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EC number: 278-188-0 | CAS number: 75314-26-0
- 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
The test material produced a 0% (0/10) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to the regulation 1272/2008/EC after reinterpretation of the raw data.
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:
- 09 November 1998 - 21 December 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study following test guideline OECD406. The study can be used to draw a conclusion on the non sensitizing properties to skin of the tested substance, which differs slightly from the registered substance. The report does not include the compostion of the test substance.
- 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:
- The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing according to the REACH Regulation. However, this reliable GPMT test was performed before entry into force of the REACH Regulation.
- Specific details on test material used for the study:
- Date received : 02 November 1998
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Albino animals
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: eight to twelve weeks old
- Weight at study initiation: 311 to 357g
- Housing: singly or in pairs in solid-floor polypropylene cages furnished with woodflakes.
- Diet: Guinea Pig FD1 Diet, Special Diets Services Limited, Witham, Essex, UK ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 22°C
- Humidity (%): 44 to 51%
- Air changes (per hr): Approx. 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 1% w/v
- 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:
- Filter paper patch WHATMAN No.4 approximate size 20 mm x 20 mm, saturated with the undiluted test material
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Filter paper patch WHATMAN No.4, approximate size 20 mm x 20 mm, saturated with the undiluted test material and 75% v/v in distilled water
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 test animals, 5 control animals
- Details on study design:
- RANGE FINDING TESTS:
1 - Selection of Concentration for lntradermal lnduction
Two concentrations of test material were investigated (5% and 1% w/v in distilled water). A total of two guinea pigs were used, each guinea pig receiving four 0.1 ml injections of only one concentration of test material. The degree of erythema at the injection sites was assessed approximately 24,48 and 72 hours and 7 days after injection according to the Draize scale. The degree of oedema was not evaluated. Any evidence of systemic toxicity was also recorded. The highest concentration that caused only mild to moderate skin irritation, and which was well tolerated systemically, was selected for the intradermal induction stage of the main study.
2 - Selection of Concentration for Topical lnduction
Two guinea pigs (intradermally injected with Freund's Complete Adjuvant eleven days earlier) were treated with the undiluted test material and three preparations of the test material (75%, 50% and 25% vlv in distilled water). Applications were made to the clipped flanks under occlusive dressings for an exposure period of 48 hours. The degree of erythema and oedema was evaluated approximately 1, 24 and 48 hours after dressing removal. The highest concentration producing only mild to moderate dermal irritation was selected for the topical induction stage of the main study.
3 - Selection of Concentration for Topical Challenge
The undiluted test material and three preparations of the test material (75%,50% and 25% v/v in distilled water) were applied to the clipped flanks of two guinea pigs under occlusive dressings for an exposure period of 24 hours. These guinea pigs did not form part of the main study but had been treated identically to the control animals of the main study, up to Day 14. The degree of erythema and oedema was evaluated approximately 1 , 24 and 48 hours after
dressing removal. The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge stage of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
lnduction of the Test Animals: Shortly before treatment on Day 0 the hair was removed from an area approximately 40 mm x 60 mm on the shoulder region of each animal with veterinary clippers. A row of three injections (0.1 ml each) was made on each side of the mid line. The injections were:
a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) a 1% w/v formulation of the test material in distilled water
c) a 1% w/v formulation of the test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
Approximately 24 and 48 hours after intradermal injection the degree of erythema at the test material injection sites (ie. injection site b) was evaluated
One week later (Day 7),the same area on the shoulder region used previously for intradermal injections was clipped again and treated with a topical application of the undiluted test material. A filter paper patch (WHATMAN No.4: approximate size 40 mm x 20 mm), saturated with the undiluted test material was applied to the prepared skin and held in place with a strip of surgical adhesive tape (BLENDERM: approximate size 50 mm x 30 mm) covered with an overlapping length of aluminium foil. The patch and foil were further secured with a strip of elastic adhesive bandage (ELASTOPLAST: approximate size 250 mm x 35 mm) wound in a double layer around the torso of each animal. This occlusive dressing was kept in place for 48 hours.
The degree of erythema and oedema was quantified one and twenty four hours following removal of the patches
lnduction of the Control Animals: lntradermal injections were administered using an identical procedure to that used for the test animals, except that the injections were:
a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) distilled water
c) a 50% w/v formulation of distilled water in Freund's Complete Adjuvant/distilled water 1 : 1
Approximalely 24 and 48 hours after intradermal injection the degree of efihema at the vehicle injection sites (ie injection site b) was evaluated.
The topical applications followed the same procedure as for the test animals except that nothing was applied to the filter paper. Skin reactions were quantified as for the test animals.
B. CHALLENGE EXPOSURE
Shortly before treatment on Day 21, an area of approximately 50 mm x 70 mm on both flanks of each animal, was clipped free of hair with veterinary clippers.
A square filter paper patch (WHATMAN No.4: approximate size 20 mm x 20 mm), saturated with the undiluted test material was applied to the shorn right flank of each animal and was held in place with a strip of surgical adhesive tape (BLENDERM: approximate size 40 mm x 50 mm). To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 75% v/v in distilled water was similarly applied to a skin site on the left shorn flank. The patches were occluded with an overlapping length of aluminium foil and secured with a strip of elastic adhesive bandage (ELASTOPLAST: approximate size 250 mm x 75 mm) wound in a double layer around the torso of each animal.
After 24 hours, the dressing was carefully cut using blunt-tipped scissors, removed and discarded. The challenge sites were swabbed with cotton wool soaked in distilled water to remove residual material. The position of the treatment sites was identified by using a black indelible marker-pen.
Prior to the 24-hour observation the flanks were clipped using veterinary clippers to remove regrown hair.
- Challenge controls:
- Approximately 24 and 48 hours after challenge dressing removal, the degree of erythema and oedema was quantified
- Positive control substance(s):
- no
- 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
- Remarks on result:
- no indication of skin sensitisation
- 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
- Remarks on result:
- no indication of skin sensitisation
- 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
- Remarks on result:
- no indication of skin sensitisation
- 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
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: project no. 039/163
- Group:
- positive control
- Dose level:
- 10% of 2-Mercaptobenzothiazole in arachis oil BP (intradermal) / 50% of 2-Mercaptobenzothiazole in acetone:PEG400 70:30 (topical) / 50% and 25% of 2-Mercaptobenzothiazole in acetone:PEG400 70:30 (challenge)
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- other: report no. 039/239
- Group:
- positive control
- Dose level:
- 10% of 2-Mercaptobenzothiazole in arachis oil BP (intradermal) / 50% of 2-Mercaptobenzothiazole in acetone:PEG400 70:30 (topical) / 50% and 25% of 2-Mercaptobenzothiazole in acetone:PEG400 70:30 (challenge)
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- other: report no. 039/249
- Group:
- positive control
- Dose level:
- 10% of 2-Mercaptobenzothiazole in arachis oil BP (intradermal) / 50% of 2-Mercaptobenzothiazole in acetone:PEG400 70:30 (topical) / 50% and 25% of 2-Mercaptobenzothiazole in acetone:PEG400 70:30 (challenge)
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- other: report no. 039/258
- Group:
- positive control
- Dose level:
- 10% of 2-Mercaptobenzothiazole in arachis oil BP (intradermal) / 50% of 2-Mercaptobenzothiazole in acetone:PEG400 70:30 (topical) / 50% and 25% of 2-Mercaptobenzothiazole in acetone:PEG400 70:30 (challenge)
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- other: report no. 039/284
- Group:
- positive control
- Dose level:
- 10% of 2-Mercaptobenzothiazole in arachis oil BP (intradermal) / 50% of 2-Mercaptobenzothiazole in acetone:PEG400 70:30 (topical) / 50% and 25% of 2-Mercaptobenzothiazole in acetone:PEG400 70:30 (challenge)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- other: report no. 413/26
- Group:
- positive control
- Dose level:
- 0.1% of 2,4-Dinitrochlorobenzene in arachis oil BP (intradermal) / 0.75% of 2,4-Dinitrochlorobenzene in 80% aqueus ethanol (topical) / 0.25% and 0.1% of 2,4-Dinitrochlorobenzene in 80% aqueus ethanol (challenge)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material produced a 0% (0/10) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to the regulation 1272/2008/EC after reinterpretation of the raw data.
- Executive summary:
A study was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. The study was performed in compliance with the OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992) and Method 86 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
The results may be used as a basis for classification and labelling under Annex Vl of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 93/21/EEC).
2. 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:
lntradermal lnduction: 1% w/v in distilled water
Topical lnduction: undiluted as supplied
Topical Challenge: undiluted as supplied and 75% v/v in distilled water
3. The test material produced a 0% (0/10) sensitisation rate and was classified as a nonsensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to the regulation 1272/2008/EC after reinterpretation of the raw data.
Reference
Skin Reactions Observed After lntradermal lnduction:
Well-defined or moderate to severe erythema was noted at the intradermal injection sites of test group animals at the 24 and 48-hour observations.
lncidents of very slight erythema were noted at the intradermal injection sites of control group animals.
Skin Reactions Observed After Topical lnduction:
Very slight or well-defined erythema and incidents of very slight or slight oedema were noted at the topical induction sites of all test group animals at the 1-hour observation and eight test group animals at the 24-hour observation.
lncidents of bleeding from the intradermal injection sites were noted in test and control group animals at the 1-hour observation.
No skin reactions were noted at the topical induction sites of control group animals at the 1 and 24-hour observations.
Skin Reactions Observed After Topical Challenge:
Undiluted As Supplied: No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-hour observations.
75% v/v in Distilled Water: No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-hour observations.
Bodyweight:
Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period.
Evidence of Systemic Toxicity:
There was no evidence of systemic toxicity.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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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