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EC number: 458-430-3 | CAS number: -
- 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:
- 1999-01-04 to 1999-02-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
Test material
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 354 - 457 g
- Housing: housed singly or in pairs in solid-floor polypropylene cages
- Diet: guinea-pig FD1 diet, ad libitum
- Water: mains tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 40 - 55 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- TEST GROUP
Intradermal induction: 25% w/v in arachis oil BP
Topical induction: undiluted as supplied
Topical challenge: undiluted as supplied and 75% v/v in archis oil BP
NEGATIVE CONTROL:
Intradermal induction: Freund's Complete Adjuvant/distilled water 1:1; arachis oil BP; 50 % arachis oil BP in Freund's Complete Adjuvant/distilled water 1:1
Topical induction: blank patch applied
Topical challenge: 75% and 100% in arachis oil BP
POSITIVE CONTROL:
Intradermal induction: 10 % 2-mercaptobenzothiazole in arachis oil BP
Topical induction: 50 % in acetone PEG 400 (70:30)
Topical challenge: 25 % and 50 % in acetone PEG 400 (70:30)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- TEST GROUP
Intradermal induction: 25% w/v in arachis oil BP
Topical induction: undiluted as supplied
Topical challenge: undiluted as supplied and 75% v/v in archis oil BP
NEGATIVE CONTROL:
Intradermal induction: Freund's Complete Adjuvant/distilled water 1:1; arachis oil BP; 50 % arachis oil BP in Freund's Complete Adjuvant/distilled water 1:1
Topical induction: blank patch applied
Topical challenge: 75% and 100% in arachis oil BP
POSITIVE CONTROL:
Intradermal induction: 10 % 2-mercaptobenzothiazole in arachis oil BP
Topical induction: 50 % in acetone PEG 400 (70:30)
Topical challenge: 25 % and 50 % in acetone PEG 400 (70:30)
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- RANGE FINDING TESTS:
Selection of concentrations for intradermal injection: Solution of 1 %, 5 %, 10 % and 25 % (v/v) of test material in arachis oil BP was injected to 4 guinea-pigs. Each animal received four 0.1 ml injections of only one concentration. The degree of erythema was assessed at 24 h, 48 h, 72 h and 7 days. The degree of oedema was not assessed. The highest concentration that caused mild to moderate skin irritation and that was well-tolerated systematically was selected for the intradermal injection stage. Mild to moderate erythema was observed in all the animals at 24, 48, 72 hours and 7 days post-treatment. The selected concentration for intradermal injection was 25 % (w/v) in arachis oil BP.
Selection of concentration for topical induction: Two guinea-pigs were injected with Freund's Complete Adjuvant 16 days earlier. They were treated with undiluted test material as well as solutions of 25 %, 50 % and 75 % (v/v) of the test material in arachis oil BP. The test material was applied for 48 h under occlusive dressing and the degree of erythema and oedema was evaluated at 1 h, 24 h, 48 h after dressing removal. The highest concentration producing mild to moderate irritation reaction was selected for the topical induction stage. The results showed that the test material was not irritating and undiluted test material was selected for the topical induction stage of the main study.
Selection of concentration for topical challenge: The test material was applied undiluted and in solutions of 25 %, 50 % and 75 % in arachis oil BP to clipped skin of two guinea-pigs for 24 h under occlusive dressing. The degree of erythema and oedema was evaluated at 1 h, 24 h and 48 h after dressing removal. The highest non-irritant concentration and one lower were selected for the topical challenge stage. Slight erythema was observed at 1 hour post-treatment. There were no other clinical changes at 1, 24 and 48 hours observations. Undiluted test material and 75 % (v/v) in arachis oil BP were the selected concentrations for the challenge stage of the main study.
MAIN STUDY
A test group of 10 guinea-pigs and a control group of 5 guinea-pigs were used in the study. The body weight of each animal was recorded at the start and the end of the study.
A. INDUCTION EXPOSURE
Test group: The shoulder region of all the test animals was clipped and 3 injections (0.1 ml) were administered on each side of the mid-line. Injection 1 - Freund's Complete Adjuvant plus distilled water in the ratio 1:1; injection 2 - 25 % (w/v) of the test material in arachis oil BP, injection 3 - 25 % (w/v) of the test material in 1:1 preparation of Freund's Complete Adjuvant plus distilled water. The degree of erythema was evaluated at 24 h and 48 h post-injection using Draize score system. On day 7 of the study period, the same area was clipped and shaved. The undiluted test material was applied to the test area and kept under occlusive dressing for 48 hours. The degree of erythema and oedema was evaluated at 1 and 24 hours after removal of the dressing. Other reactions were also recorded.
Control group: Three intradermal injections were administered to the control animals. Injection 1 - Freund's Comlete Adjuvant plus distilled water in ration 1:1. Injection 2 - arachis oil BP. Injection 3 - 50 % solution of arachis oil BP in Freund's Complete Adjuvant plus distilled water in ration 1:1. The degree of erythema and oedema was evaluated according to Draize score at 24 and 48 hours post-injections. The test material was kept for 48 hours under an occlusive dressing.
B. CHALLENGE EXPOSURE
Test and control group: On day 21 the right and left shorn flank of each animal were clipped and shaved. The unsaturated test material was applied onto the right shorn flank under an occlusive dressing for 24 hours. A solution of 75 % (v/v) test material in arachis oil BP was applied to the left shorn flank under occlusive dressing, kept for 24 hours. After removal of both patches, the test sites were swabbed with diethyl ether to remove residual material. The degree of erythema and oedema was evaluated using Draize scale at 24 and 48 hours after removal of the dressing. - Challenge controls:
- A 75% and 100% application of test material on control animals, resulted in no erythema or oedema and no other reactions were noted.
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
Results and discussion
- Positive control results:
- The historical positive control data records show appropriate positive control reactions, ranging from 70-100% of the test animals being sensitised.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Key result
- Reading:
- other: Historical positive control data
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Historical positive control data were reported in Appendix XI of the study report. Appropriate incidence of sensitisation was reported for 2-mercaptobenzothiazole and 2,4,-dinitrochlorobenzene.
Any other information on results incl. tables
Signs of irritation during induction:
Skin Reactions Observed After Intradermal Induction:
Test group: Well-defined moderate to severe erythema was noted at the
intradermal induction sites of all test group animals at
the 24-hour observation with very slight to moderate to
severe erythema at the 48-hour observation.
Control group: Very slight to well-defined erythema was noted at the
intradermal induction sites of all control group animals at
the 24-hour observation with very slight erythema at the 48-hour observation.
Skin Reactions Observed After Topical Induction:
Test group: Hardened, adhered test material, which precluded the accurate evaluation of erythema, was noted at the topical induction sites of four test group animals with residual test material at the topical induction sites of three other test group animals at the 1-hour observation. Slight yellow-coloured staining was noted at the topical induction sites of three test group animals at the 24-hour observation.
Very slight to well-defined erythema was noted at the
topical induction sites of six test group animals at the 1-hour observation. Very slight to slight oedema was noted at
the topical induction sites of all test group animals at the
1-hour observation. Very slight erythema with or without
very slight oedema was noted at the topical induction sites
of nine test group animals at the 24-hour observation.
Other skin reactions noted at the topical induction sites of
test group animals at the 1-hour observation were
desquamation and bleeding from the intradermal injection
sites of the two test group animals at the 24-hour observation.
Control group: Very slight to well-defined erythema with or without very
slight oedema was noted at the topical induction sites of
all control group animals at the 1-hour observation. Very
slight erythema was noted at the topical induction sites of
four control group animals at the 24-hour observation.
Other skin reactions noted at the topical induction sites of
control group animals at the 1-hour observation were
desquamation and bleeding from the intradermal injection
sites. Dried blood was noted at the intradermal injection
sites of two control group animals at the 24-hour observation.
Evidence of sensitisation of each challenge concentration:
Number of animals showing evidence of sensitisation at each
challenge concentration: 0/10
Gain in body weight was observed in both the test and control groups.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was found not to be sensitising to skin, in Guinea Pig Maximisation Test, conducted according to OECD TG 406 and in compliance with GLP.
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