Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 448-300-4 | CAS number: 88642-03-9
- 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
Based on the results of an OECD 406 compliant study, the test item showed no dermal sensitising potential in guinea pigs.
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:
- 2004-03-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in 2004, when the GPMT was still an accepted method to evaluate the skin sensitisation potential of a substance.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Microbiological status of animals: SPF
- Age at study initiation: adult
- Weight at study initiation: 330 - 408 g
- Housing: two or three animals per cage; polycarbonate (macrolone type IV, floor area 1800 cm2)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature: 21 +/- 3 °C
- Humidity: 55 +/- 15 %
- Air changes: 10 per hr
- Photoperiod: 12 / 12 hrs dark / hrs light - Route:
- intradermal and epicutaneous
- Vehicle:
- other: sunflower oil; ethanol/diethylphthalate 1:1
- Concentration / amount:
- 1.25 % w/v (intradermal)
75 % w/v (epicutaneous) - Day(s)/duration:
- 0 and 7
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol/diethylphthale (1:1)
- Concentration / amount:
- 50 % (w/v)
- Day(s)/duration:
- 21
- No. of animals per dose:
- 10 (test group)
5 (control group) - Details on study design:
- RANGE FINDING TESTS: yes
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: intradermal injection (once); epicutanous 48 h
- Test groups: 1
- Control group: 1
- Frequency of applications: on day 0 and day 7
Induction
Day -1 - Shaving of the shoulder region
An area of dorsal skin 4 x 6 cm in the scapular region was clipped free of hair with an electric clipper.
Day 0 - Intradermal injection in the shoulder region
Three pairs of intradermal injections were given simultaneously into this area. Each dose was 0.1 mL. The first two pairs of injections were given close to each other and most cranially, whereas the third pair of injections was given towards the caudal part of the test area.
1st pair: Freund's complete adjuvant (FCA) mixed 1:1 with sterile distilled water
2nd pair: - Group 1: SY04/F31358 1.25 °A) (w/v) in sunflower oil
- Group 2: sunflower oil
3rd pair: - Group 1: Equal amounts of SY04/F31358 2.5 % (w/v) in sunflower oil and FCA/water in the ratio 1:1 (v/v)
- Group 2: Equal amounts of sunflower oil and FCA/ water in the ratio 1:1 (v/v)
Day 2 — Observation of skin reaction
Two days after the intradermal induction the injection sites possible skin irritations.
Day 6 - Shaving/ Observation of skin reactions
Six days after the intradermal induction, the same 4 x 6 cm scapular area was clipped free of hair and examined for possible skin reactions.
Day 7 — Dermal induction in the shoulder region
A paper patch (Whatman No. 3M, 2 x 4 cm) was saturated with an amount of 0.25 mL of the 75 % test item (group 1) or the vehicle (group 2). The patch was placed on the skin and covered with impermeable adhesive bandage (Blenderm 5 x 7 cm). This was firmly secured with tape (Gothaplast 5 cm width) wrapped round the trunk. The dressing was left in place for 48 hours.
Day 9 — Observation of skin reactions
After the patch removal the application sites were examined for skin reactions.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: 24 h
- Test groups: 1
- Control group: 1
- Evaluation (hr after challenge): 24 and 48 h after removal of the patch
Challenge
Day 20 – Shaving
Hair was removed with an electric clipper and an electric razor from a 4 x 6 cm area from the left flank of the guinea pigs.
Day 21 - Topical application at the flank region
A paper patch (Whatman No. 3M, 2 x 2 cm) was saturated with an amount of 0.1 mL of the 50 % (w/v) test item and placed on the guinea pigs. The patches were covered with impermeable adhesive bandage (Blen erm 4 x 5 cm width) and secured with tape (Gothaplast 5 cm width) wrapped round the trunk. After 24 hours of exposure the patches and tape were removed.
Day 23 and 24 - Observation of skin reactions
Each challenge site was examined approx. 24 and 48 hours after the removal of the patch. About three hours before the 24-hour-reading the sites were clipped and shaved in order to facilitate the evaluation.
- Positive control substance(s):
- yes
- Remarks:
- At regular intervals the sensitivity and reliability of the experimental technique was assessed using alpha-HEXYLCINNAMALDEHYDE, TECH., 85 % (10% for intradermal induction and undiluted for topical induction and challenge).
- Positive control results:
- The latest positive control study was performed from November 6th, 2002 to November 20th, 2002 in which 100 % of the animals responded positively.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % (w/v) at challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % (w/v) at challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- other: 1st and 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- other: first and second reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100 % at challenge
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 100 % of the tested animals responded positively (no absolute numbers are given in the report)
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the test item showed no dermal sensitising potential in guinea pigs.
- Executive summary:
The dermal sensitizing potential of the test item was modified investigated according to one of the methods recommended in the OECD Guidelines o. 406, "Skin Sensitization", 1992 and the EEC Guideline "EEC 92/69 part 6B", 1996.
The delayed contact hypersensitivity test used was the Guinea Pig Maximization Test described by B. Magnusson and A. M. Kligman.
15 animals divided into a test group of 10 animals and a control group of 5 animals were included in the study. The study comprised an induction and a challenge phase. The animals in the test group were induced with the test item whereas the animals in the control group were induced with the vehicle only. The induction procedure included intradermal injections and a closed patch topical application one week apart. All animals were challenged by a closed patch topical application of the test item for 24 hours. The challenge procedure included a closed patch topical treatment of the test item an the flank 3 weeks after the intradermal injection. The skin reactions were evaluated 24 and 48 hours after the challenge application. A 1.25 % (w/v) test item concentration was used for the intradermal induction and a 75 % (w/v) test item concentration for the topical induction. A 50 % (w/v) test item concentration was used for the challenge application. Under the experimental conditions described in this final report no evidence of delayed contact hypersensitivity was seen after the treatment with the test item.
Reference
Table 1 Challenge responses and body weights of test item treated group
Animal number |
24-hour-observation |
48-h-observation |
Body weight (g) |
|||
Left anterior |
Left posterior |
Left anterior |
Left posterior |
Day 0 |
Day 24 |
|
1 |
0 |
0 |
0 |
0 |
330 |
442 |
2 |
0 |
0 |
0 |
0 |
408 |
510 |
3 |
0 |
0 |
0 |
0 |
406 |
510 |
4 |
0 |
0 |
0 |
0 |
340 |
450 |
5 |
0 |
0 |
0 |
0 |
390 |
475 |
6 |
0 |
0 |
0 |
0 |
383 |
502 |
7 |
0 |
0 |
0 |
0 |
343 |
510 |
8 |
0 |
0 |
0 |
0 |
379 |
496 |
9 |
0 |
0 |
0 |
0 |
337 |
470 |
10 |
0 |
0 |
0 |
0 |
402 |
496 |
Table 2 Challenge responses and body weights of vehicle control group
Animal number |
24-hour-observation |
48-h-observation |
Body weight (g) |
|||
Left anterior |
Left posterior |
Left anterior |
Left posterior |
Day 0 |
Day 24 |
|
11 |
0 |
0 |
0 |
0 |
380 |
466 |
12 |
0 |
0 |
0 |
0 |
390 |
485 |
13 |
0 |
0 |
0 |
0 |
364 |
465 |
14 |
0 |
0 |
0 |
0 |
375 |
437 |
15 |
0 |
0 |
0 |
0 |
384 |
497 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation, OECD 406
The dermal sensitizing potential of the test item was investigated according to one of the methods recommended in the OECD Guidelines o. 406, "Skin Sensitization", 1992 and the EEC Guideline "EEC 92/69 part 6B", 1996. The delayed contact hypersensitivity test used was the Guinea Pig Maximization Test described by B. Magnusson and A. M. Kligman. 15 animals divided into a test group of 10 animals and a control group of 5 animals were included in the study. The study comprised an induction and a challenge phase. The animals in the test group were induced with the test item whereas the animals in the control group were induced with the vehicle only. The induction procedure included intradermal injections and a closed patch topical application one week apart. All animals were challenged by a closed patch topical application of the test item for 24 hours. The challenge procedure included a closed patch topical treatment of the test item an the flank 3 weeks after the intradermal injection. The skin reactions were evaluated 24 and 48 hours after the challenge application. A 1.25 % (w/v) test item concentration was used for the intradermal induction and a 75 % (w/v) test item concentration for the topical induction. A 50 % (w/v) test item concentration was used for the challenge application. Under the experimental conditions described in this final report no evidence of delayed contact hypersensitivity was seen after the treatment with the test item.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification,
Labelling, 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 does not require classification according
to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in
Regulation (EU) No 2017/776.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.