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EC number: 251-752-3 | CAS number: 33941-99-0
- 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
Skin sensitisation (OECD 406): not sensisiting
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 Dec 1999 - 04 Feb 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 Jul 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was done before LLNA as first-choice method for in-vivo testing was set into force.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 8-12 weeks
- Weight at study initiation: 344-388 g
- Housing: animals were housed singly or in pairs in solid-floor polypropylene cages, bedding woodflakes
- Diet: Guinea Pig FD1 Diet (Special Diets Services LTD, Witham, UK), ad libitum
- Water: mains tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 1%
- Day(s)/duration:
- single injection
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 75%
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- other: non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 (controls), 10 (test group)
- Details on study design:
- RANGE FINDING TESTS:
A range finding study was performed to determine the appropriate dose level of the test substance following intradermal and epicutaneous administrations. For the selection of the intradermal induction concentration test substance concentrations of 1 and 5% were investigated. A total of two animals were used, each animal receiving four injections of only one concentration of test substance. Moderate and confluent erythema (score 2) was observed 24 and 48 h and discrete or patchy erythema (score 1) was observed 72 h after treatment with 1% test substance concentration. Moderate and confluent erythema to intense erythema and swelling (score 2-3) was observed after 24 and 48 h and discrete or patchy erythema (score 1) was observed 72 h after treatment with 5% test substance concentration. The effects were fully reversible within 7 days. No evidence of systemic toxicity was observed. The concentration selected for the intradermal induction stage of the main study was 1%.
For the selection of the topical induction concentration two animals (intradermally injected with FCA nine days earlier) were treated 48 h with undiluted test substance and three preparations of the test substance (25, 50 and 75%). Moderate and confluent erythema (score 2) was observed 1 h after patch removal in two animals at 75 and 100%. Discrete or patchy erythema (score 1) was observed only in one animal 1 h after patch removal at 50%. Discrete or patchy erythema (score 1) was observed at 75 and 100% in one animal and at 50, 75 and 100% in the second animal 24 h after patch removal. Only discrete or patchy erythema (score 1) was observed in one animal 48 h after patch removal at 100%. No oedema was observed up to the highest concentration tested. The undiluted test substance was selected for the main study topical induction.
For the selection of the topical challenge concentration two animals (identically treated to the control animals of the main study up to Day 14) were treated with undiluted test substance and three preparations of the test substance (25, 50 and 75) under occlusive conditions for 24 h. Only discrete or patchy erythema (score 1) was observed 1 h after removal of the dressing at 100% in two animals. No oedema was observed up to the highest concentration tested. The concentrations selected for the main study topical challenge were 75 and 100%.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture FCA/water
Injection 2: 1% test substance in arachis oil
Injection 3: equal amounts of 1% test substance and FCA
Epicutaneous: undiluted test substance
- Control group:
Injection 1: a 1:1 mixture FCA/water
Injection 2: arachis oil
Injection 3: equal amounts of 50% arachis oil and FCA
Epicutaneous: black filter paper
- Site: shoulder region (intradermal + epicutaneous)
- Duration: Days 0-7
- Concentrations: intradermal 1%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (challenge)
- Day of challenge: 21 (challenge)
- Exposure period: 24 h
- Test groups: undiluted test substance and 75% test substance in arachis oil
- Control group: undiluted test substance and 75% test substance in arachis oil
- Site: right flank (100% test substance) and left flank (75% test substance)
- Concentrations: 75 and 100%
- Evaluation: 24 and 48 h after patch removal - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole, Induction: intradermal 5% in arachis oil, epicutaneous 50% in acetone:PEG 400 (70:30), Challenge: 25 and 50% in acetone:PEG 400 (70:30)
- Positive control results:
- The positive control substance induced positive reactions in 10/10 animals (100%). The positive control group was not carried out concurrently with this study but is a historical background data group from a study performed during 12 Jan and 05 Feb 2000.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction intradermal: 0%; challenge: 75%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- One animal was found dead on Day 20.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction intradermal: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- One animal was found dead on Day 20.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction intradermal: 1%; challenge: 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction intradermal: 1%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction intradermal: 0%; challenge: 75%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- One animal was found dead on Day 20.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction intradermal: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- One animal was found dead on Day 20.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction intradermal: 1%; challenge: 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction intradermal: 1%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50% in acetone:PEG 400 (70:30), Challenge: 25 and 50% in acetone:PEG 400 (70:30)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- none
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of the guinea pig maximisation test the test substance revealed no sensitising properties.
- Executive summary:
Ten test and five control animals were used for the main study. Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as follows: Intradermal Induction 1% v/v in arachis oil BP; Topical Induction undiluted as supplied; Topical Challenge undiluted as supplied and 75% v/v in arachis oil BP. The test material produced a 0% (0/10) sensitisation rate.
Reference
Discrete or patchy to moderate and confluent erythema was noted at the intradermal induction sites of all test group animals after 24 h and with discrete or patchy to intense erythema and swelling after 48 h.
Discrete or patchy erythema was noted at the intradermal induction sites of all control group animals after 24 h and in two control group animals after 48 h.
Discrete or patchy erythema was noted at the induction sites of seven test group animals after 1 h and in four test group animals after 24 h. Bleeding from the intradermal injection sites was noted in four test group animals after 1h.
Bleeding from the intradermal injection sites was noted in four control group animals after 1h. No signs of erythema or oedema were noted at the treatment sites of control group animals after 24 h.
No skin reactions were noted at the challenge sites of the test or control group animals after 24 and 48 h.
Body weight gains of animals in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period.
One control group animal was found dead on Day 20. The cause of death was not determined but was thought not to be treatment-related. The absence of this animal was considered not to affect the purpose or integrity of the study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitising potential of the test substance was investigated in a guinea pig maximisation test (GPMT) performed according to OECD Guideline 406 and in compliance with GLP (2000). In this study the test substance did not reveal sensitising properties.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on sensitisation do not meet the criteria for classification according to Regulation (EC) 1272/2008
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.
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