0 |
*0 |
0 |
0 |
0 |
0 |
0 |
0 |
83 |
*0 |
*0 |
0 |
0 |
*0 |
*0 |
** |
** |
84 |
*0 |
*0 |
0 |
0 |
0 |
0 |
0 |
0 |
85 |
*0 |
*0 |
*0 |
*0 |
0 |
0 |
0 |
0 |
86 |
*0 |
*0 |
0 |
0 |
0 |
0 |
0 |
0 |
87 |
*0 |
*0 |
*0 |
0 |
0 |
0 |
0 |
0 |
88 |
*0 |
*0 |
*0 |
*0 |
*0 |
*0 |
*0 |
*0 |
89 |
*0 |
*0 |
0 |
0 |
0 |
0 |
0 |
0 |
4584 |
*0 |
*0 |
*0 |
*0 |
*0 |
*0 |
** |
*0 |
**=test sample stained the skin and obscured the application site
*0= no reaction, test sample stained the skin but all responses could be assessed
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The sensitisatlon potential of Substance H112339 was assessed using a method based on that described by Buehler (1965).
Challenge of previously induced guinea pigs with either a 75%, 30-%, 10% or a 33; w/v preparation of the test sample in deionised water did not elicit a sensitisation response.
In conclusion. Substance H112339 was not a sensitiser under the conditions of the test. - Executive summary:
Study conducted in compliance with GLP. No EU test standard is referenced within the study report, however the study was conducted to the Buehler method and is considered
The substance is not sensitising under the test conditions.
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.