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EC number: - | CAS number: -
- 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
Guinea Pig Maximization Test: negative (Not a dermal sensitizer)
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:
- 1999-07-08 to 1999-11-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Scientifically valid and well documented guinea pig maximization test. The testing using the guinea pig maximisation test protocol was completed on 17 November 1999. The LLNA 429 was not formally adopted by the OECD until 22 July 2010.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Young adult, Hartley-derived albino guinea pigs were received at SLI from Hilltop Lab Animals, Inc., Scottdale, Pennsylvania. Upon receipt, plastic ear tags displaying unique identification numbers were used to individually identify the animals. Cage cards displaying at least the study number, animal number and sex were affixed to each cage. The animals were housed individually in suspended stainless steel cages. All housing and care were based on the standards recommended by the Guide of the Care of Use of Laboratory Animals
The animal toom temperature and relative humidity ranges were 64-74°F and 54-89%, respective. Environmental control equipment was monitored and adjusted as necessary to minimise fluctuation in the animal room environment. Light timers were set to maintain a 12-hourlight/12-hour dark cycle and room ventilation was set to produce 10-15 air changes/hour. The room temperature and relative humidity were recorded a minimum of once daily. - Route:
- epicutaneous, semiocclusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 5.0% / 0.1 ml
- Day(s)/duration:
- 0
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 100% / 0.8 ml
- Day(s)/duration:
- 6
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1% / 0.3 ml
- Day(s)/duration:
- 21
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1% / 0.3 ml
- Day(s)/duration:
- 29
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 5 animals/sex/dose
- Details on study design:
- This study consisted of an intradermal range-finding group, two topical range-finding groups, a test group, a challenge control group and a rechallenge control group.
- Challenge controls:
- 0.1% / 0.3 ml Santicizer 2148 on 25 mm Hilltop Chamber
- Positive control substance(s):
- no
- Remarks:
- Hexylcinnamaldehyde used as noncpncurrent positive control. Tested at the facility within 6 month of the test with Santicizer 2148
- Positive control results:
- Hexylcinnamaldehyde was used as a nonconcurrent positive control and tested at the facility within 6 months of the Santicizer 2148 test. The positive control produced evidence of dermal sensitization (mean dermal score at 24 and 48 hours were 1.2 and 0.8, respectively for a 1% challenge vs. 0.2 and 0.1 for control; mean dermal scores at 24 and 48 hours were 0.7 and 0.6, respectively for 0.5% rechallenge vs. 0.0 and 0.0 for control.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.8 mL (100% concentration)
- Remarks on result:
- other: Mean dermal score = 0.1
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.8 mL (100% concentration)
- Remarks on result:
- other: Mean dermal score = 0.1
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.8 mL (100% concentration)
- Remarks on result:
- other: Mean dermal score = 0.3
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.8 mL (100% concentration)
- Remarks on result:
- other: Mean dermal score = 0.2
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- score of 1 in erythema
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- score of 1 - slight, but confluent or moderate patchy erythema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- score of 0.5 in erythema
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- score of 0.5 - slight patchy erythema
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1% challenge
- Remarks on result:
- other: Mean dermal score = 1.2
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1% challenge
- Remarks on result:
- other: Mean dermal score = 0.8
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5%
- Remarks on result:
- other: Mean dermal score = 0.7
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.5%
- Remarks on result:
- other: Mean dermal score = 0.6
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- One test animal at challenge (0.1%) had a score of 1 in erythema at the 24-hour scoring interval and a score of ± at the 48-hour scoring interval. At rechallenge (0.1%) the same animal had a score of ± at the 24 and 48 hour scoring intervals. Since none of the animals at test and rechallenge had an erythema score high than ±, Santicizer 2148 is not considered to be a contact sensitizer in guinea pigs. The results of the α-Hexylcinnamaldehyde historical control study demonstrated that a valid test was performed and indicated that the test design would detect potential contract sensitizer
- Executive summary:
The dermal sensitisation potential of Santicizer 2148 was evaluated in Harley-derived albino guinea pigs. 5 male and 5 female guinea pigs received intradermal injections of 5.0% w/v Santicizier 2148 in propylene glycol along with injections of FCA and Santicizer 2148 in FCA. One week later, the test animals received a topical application of 100% Santicizer 2148. Challenge and rechallenge control animals received similar intradermal and topical treatments except propylene glycol was used in place of the test article/ following a two-week rest period, a challenge was performed whereby the 10 test and 10 challenge control guinea pigs were topically treated with 0.1% w/v Santicizer 2148 in propylene glycol. Challenge responses in the test animals were compared with those of the challenge control animals. Following an eight-day rest period, a rechallenge was performed whereby the 10 test animals and 10 previously untreated (naïve) rechallenge control guinea pigs were topically treated with 0.1% w/v Santicizer 2148 in propylene glycol. Rechallenge responses in the test animals were compared with those of the rechallenge control animals.
One test animal at challenge (0.1%) had a score of 1 in erythema at the 24-hour scoring interval and a score of ± at the 48-hour scoring interval. At rechallenge (0.1%) the same animal had a score of ± at the 24 and 48 hour scoring intervals. Since none of the animals at test and rechallenge had an erythema score high than ±, Santicizer 2148 is not considered to be a contact sensitizer in guinea pigs. The results of the α-Hexylcinnamaldehyde historical control study demonstrated that a valid test was performed and indicated that the test design would detect potential contract sensitizer.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Table 1: A dermal sensitisation study in guinea pigs – individual challenge data for test group
Animal no./sex |
Dermal scores (0.1%) |
|
24hr |
48hr |
|
G1811/M |
± |
± |
G1812/M |
0 |
0 |
G1813/M |
0 |
0 |
G1814/M |
± |
0 |
G1815/M |
0 |
0 |
G1920/F |
± |
0 |
G1921/F |
± |
± |
G1922/F |
± |
± |
G1923/F |
0 |
0 |
G1924/F |
1 |
± |
MEAN |
0.4 |
0.2 |
± = 0.5
Score of 0.5 = slight patchy erythema
Score of 1 = slight, but confluent or moderate patchy erythema
Table 2. A dermal sensitisation study in guinea pigs – individual challenge data for control group
Animal No. / Sex |
Dermal Scores (0.1%) |
|
24 hr |
48 hr |
|
G1816/M |
0 |
0 |
G1817/M |
0 |
0 |
G1818/M |
0IT |
0 |
G1819/M |
0IT |
0 |
G1821/M |
0IT |
0 |
G1925/F |
0IT |
0 |
G1926/F |
±IT |
0 |
G1927/F |
0IT |
±IT |
G1928/F |
±IT |
± |
G1929/F |
0IT |
0 |
Mean |
0.1 |
0.1 |
Note: For purpose of calculation ± = 0.5
IT: dermal irritation outside of test site
±: Erythema Grade ± slight patchy erythema
Table 3: A dermal sensitisation study in guinea pigs – individual rechallenge data for test group
Animal no./sex |
Dermal scores (0.1%) |
|
24hr |
48hr |
|
G1811/M |
± |
0 |
G1812/M |
± |
± |
G1813/M |
0 |
0 |
G1814/M |
± |
± |
G1815/M |
± |
0 |
G1920/F |
0 |
0 |
G1921/F |
± |
0 |
G1922/F |
± |
0 |
G1923/F |
0 |
0 |
G1924/F |
± |
0 |
MEAN |
0.4 |
0.2 |
± = 0.5
Score of 0.5 = slight patchy erythema
Score of 1 = slight, but confluent or moderate patchy erythema
Table 4: A dermal sensitisation study in guinea pigs – individual rechallenge data for control group
Animal No. / Sex |
Dermal Scores (0.1%) |
|
24 hr |
48 hr |
|
G1822/M |
± |
± |
G1823/M |
0IT |
0 |
G1824/M |
0 |
0 |
G1825/M |
± |
0 |
G1826/M |
0IT |
0 |
G1930/F |
± |
0 |
G1931/F |
±IT |
± |
G1932/F |
0IT |
0IT |
G1933/F |
0 |
0 |
G1934/F |
0IT |
± |
Mean |
0.3 |
0.2 |
Note: For purpose of calculation ± = 0.5
IT: dermal irritation outside of test site
±: Erythema Grade ± slight patchy erythema
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The dermal sensitisation potential of Santicizer 2148 was evaluated in Harley-derived albino guinea pigs (Springborn Laboratories, Inc., 1999a). 5 male and 5 female guinea pigs received intradermal injections of 5.0% w/v Santicizier 2148 in propylene glycol along with injections of FCA and Santicizer 2148 in FCA. One week later, the test animals received a topical application of 100% Santicizer 2148. Challenge and rechallenge control animals received similar intradermal and topical treatments except propylene glycol was used in place of the test article/ following a two-week rest period, a challenge was performed whereby the 10 test and 10 challenge control guinea pigs were topically treated with 0.1% w/v Santicizer 2148 in propylene glycol. Challenge responses in the test animals were compared with those of the challenge control animals. Following an eight-day rest period, a rechallenge was performed whereby the 10 test animals and 10 previously untreated (naïve) rechallenge control guinea pigs were topically treated with 0.1% w/v Santicizer 2148 in propylene glycol. Rechallenge responses in the test animals were compared with those of the rechallenge control animals.
One test animal at challenge (0.1%) had a score of 1 in erythema at the 24-hour scoring interval and a score of ± at the 48-hour scoring interval. At rechallenge (0.1%) the same animal had a score of ± at the 24 and 48 hour scoring intervals. Since none of the animals at test and rechallenge had an erythema score high than ±, Santicizer 2148 is not considered to be a contact sensitizer in guinea pigs. The results of the α-Hexylcinnamaldehyde historical control study demonstrated that a valid test was performed and indicated that the test design would detect potential contract sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Santicizer 2148 Plasticizer does not meet the criteria for classification as a skin sensitizer under EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 ortheUN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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