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EC number: 608-605-7 | CAS number: 313482-99-4
- 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: not sensitising (OECD 406; GLP)
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:
- 2002-12-09 to 2003-04-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Deviations from the OECD guideline 406 (1992): positive control (i.e., alpha-hexylcinnamicaldehyde) was evaluated after 24 hours as being sensitising (5/10 animals; 20 %), after 48 hours 2/10 animals showed a skin reaction; semi-occlusive dressing was used instead of occlusive dressing; during the induction phase; concentrations of the intradermal injections 2 and 3 shall be the same, but in this study injection 2 was 5 % of the test item and injection 3 was 10 % of the test item; a modified Magnusson and Kligman grading scale was used.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992-07-17
- Deviations:
- yes
- Remarks:
- please refer to the field "Rationale for reliablity incl. deficiencies" above
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- According to the REACH regluation (EC) No. 1907/2006, the LLNA test is the first-choice method for in vivo testing and in exceptional circumstances another test can be used. Since the study was carried out before the regulation entered into force and the guinea pig maximisation test according to OECD 406 is an acceptable method for testing skin sensitisation, it is not justified to conducted an LLNA test due to animal welfare in addition.
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the freezer protected from light, under nitrogen - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 4 weeks old
- Weight at study initiation: test animals: 311 to 367 g; control animals: 326 - 358 g
- Housing: group hosuing of maximally 5 animals/cage (74 cm x 54 cm x 25 cm height); bedding material: purified sawdust (SAWI, Jelu Werk, Rosenberg, Germany)
- Diet (ad libitum): standard guinea pig diet, including ascorbic acid (1000 mg/kg)(Charles River Breeding and Maintenance Diet for Guinea Pigs, Altromin, Lage; Germany); Pressed hay (B.M.I., Helmond, The Netherlands) was provided twice a week.
- Water (ad libitum): tap water (200 mg/L vitamin C was added to the water )
- Acclimation period: at least 5 days before the start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3 °C
- Relative humidity: 30 - 70 %
- Air changes: approx. 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Concentration / amount:
- 1:1 w/w mixture of Freunds' complete adjuvant with water for injection
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 5 % test item
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 1:1 w/w mixture of 10 % of the test item and Freunds' Complete Adjuvant
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- corn oil
- Concentration / amount:
- 20 % test item
- Day(s)/duration:
- Day 7
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- corn oil
- Concentration / amount:
- 20 % test item
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 (test substance) + 5 (controls)
- Details on study design:
- RANGE FINDING TESTS:
a) Interdermal injections:
A series of four test substance concentrations (2, 5, 10 and 20* %) was used, the highest concentration being the maximum concentration that could technically be injected. Each of two animals received two differen concentrations in duplicate (0.1 mL/site) in the clipped scapular region. The injection sites were assessed for irritation 24 and 48 hours after treatment.
b) Epidermal application:
A series of four test substance concentrations (2, 5, 10, 20* %) was used, the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 mL each) per animal to the clipped flank, using Metalline patches (2 x 3 cm) mounted on Medical tape which were held in place with Micropore tape and subsequently Coban elastic bandage. The animals receiving intradermal injections were treated with the lowest concentrations and two further animals with the highest concentrations.
After 24 hours, the dressing was removed and the skin cleaned of residual test substance using water.
The treated skin areas were assessed for irritation 24 and 48 hours after exposure.
Results:
Based on the results, the test substance concentrations selected tor the main study were a 5% concentration for the intradermal induction and a 20% concentration for the epidermal inductionexposure.
No signs of irritation were observed to the highest test substance concentration epidermally tested. Therefore, the test site of all animals was treated with 10% SDS approximately 24 hours before the epidermal induction in the main study, to provoke a mild inflammatory reaction.
A 20% test substance concentration was selected for the challenge phase.
*Trail formulations showed that a 20 % concentration was the highest concentration that could be prepared homogeneously to visually accpetable levels.
Injection of a 20 % concentration was difficult and the reliability of the injected volume could not be esablished. A 10 % test substance concentration was considered the highest concentration that could reproducibly be injected.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal injection and dermal application)
- Site: the scapular region was clipped and three pairs of intradermal injections (0.1 mL/site) were made in this area on day 1. On day 3, the dermal reactions caused by the intradermal injections were assessed for irritation. Then, the scapular area between the injection sites was clipped and subsequently rubbed with 10 % sodium-dodecyl-sulfate (SDS) in vaseline using a spatula on day 7. On day 8, the 10 % SDS treated area between the injection sites was treated with 0.5 mL of a 20 % test substance concentration using a Metalline patch (2 x 3cm) mounted on Medical tape, which was held in place with Micropore tape and subsequently Coban elastic bandage.
The dressing was removed after 48 hours exposure, the skin cleaned of residual test substance using water and the dermal rections caused by the epidermal exposure were assessed for irritation.
- Concentrations:
Test animals:
Intradermal:
i) 1:1 w/w mixture of Freunds' Complete Adjuvant with water for injection
ii) the test substance in corn oil at a 5 % concentration
iii) a 1:1 w/w mixture of the test substance, at twice the concentration used in (ii) and Freunds' Complete adjuvant.
Control animals:
Intradermal injection:
i) 1:1 w/w mixture of Freunds' Complete Adjuvant with water for injection
ii) 0.1 mL corn oil
iii) a 1:1 w/w mixture of corn oil and Freunds' Complete adjuvant.
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (two weeks after the topical application (induction))
- Exposure period: 24 hours
- Site (test animals and controls): one flank of all animals was clipped and treated by epidermal application of a 20% test substance concentration and the vehicle (0.1 mL each)
- Evaluation (hr after challenge): 24 and 48 hours
OTHER OBSERVATIONS:
- Mortality/Viability: twice daily
- Toxicity: at least once daily
- body weights: prior to start and at termination of the study
- skin reactions: skin reactions were graded according to the Draize scale, Furthermore, a description of all other (local) effects was recorded. Whenever necessary, the treated skin-areas were clipped at least 3 hours before the next skin reading to facilitate scoring. - Challenge controls:
- 5 guinea pigs were used as control animals.
Challenge dose: one flank of all animals was clipped and treated by epidermal application of a 20% test substance concentration and the vehicle (0.1 mL each) - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamicaldehyde, tech. 85 % (study conducted not more than 6 months prior to current study; 10 test & 5 control animals; intradermal (induction): 20 % sol. in H2O (w/w); topical (induction): undiluted; challenge: 20 % sol. in H2O (w/w))
- Positive control results:
- The skin reactions (grade 1 to 2; 24 hour reading) observed in five experimental animals in response to the 20 % test substance concentration in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals. These results lead to a sensitisation rate of 50 % to the 20 % concentration.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 % test item
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reactions were evident after the challenge exposure. No mortality occurred & no clinical signs were observed in the animals of the main study. Body weights & body weight gain of experimental animals remained in the same range as controls.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 % test item
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reactions were evident after the challenge exposure. No mortality occurred & no clinical signs were observed in the animals of the main study. Body weights & body weight gain of experimental animals remained in the same range as controls.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20 % test item
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20 % test item
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 20 % positive control
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 20 % positive control
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Some animals showed scaliness.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the Regulation (EC) 1272/2008 and subsequent adaptations, the substance is not sensitising to the skin.
Reference
MAIN STUDY -INDUCTION
The reactions noted in the experimental and control animals after the epidermal induction exposure were considered to be enhanced by the SDS treatment.
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
Skin sensitisation
The substance does not possess a skin sensitisation potential and does not require classification as skin sensitiser according to Regulation (EC) No 1272/2008 and subsequent adaptations.
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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