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EC number: 800-036-4 | CAS number: 1422423-64-0
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 22nd to August 14th, 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test already available on the target substance. No further tests were conducted.
Test material
- Reference substance name:
- Set Retard Plus
- IUPAC Name:
- Set Retard Plus
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: bred and reared at the Haffkine Biopharmaceuticals, Mumbai.
- Age at study initiation: 11-18 weeks
- Weight at study initiation: 289 to 404 g
- Diet : 'Amrut' brand extruded pelleted Guinea-Pig feed manufactured by Pranav Agro Industries Ltd., Pune, was provided ad libitum. This diet was supplemented by a daily dose of Vitamin C administered as oral drops.
- Water: potable water, passed through Aqua guard water filter, and subjected to ultra violet irradiation, was provided ad libitum in sterilized glass bottles with stainless steel sipper tubes, throughout the acclimation and study period.
- Acclimation period: at least five days under experimental room conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: 10-15 per hrs
- Photoperiod:12 hrs dark/12 hrs light.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Induction 1 - 5 % w/v
- Day(s)/duration:
- day 0
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction 2 - 25 % w/v
- Day(s)/duration:
- day 6
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 % w/v
- Day(s)/duration:
- day 20
- No. of animals per dose:
- Dose range finding test: 8 animals
Definitive study: 30 animals - Details on study design:
- INDUCTION
- Type of induction: intradermal injection and epicutaneous, occlusive.
- No. of exposures: the test animals were initially exposed to the test article by an intradermal injection on day 0, followed by topical application (induction exposures) on day 6.
- Applications: three pairs of intradermal injections of 0.1 ml volume were given in the shoulder region. Topical application was maintained over a period of 48 hours; after contact period the test patch was removed and skin was wiped with physiological saline swab and dried.
- Duration: rest period of 14 days (induction period).
- Preparation of the treated area: approximately 24 hours before treatment, the hair on the shoulders (back) of the guinea pigs was closely clipped with an electric clipper exposing an area of approximately 40 cm2 (6 x 7 cm).
- Intradermal injection area: the intradermal injection area was cleared of hair, so that one of each pair lay on each side of the midline.
- Topical application patch: the test patch, a filter paper (2 cm x 4 cm), was loaded with test article or the vehicle and was applied to the clipped skin area on the back of the animals. The test patch was covered with an aluminum foil and was secured in position with an adhesive tape (Johnsonplast, USP).
CHALLENGE EXPOSURE
- Type challenge: epicutaneous, occlusive.
- Day(s) of challenge: the animals were exposed to a challenge exposure on day 20.
- Applications: topical application was maintained over a period of 24 hours; after contact period the test patch was removed and skin was wiped with physiological saline and dried.
- Preparation of the treated area: the flanks of treated and control animals were cleared of hair approximately 24 hours before treatment. The test patch, a filter paper (2 cm x 4 cm) was loaded with test article (25 % w/v) and was applied to the clipped skin area on the left flank of the animals. The test patch was covered with an aluminum foil and was secured in position with an adhesive tape (Johnsonplast, USP).
RECHALLENGE EXPOSURE
- Type challenge: epicutaneous, occlusive.
- Application: in absence of any ambiguity in the results obtained in the first challenge, a second challenge (i.e. a rechallenge) was not carried out. - Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4 Dinitrochlorobenzene
Results and discussion
- Positive control results:
- A positive response was observed in 60 % of the test animals, classifying the control article as a moderate sensitizer.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no incidence of signs of systemic toxicity in any of the animals throughout the study period.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no incidence of signs of systemic toxicity in any of the animals throughout the study period.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no incidence of signs of systemic toxicity in any of the animals throughout the study period.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no incidence of signs of systemic toxicity in any of the animals throughout the study period.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation
- Conclusions:
- Based upon the findings of this Guinea Pig maximization Test (GPMT), the test article is classified as non-sensitiser to guinea pig as per the Magnusson and Kligman criteria of classification.
- Executive summary:
Method
The assessment of the allergic contact sensitisation potential of the target substance was performed as per the Guinea Pig Maximization Test (GPMT), in compliance with the OECD Guidelines for Testing of Chemicals, Section 4, No. 406 - Skin sensitisation, adopted on 17 July 1992. The Guinea Pig maximization Test (GPMT) of Magnusson and Kligman, which uses Freund’s complete adjuvant (FCA), was employed as recommended by the OECD test guideline.
As an attempt to induce sensitisation, the test animals were initially exposed to 5 % (w/v, aqueous) suspension of test item by intradermal injections made on either side of shoulder (back) area on day 0. This was followed by topical application of a 25 % suspension (w/v, aqueous) on their back on day 6 with an exposure period of 48 h.
Because the test article was not found to be a topical skin irritant in guinea pigs during pilot study, in order to create a local irritation, the test area was painted with 0.5 ml of 10 % sodium lauryl sulphate in vaseline, about 24 hours before the topical induction application.Thereafter, following a rest period of 14 days (induction period), during which an immune response was likely to develop, the animals were exposed to a challenge exposure on day 20 of the study, by topical application of test item (25 % suspension, w/v, aqueous) on their left flank.All topical applications made were occlusive in nature and the periods of exposure were 48 h for induction and 24 h for the purpose of challenge.
Obserations
Skin reaction was recorded at 48 and 72 hours after removal of the inductionpatches, and at 24 and 48 hours after removal of the challenge patches. The extent and degree of skin reaction to the challenge exposure in the test animals was compared with that demonstrated by vehicle control animals which underwent sham treatment during induction and received the challenge exposure. The class of the sensitisation potential of test article was assigned according to the frequency (in percentage) of animals giving a positive response in the test group and graded as per the classification of Magnusson, B. and Kligman, A. (1970). The guinea pigs were examined for survival and abnormal clinical signs daily during the study, and their body weights were recorded at start and termination of the experiment. In this study, all guinea-pigs survived through the duration of the study. Clinical observations made periodically during the study revealed that the test item did not induce any signs of systemic toxicity in the exposed animals. There was no adverse effect of the treatment on the body weight gain by the exposed guinea pigs. As evident at 24 h and 48 h after the intradermal injections made for the purpose of ‘induction’, and as per the requirement of the study protocol, the test article, induced very slight to well defined erythema at the injections sites in the treated guinea pigs. As evident at 24 h and 48 h after the topical induction patch removal, the target substance induced a mild irritation at these skin sites, pre-treated with sodium lauryl sulphate.
Results
Following, challenge application on day 20, there was no evidence of any acute dermal response at the site of application in the form of erythema and/or swelling in all animals from the control and the treatment groups on observation day 22 and 23.In absence of any positive skin response indicative of sensitisation in treated animals following the challenge, the test article, is considered as non-sensitiser to guinea pig.
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