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EC number: 217-615-7 | CAS number: 1910-42-5
- 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 substance is not considered to be sensitising to the skin, based on the GLP compliant study similar to OECD TG 406.
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:
- May 1994 to Jul 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The sensitisation of the test sample was assessed using a method based on the maximisation test of Magnusson and Kligman (1970).
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
- Species:
- guinea pig
- Strain:
- other: Albino guinea pigs (Hsd/Poc:DH)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adults
- Weight at study initiation: 411 to 537 g
- Housing: individually in suspended stainless steel cages (32.5cm length x 37.5cm width x 23cm height), with solid sheet sides and wire mesh floor and front. The rear was made of vented sheet
- Diet: ad libitum , RGP Diet
- Water: ad libitum
- Acclimation period: 6 days prior to each study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): approximately 25 to 30
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 10 %w/v
30 %w/v - Day(s)/duration:
- 24 h and 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 10 %w/v
- Day(s)/duration:
- 24 h and 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 30 %w/v test group
10 %w/v control group - Day(s)/duration:
- 24 h and 48h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- - 20 test group and positive control group
- 10 negative control group - Details on study design:
- RANGE FINDING TESTS:
The objective of the sighting study was to determine suitable levels for use in the main study. Suitable levels were ones which gave an acceptable degree of irritation and did not give rise to signs of overt systemic toxicity under the conditions of the test. On the basis of skin irritation and systemic toxicity observed in the sighting study, main study dose-levels were selected as described in the main study.
MAIN STUDY
INDUCTION EXPOSURE
Induction A: intradermal, test group: Induction of the test animals was performed by removing the hair with a pair of veterinary clippers from an area approximately 5cm x 5cm on the scapular region of each animal. Subsequently, a row of three injections (0.05-0.1 mL each) was made on each side of the mid-line. The injections were:
- Top: Freund’s Complete Adjuvant plus deionised water in the ratio 1:1;
- Middle: a 0.03% w/v preparation of the test sample in deionised water (the highest concentration which could be tolerated without causing necrosis of the skin at the injection sites);
- Bottom: a 0.03% w/v preparation of the test sample in a 1:1 preparation of Freund's Complete Adjuvant plus deionised water.
Induction A: intradermal, control group: intradermal injections were administered using an identical procedure to that used for the test animals, except that the injections were:
- Top: Freund's Complete Adjuvant plus deionised water in the ratio 1:1;
- Middle: deionised water;
- Bottom: Freund's Complete Adjuvant plus deionised water in the ratio 1:1.
Induction B: epicutaneous, test group: One week later, the scapular area was clipped again and treated with a topical application of the test sample as a 10% w/v preparation (the highest concentration which could be applied topically over the intradermal injection sites without causing signs of toxicity) in deionised water. This preparation (0.2-0.3mL) was applied on filter paper (approximate size 4cm x 2cm) which was held in place by a piece of surgica1 tape. The tape was covered by a strip of adhesive bandage (approximate size 20-30cm x 5cm) and secured by a piece of self-adhesive PVC tape. This occlusive dressing was kept in place for approximately 48 hours. The application sites were checked approximately 24 hours after removal of the dressings.
Induction B: epicutaneous, control group: The topical applications followed the same procedure as for the test animals except that deionised water only was applied to the filter paper.
CHALLENGE EXPOSURE
Two weeks after the topical inductions, an area, approximately 15cm x 5cm, on both flanks of all the test and control animals, was clipped free of hair with a pair of veterinary clippers. An occlusive dressing was prepared which consisted of two pieces of filter paper (approximate size 1cm x 1.5-2.0cm) stitched to a piece of rubber sheeting (approximate size 12cm x 5cm). A 30% w/v preparation (the highest concentration which could be applied without causing skin irritation) of the test sample in deionised water (0.05-0.1 mL) was applied to one of the pieces of filter paper and a 10% w/v preparation in deionised water (0.05-0.1 mL) was applied to the second piece of filter paper. The dressing was placed on to the guinea pig so that the 30% w/v preparation was on the left shorn flank and the 10% w/v preparation was on the right shorn flank. It was then covered with a strip of adhesive bandage (approximate size 25-40cm x 7.5cm) which was secured by a self-adhesive PVC tape. After approximately 24 hours, the dressings were carefully cut, using blunt-tipped scissors, removed and discarded. The position of the pieces of filter paper on the skin were identified using a black waterproof marker pen. The application sites were cleansed free of any residual test sample using clean swabs of absorbent cotton wool soaked in clean arm water and was then dried gently with clean tissue paper. Erythematous reactions were quantified and recorded using the four-point scale (shown in Table 1 in “Any other information on materials and methods incl. tables”) approximately 24 and 48 hours after removal of the dressings. Where necessary animals were re-clipped prior to the 1 day reading.
SCORING
To classify the sensitisation repsonse, the percentage of the control animsl that responded was substracted form the percentage of the test animals that responded. This responsed was compared with the scheme presented in Table 2 in "Any other informaiton on materials and methods incl tables".
POSITIVE CONTROL STUDY
The sensitising potential of 2-mercaptobenzothiazole was assessed at the following concentrations:
- 3% w/v preparation in corn oil was used for the intradermal injections
- 75% w/v preparation in corn oil was applied for the topical induction
- 30% w/v preparation in corn oil was applied for the challenge phase - Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
- Positive control results:
- Following challenge with a 30% w/v preparation of 2-mercaptobenzothiazole, scattered mild redness or moderate and diffuse redness was observed in nineteen test animals. There was no erythematous response in any of the control animals. The net percentage response was calculated to be 95%.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %(w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 %w/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30 %w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 30 %w/v
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 30 %w/v
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study performed similarly to OECD 406, the test substance was not considered to be sensitising to the skin.
- Executive summary:
In this GLP compliant study the sensitisation potential of the test substance was assessed using a method based on the maximisation test of Magnusson and Kligman (1970). Challenge of previously induced guinea pigs with 30% or 10% w/v preparations of the test sample in deionised water did not elicit a skin sensitisation response. In a positive control study, challenge of previously induced guinea pigs with a 30% w/v preparation of 2-mercaptobenzothiazole elicited an extreme skin sensitisation response. In conclusion, the test substance was not a skin sensitiser under the conditions of the test.
Reference
One test animal was found dead following the topical induction. The reason for the death is not known but in the absence of any signs of toxicity in any of the animals it is considered to be unrelated to treatment.
Following challenge with a 30% or a 10% w/v preparation of the test sample in deionised water, there was no erythematous reaction in any of the test or control animals. Initial and final bodyweights indicated that all of the animals exhibited normal growth during the study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a GLP compliant study (Duerden, 1994) the sensitisation potential of the test substance was assessed using a method based on the maximisation test of Magnusson and Kligman (1970). Challenge of previously induced guinea pigs with 30% or 10% w/v preparations of the test sample in deionised water did not elicit a skin sensitisation response. In a positive control study, challenge of previously induced guinea pigs with a 30% w/v preparation of 2-mercaptobenzothiazole elicited an extreme skin sensitisation response. In conclusion, the test substance was not a skin sensitiser under the conditions of the test.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information, classification for skin sensitisation is not warranted in according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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