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EC number: 613-782-9 | CAS number: 65355-32-0
- 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
Endpoint summary
Administrative data
Description of key information
In an in vivo skin sensitisation study according to OECD guideline 406, the test item showed no positive responders and has not to be classified as a skin sensitizer (reference 7.4.1-1).
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:
- 2002-01-22 to 2002-02-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Directive 96/54/EEC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 07-1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed before development of the LLNA.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: about 5 weeks
- Weight at study initiation: 316 - 375 g
- Housing: 2 animals per Makrolon cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 47 - 62
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: Days 1 to 25 - Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- Group 1 (vehicle):
- cranial 0.1 mL Freud's complete adjuvant (FCA) + NaCl solution,
- medial 0.1 mL vehicle,
- caudal 0.1 mL FCA + NaCl solution
Group 2 (test item):
- cranial 0.1 mL FCA + NaCl solution,
- medial 0.1 mL test item (25 g/L in liquid paraffin),
- caudal 0.1 mL FCA with test item + NaCl solution (25 g test item/L preparation) - Day(s)/duration:
- day 1, single application
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Filter paper patch fully soaked with 1 mL of the test item preparation or vehicle.
Group 1 (vehicle): PEG 400
Group 2 (test item): Test item (200 g/L in PEG 400) - Day(s)/duration:
- over 48 hours, one week after intradermal injection (day 8)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Fixing filter papers fully loaded with 0.5 mL of test item preparation or soaked with 0.5 mL PEG 400.
Group 1 (vehicle): PEG 400
Group 2 (test item): Test item (25 g/L in PEG 400) - Day(s)/duration:
- over 24 hours, 2 weeks after topical induction (day 22)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Pretest: 5 females
Group 1 (negative controls): 5 females
Group 2 (test material group): 10 females - Details on study design:
- RANGE FINDING TESTS: To determine the concentrations suitable for the main study, a pre-test with single intradermal or topical administrations of the vehicle and of the test item preparations were performed. Intradermal injections were given to one animal. Four further animals were used to determine the topical concentrations for the main study. Two of the guinea pigs were exposed for 48 hours without pre-treatment to determine the concentrations for the dermal induction. The other two animals were treated according to the control group including intradermal injections with FCA. One week after topical induction, the two animals of the pretest group were exposed for 24 hours to different test material concentrations to find out the challenge concentration. In the pre-test, the following concentrations were used:
1. Test item with liquid paraffin as vehicle:
- intradermal: 50, 25, 10, 5 and 1 g/L
2. Test item with polyethylene glycol 400 as vehicle:
- topical: 400, 200, 100 and 10 g/L
- topical with FCA: 150, 100, 50 and 10 g/L
MAIN STUDY
A. INDUCTION EXPOSURE
- No of exposures: 2 (One induction on day 1 (intradermal injection) and another one one week after intradermal injections (topical application))
- Exposure period: 3 weeks in total (including 2 weeks induction period)
- Test groups: 2 (vehicle and test item)
- Control group: liquid paraffin (intradermal injection) and polyethylene glycol (topical applications)
- Site: shoulder region, three treatments on each side of the spinal column
- Duration: single intradermal injection, after one week topical application for 48 h under occlusive conditions
- Concentrations: 25 g/L test item in 0.1 mL (intradermal injection); 200 g/L in 1 mL (topical application)
B. CHALLENGE EXPOSURE
- No of exposures: 1 (two weeks after topical induction)
- Exposure period: 24 hours with occlusive plastic tapes, then another 48 hours
- Test groups: 25 g/L test item in polyethylene glycol 400
- Control group: polyethylene glycol 400
- Site: shaven sides of the animals
- Concentrations: 25 g/L test item in 0.5 mL
- Evaluation (hr after challenge): 48 hours and 72 hours - Challenge controls:
- as challenge control, 5 female guinea pigs were treated with polyethylene glycol 400
- Positive control substance(s):
- not required
- Remarks:
- The sensitivity of the test system had been demonstrated periodically. The control was carried out with alpha-Hexylcinnamaldehyde as a sensitizer
- Positive control results:
- The sensitivity of the test system has to be demonstrated periodically. The control was carried out with α-Hexylcinnamaldehyde as a sensitiser.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The sensitivity of the test system has to be demonstrated periodically. The control was carried out with α-Hexylcinnamaldehyde as a sensitiser.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The sensitivity of the test system has to be demonstrated periodically. The control was carried out with α-Hexylcinnamaldehyde as a sensitiser.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vivo skin sensitisation study according to OECD guideline 406, the test item showed no positive responders and has not to be classified as a skin sensitizer.
- Executive summary:
The test item was evaluated for skin sensitizing properties in the guinea pig maximization test according to Magnusson and Kligman (1969). 5 female guinea pigs in the negative control group (group 1) treated with the vehicles (liquid paraffin and polyethylene glycol 400) and 10 females in the test item group (group 2) were investigated. Induction included intradermal injection of the test item preparation in liquid paraffin (25 g/L with and without Freud's complete adjuvant) on experimental day 1, and topical apllication of the test item preparation in polyethylene glycon 400 (200 g/L) on day 8 of the experimental part. Challenge by topical application of the test item preparation on polyethylene gylcol 400 (25 g/L) was performed two weeks after topical induction. After challenge, no positive reactions in the test item treated skin sites at both readings (24 and 72 h after start of challenge) were seen.
Reference
Table 1:Findings after challenge
Group |
Induction with |
Challenge with |
Positive animals (h after challenge) |
Positive animals overall |
|
48 h |
72 h |
||||
1 |
Vehicles* |
PEG 400 |
0/5 |
0/5 |
0/5 |
|
Test item # |
0/5 |
0/5 |
0/5 |
|
2 |
Test item |
Test item |
0/10 |
0/10 |
0/10 |
|
PEG 400 |
0/10 |
0/10 |
0/10 |
Vehicles * = liquid paraffin and PEG 400
# = testing for primary irritation
Table 2. Body weight
|
Mean body weight in g on experimental day |
Difference day 1 to 25 |
||||
Group |
1 |
8 |
15 |
22 |
25 |
|
1 (vehicle) |
332 |
395 |
441 |
481 |
502 |
+170 |
2 (test material) |
353 |
419 |
471 |
529 |
543 |
+190 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Skin sensitisation in vivo
The test item was evaluated for skin sensitizing properties in the guinea pig maximization test according to Magnusson and Kligman (1969). 5 female guinea pigs in the negative control group (group 1) treated with the vehicles (liquid paraffin and polyethylene glycol 400) and 10 females in the test item group (group 2) were investigated. Induction included intradermal injection of the test item preparation in liquid paraffin (25 g/L with and without Freud's complete adjuvant) on experimental day 1, and topical apllication of the test item preparation in polyethylene glycon 400 (200 g/L) on day 8 of the experimental part. Challenge by topical application of the test item preparation on polyethylene gylcol 400 (25 g/L) was performed two weeks after topical induction. After challenge, no positive reactions in the test item treated skin sites at both readings (24 and 72 h after start of challenge) were seen.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data the test item is not classified as skin sensitising according to Regulation (EC) No 1272/2008 (CLP), as amended for fifteenth time in Regulation (EU) No 2020/217.
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