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EC number: 410-690-9 | CAS number: 103055-07-8 CGA 184699
- 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: sensitising, male/female, Guinea pig, OECD TG 406, Schneider 1988.
- Respiratory sensitisation: not expected to be of concern for respiratory sensitisation.
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 May 1988 to 09 Jun 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- May 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1984
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The GPMT test has been carried out as an animal test to predict human sensitisation for over a decade and is recommended by international test guidelines such as the OECD.
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 10 weeks old.
- Weight at study initiation: 340 to 436 g.
- Housing: The animals were housed individually in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the random number generator.
- Diet: standard guinea pig pellets, ad libitum.
- Water: fresh water, ad libitum
- Acclimation period: 1 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 09 May 1988 To: 09 Jun 1988 - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- Injection: 0.1 mL
Treatment: adjuvant/physiological saline mixture, 1:1 (v/v)
Control: adjuvant/physiologicalsaline mixture, 1:1 (v/v) - Day(s)/duration:
- Day 0: First injection out of the three pairs of intradermal injections
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- Injection: 0.1 mL
Treatment: 5.0 % test substance in arachis oil
Control: arachis oil - Day(s)/duration:
- Day 0: Second injection out of the three pairs of intradermal injections
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- Injection: 0.1 mL
Treatment: 5.0 % test substance in adjuvant/physiological saline mixture, 1:1 (v/v)
Control: adjuvant/physiological saline mixture, 1:1 (v/v) - Day(s)/duration:
- Day 0: Third injection of the three pairs of intradermal injections
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- Patch: 2 x 4 cm; approx. 0.4 g per patch
Treatment: 30 % test substance in petrolatum
Control: petrolatum - Day(s)/duration:
- Day 8: Occlusive dressing for 48 hours
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- Patch: 2 x 2 cm; approx. 0.2 g paste per patch; occlusive dressing
Both treatment and control: 10 % w/w test substance in petrolatum (one flank), vehicle alone (other flank) - Day(s)/duration:
- Day 21: occlusive dressing for 24 hours
- No. of animals per dose:
- Test group: 10
Control group: 5 - Details on study design:
- RANGE FINDING TESTS
Intradermal Induction
- Concentrations of test substance and vehicle: 1, 5, 10, and 30 % in petrolatum.
MAIN STUDY
Treatment schedule: A set of three intradermal induction injections was made on Day 0. An epidermal induction application was made once on Day 8. The epidermal challenge application was made once on Day 21.
A. INDUCTION EXPOSURE
- Intradermal Induction Injections: concentration of test substance and vehicle: 5.0 % in arachis oil.
- Pre-treatment: An area on the neck was shaved prior to the treatment.
Treatment (Day 0): Three pairs of intradermal injections (0.1 mL per injection) were made simultaneously as follows:
(1) adjuvant and physiological saline mixture, 1:1 (v/v)
(2) 5 % test substance in arachis oil
(3) 5 % test compound in the adjuvant physiological saline mixture.
Treatment (Day 8): Epidermal Application Induction
- Pre-treatment: The application sites were pre-treated the day before with 10 % sodium lauryl sulfate (open application).
- Concentration of test substance: 0.2 g paste of 10 % test substance in petrolatum
- Treatment: a filter paper patch was applied to the neck of the animals (patch 2 x 4 cm; occluded administration for 48 hours).
B. CHALLENGE EXPOSURE
- Epidermal Application Challenge (Day 21)
- Vehicle: Same as for epidermal application induction
- Concentration tested, test substance: approx. 0.2 g paste of 10 % (sub-irritant concentration) in petrolatum and the vehicle alone
- Treatment: the animals were tested on the flank with test substance in petrolatum and the vehicle alone (patch 2 x 2 cm; occluded administration for 24 hours). The concentrations of the test substance for the induction and challenge periods were determined on separate animals.
Reactions to challenge were recorded 24 and 48 h after removing the dressings and graded according to Draize scoring scale.
OTHER
- Individual body weights were recorded prior to dosing, on day 1 and at end of the test. - Challenge controls:
- No
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene (DNCB)
- Positive control results:
- The reliability check resulted in positive response in 10 (5 males and 5 females of 10 (100%) challenged guinea pigs at 24 and 48 hours after challenge. There were no irritant skin reactions in control groups. Based on results, DNCB was graded as an extreme sensitiser according to Magnusson and Kligman. See also Table 3 in 'Any other information on results incl. tables'.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 % w/v in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 % w/v in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 20
- 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:
- 10 % w/v in petrolatum
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- Scaling recorded in 2 males and 2 females after 24 hrs: very slight to well-defined erythema
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 % w/v in petrolatum
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- Scaling recorded in 4 males and in 5 females after 48 hrs: very slight to well-defined erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 % DNCB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Scaling recorded in 5 males and 5 females after 24 hrs: well-defined erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 % DNCB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Scaling recorded in 5 males and 5 females after 24 hrs: very slight yo well-defined erythema
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- According to the maximisation grading of Magnusson and Kligman the substance showed an extreme grade of skin-sensitising (contact allergenic) potential in albino guinea pigs.
- Executive summary:
A dermal sensitisation test was conducted with the test substance using the Maximisation procedure in accordance with OECD TG 406 following GLP principles. Male and female Pirbright White Strain (Tif: DHP) guinea pigs (10 vehicle control, 20 test group and 10 positive control) were included. A topical challenge dose of test substance was administered to both groups. The dose levels for the main study were selected on the basis of screening studies in separate animals to determine the primary irritation threshold concentration. The tested concentrations of 1, 5, 10 and 30% test substance in white petrolatum did not induce erythema reactions. 10% was used as a sub-irritant concentration for the challenge application. The sensitivity of the strain is checked every six months at performing laboratory with paraphenylene-diamine or Potassium-dichromate. In an amendment of the study report, the sensitivity of the strain was confirmed in a March 1988 test with 2,4-dinitrochlorobenzene (DNCB).
The induction was a two-stage operation as follows: at the first induction: 3 pairs of intradermal injections (0.1 mL per injection) were made simultaneously into the shaved neck of the guinea pigs as follows: adjuvant and saline (1:1); test compound 5 % in Oleum arachidis, and test compound test substance 5 % in the adjuvant saline mixture. Second induction entailed: one week later, approx. 0.4 g paste of 30 % test substance was incorporated in petrolatum and applied on a filter paper patch to the neck of the animals (patch 2x4 cm; occluded administration for 48 hours).
Two weeks after the epidermal induction application the animals were tested on the flank with approx. 0.2 g paste of 10 % test substance in petrolatum and the vehicle alone (patch 2x2 cm; occluded administration for 24 hours). Reactions to challenge were recorded 24 and 48 h after removing the dressings and graded according to Draize scoring scale. Individual body weights were recorded prior to dosing, on day 1 and at end of the test.
Following challenge with a 1 0% preparation of test substance in petrolatum, very slight to well-defined erythema was present in 9/20 test and 0/10 control animals, giving a net response of 45 %. No erythema was present in test or control animals when challenged with vehicle only. Very slight oedema was also present in one test animal at the test site at the 48 h reading. There were no deaths in the test and negative control groups. Body weights were unaffected by the treatment regimens and all guinea pigs gained weight over the course of the experimental phase.
Since up to 45 % of the animals were sensitised by the test substance at 10 % under the experimental conditions, the test substance is considered to be a moderate skin sensitiser in the guinea pig.
Reference
RESULTS
Following challenge with a 10 % preparation of test substance in petrolatum, very slight to well-defined erythema was present in 9/20 test and 0/10 control animals, giving a net response of 45 %.
No erythema was present in test or control animals when challenged with vehicle only. Very slight oedema was also present in one test animal at the test site at the 48 h reading. There were no deaths in the test and negative control groups.
Body weights were unaffected by the treatment regimens and all guinea pigs gained weight over the course of the experimental phase.
Table 2 Dermal reactions observed after challenge applications
Scored after |
24 hours |
48 hours |
|
Test group |
10 % test substance |
4/20 |
9/20 |
Vehicle only |
0/20 |
0/20 |
|
Negative/vehicle control |
10 % test substance |
0/10 |
0/10 |
Vehicle only |
0/10 |
0/10 |
|
Positive control (reference data) |
0.1 % DNCB |
10/10 (0/10 control) |
10/10 (0/10 control) |
Vehicle only |
0/10 (0/10 control) |
0/10 (0/10 control) |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitisation, Schneider 1988
A dermal sensitisation test was conducted with the test substance using the Maximisation procedure in accordance with OECD TG 406 following GLP principles. Male and female Pirbright White Strain (Tif: DHP) guinea pigs (10 vehicle control, 20 test group and 10 positive control) were included. A topical challenge dose of test substance was administered to both groups. The dose levels for the main study were selected on the basis of screening studies in separate animals to determine the primary irritation threshold concentration. The tested concentrations of 1, 5, 10 and 30 % test substance in white petrolatum did not induce erythema reactions. 10% was used as a sub-irritant concentration for the challenge application. The sensitivity of the strain is checked every six months at performing laboratory with paraphenylene-diamine or Potassium-dichromate. In an amendment of the study report, the sensitivity of the strain was confirmed in a March 1988 test with 2,4-dinitrochlorobenzene (DNCB).
The induction was a two-stage operation as follows: at the first induction: 3 pairs of intradermal injections (0.1 mL per injection) were made simultaneously into the shaved neck of the guinea pigs as follows: adjuvant and saline (1:1); test compound 5 % in Oleum arachidis, and test compound test substance 5 % in the adjuvant saline mixture. Second induction entailed: one week later, approx. 0.4 g paste of 30 % test substance was incorporated in petrolatum and applied on a filter paper patch to the neck of the animals (patch 2x4 cm; occluded administration for 48 hours).
Two weeks after the epidermal induction application the animals were tested on the flank with approx. 0.2 g paste of 10 % test substance in petrolatum and the vehicle alone (patch 2x2 cm; occluded administration for 24 hours). Reactions to challenge were recorded 24 and 48 h after removing the dressings and graded according to Draize scoring scale. Individual body weights were recorded prior to dosing, on day 1 and at end of the test.
Following challenge with a 10 % preparation of test substance in petrolatum, very slight to well-defined erythema was present in 9/20 test and 0/10 control animals, giving a net response of 45 %. No erythema was present in test or control animals when challenged with vehicle only. Very slight oedema was also present in one test animal at the test site at the 48 h reading. There were no deaths in the test and negative control groups. Body weights were unaffected by the treatment regimens and all guinea pigs gained weight over the course of the experimental phase.
Since up to 45 % of the animals were sensitised by the test substance at 10 % under the experimental conditions, the test substance is considered to be a moderate skin sensitiser in the guinea pig.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The test substance is not expected to be of concern for respiratory sensitisation. Following the recommended approach outlined in R.7.3.12.3, the test substance is not expected to be a respiratory sensitiser because the test substance is not di-isocyanate or protein. Furthermore, no structural warnings for respiratory sensitisation were found using the QSAR toolbox (v4.4).
Justification for classification or non-classification
Based on the available information the substance is classified as skin sensitiser category 1, H317: May cause an allergic skin reaction in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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