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EC number: 944-855-6 | CAS number: 199445-85-7
- 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, EU Method B.6 - Buehler method, female guinea pig (Anon., 1991)
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:
- 07 December 1990 - 14 February 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- The methodology used in this study was equivalent to the current guideline requirements for an OECD 406 study. The study was conducted in accordance with GLP and all relevant modern validity criteria were met.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not applicable
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The procedures used were modified from those described by Buehler, E.V., Arch. Dermatol., 91, 171, 1965 and updated by Buehler, E.V. and Ritz, H.L., Current Concepts in Cutaneous Toxicology, pp 25-40, 1980. This test was one of the accepted methods for skin sensitisation listed in document L251m an EEC Commission Directive (84/449/EEC) of 25 April 1984.
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was conducted prior to the LLNA method becoming the default approach for skin sensitisation under EU chemical control legislation. At the time of conducting this study, the Buehler method was considered the most appropriate test to assess skin sensitisation potential.
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerator (4ºC) - Dark
- Stability under test conditions: Stable.
- Solubility and stability of the test substance in the solvent/vehicle: N/A
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: N/A - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Recognised supplier
- Females (if applicable) nulliparous and non-pregnant: Not reported
- Microbiological status of animals, when known: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: 300 - 350 g
- Housing: Stainless stell cage 85 x 57 x 25 cm with mesh floors
- Diet (e.g. ad libitum): FDI SQC guinea pig diet suppled ad libitum
- Water (e.g. ad libitum): Tap water supplied ad libitum
- Acclimation period: 5 days (prelim test) 10 days (main test)
- Indication of any skin lesions: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13 - 23 ºC
- Humidity (%): 30 - 60 % RH
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12:12
- IN-LIFE DATES: Not reported - Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 25 % (v/v) / 0.5 mL
- Day(s)/duration:
- Days 0, 8 and 15 / 6 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 25% (v/v) on left flank & 12.5% on right flank / 0.5 mL
- Day(s)/duration:
- Day 29 / 6 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Ethanol
- Concentration / amount:
- 1 % (v/v) on right flank & 0.2 % (v/v) on left flank / 0.5 mL
- Day(s)/duration:
- 36 / 6 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Preliminary test: 4 individuals
Main test: 20 individuals (10 test and 10 control) - Details on study design:
- RANGE FINDING TESTS: 4 guinea pigs were exposed to 100, 50, 25 and 12.5 % v/v concentrations of the test substance (prepared in ethanol). An aliquot (0.5 mL) of the test solution was applied by way of a 2 cm patch secured to the animal at one of four sites on the back of the animal. Patches were removed after 6 h contact. Animals were examined after 24 and 48 h under a standard light to comply with the requirements of BS 950 Part 1. Presence of erythema and/or oedema was recorded using a point scoring system (Table 1).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 15 days
- Test groups: 10 individuals
- Control group: 10 individuals
- Site: Shoulder region
- Frequency of applications: Application once a week for 3 weeks
- Duration: 6 h
- Concentrations: 25 % v/v
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (per concentration)
- Day(s) of challenge: 29
- Exposure period: 6 h
- Test groups: 10 individuals
- Control group: 10 individuals
- Site: Flank
- Concentrations: 12.5, 6.25, 1.0, 0.2 % v/v
- Evaluation (hr after challenge): 24 and 48 h
OTHER: - Positive control substance(s):
- no
- Positive control results:
- No positive control substance
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 12.5 % v/v
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12.5 v/v
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 6.25 % v/v
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 6.25 % v/v
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.0 % v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0 % v/v
- 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:
- test chemical
- Dose level:
- 0.2 v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 % v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 12.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 12.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 6.25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 6.25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other:
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test substance produced a delayed dermal hypersensitiviy in guinea pig using test substance concentrations ≥ 6.25 % v/v. The test demonstrated the failure to elicit a response using test substance concetrations of ≤ 1.0 % v/v.
- Executive summary:
The skin sensitisation potential of the test substance was assessed in guinea pig using the Beuhler method similar to EU Method B.6 and GLP.
In a preliminary test, 4 guinea pigs were exposed to 100, 50, 25 and 12.5 % v/v concentrations of the test substance (prepared in ethanol). An aliquot (0.5 mL) of the test solution was applied by way of a 2 cm patch secured to the animal at one of four sites on the back of the animal. Patches were removed after 6 h contact. Animals were examined after 24 and 48 h under a standard light to comply with the requirements of BS 950 Part 1. Presence of erythema and/or oedema was recorded using a point scoring system. A test concentration of 25 % v/v was selected for application in the main test as it was the lowest concentration tested that elicited a response.
Twenty individuals within the weight range 400 - 478 g were selcted for the main test, 10 of which were allocated as control animals and the remaining 10 as test animals. On the first day of the test a 0.5 mL aliquot of the test solution (25 % v.v, prepared in ethanol) was applied to the shoulder region of each of the test animals by way of a 2 x 2 cm patch. The patch was occluded using surgical tape and covered using and elastic bandage. The dressings were removed after 6 h contact time. The dosing process was repeated weekly for a total of 3 weeks (Day 1, 8 and 15) during which time the control animals were left untreated. The challenge test was conducted on Day 29, after a two week rest period. Test solutions prepared at 12.5 % v/v and 6.25 % v/v (prepared in ethanol) were applied, as previously described, to the left and right flanks of each test animal. The control animals were left untreated. The contact patches were removed after 6 h contact time. Animals were examined visually 24 h and 48 h after test item application for erthema or oedema. A second challenge test was conducted 5 days after completion of the first challenge test by applying test solutions of concentration 1.0 % v/v and 0.2 % v/v to virgin sites on the flanks of each of the test animals. The procedures applied were the same as those employed for the first challenge test. During visual assessment animals were scored on two indices, incidence and severity.
During the observation period nine test animals exhibited responses following the challenge application of 12.5 and 6.25 % v/v solution that equated to a reaction score of 1 or greater. No response was observed in the control animals or test animals when treated at 1.0 and 0.2 % v/v.
It was concluded that the test substance produced a delayed dermal hypersensitivity in the guinea pig at concentrations ≥ 6.25 % v/v.
Reference
Table 2 Main Test Skin Reaction Scores
Animal |
Test item Concentration - hours after challenge |
|||||||
|
12.5 % v/v - 24 h |
12.5 % v/v- 48 h |
6.25 % v/v- 24 h |
6.25 % v/v- 48 h |
1.0 % v/v- 24 h |
1.0 % v/v- 48 h |
0.2 % v/v- 24 h |
0.2 % v/v- 48 h |
1 |
2 |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
2 |
0.5 |
0.5 |
0.5 |
0.5 |
0 |
0 |
0 |
0 |
3 |
3 |
2 |
2 |
1 |
0 |
0 |
0 |
0 |
4 |
1 |
0.5 |
1 |
1 |
0 |
0 |
0 |
0 |
5 |
1 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
6 |
2 |
2 |
1 |
0.5 |
0 |
0 |
0 |
0 |
7 |
2 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
8 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
9 |
2 |
1 |
1 |
0.5 |
0 |
0 |
0 |
0 |
10 |
2 |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
Table 3 Bodyweights of Test Animals
Animal |
Bodyweight (g) |
||
|
Day -1 |
Day 31 |
Day 38 |
1 |
446 |
689 |
705 |
2 |
416 |
690 |
753 |
3 |
430 |
677 |
719 |
4 |
454 |
766 |
833 |
5 |
400 |
610 |
632 |
6 |
478 |
701 |
774 |
7 |
455 |
683 |
741 |
8 |
407 |
651 |
725 |
9 |
472 |
594 |
791 |
10 |
426 |
659 |
702 |
Mean |
438 |
672 |
738 |
S.D. |
26.8 |
48.3 |
55.3 |
Table 3 Bodyweights of Control Animals
Animal |
Bodyweight (g) |
||
|
Day -1 |
Day 31 |
Day 38 |
1 |
401 |
536 |
572 |
2 |
455 |
744 |
794 |
3 |
429 |
755 |
821 |
4 |
401 |
577 |
635 |
5 |
404 |
649 |
700 |
6 |
429 |
727 |
788 |
7 |
405 |
634 |
680 |
8 |
420 |
615 |
641 |
9 |
461 |
757 |
824 |
10 |
431 |
680 |
745 |
Mean |
424 |
667 |
720 |
S.D. |
21.8 |
74.1 |
87.6 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The skin sensitisation potential of the test substance was assessed in guinea pig using the Beuhler method similar to EU Method B.6 and GLP.
In a preliminary test, 4 guinea pigs were exposed to 100, 50, 25 and 12.5 % v/v concentrations of the test substance (prepared in ethanol). An aliquot (0.5 mL) of the test solution was applied by way of a 2 cm patch secured to the animal at one of four sites on the back of the animal. Patches were removed after 6 h contact. Animals were examined after 24 and 48 h under a standard light to comply with the requirements of BS 950 Part 1. Presence of erythema and/or oedema was recorded using a point scoring system. A test concentration of 25 % v/v was selected for application in the main test as it was the lowest concentration tested that elicited a response.
Twenty individuals within the weight range 400 - 478 g were selcted for the main test, 10 of which were allocated as control animals and the remaining 10 as test animals. On the first day of the test a 0.5 mL aliquot of the test solution (25 % v.v, prepared in ethanol) was applied to the shoulder region of each of the test animals by way of a 2 x 2 cm patch. The patch was occluded using surgical tape and covered using and elastic bandage. The dressings were removed after 6 h contact time. The dosing process was repeated weekly for a total of 3 weeks (Day 1, 8 and 15) during which time the control animals were left untreated. The challenge test was conducted on Day 29, after a two week rest period. Test solutions prepared at 12.5 % v/v and 6.25 % v/v (prepared in ethanol) were applied, as previously described, to the left and right flanks of each test animal. The control animals were left untreated. The contact patches were removed after 6 h contact time. Animals were examined visually 24 h and 48 h after test item application for erthema or oedema. A second challenge test was conducted 5 days after completion of the first challenge test by applying test solutions of concentration 1.0 % v/v and 0.2 % v/v to virgin sites on the flanks of each of the test animals. The procedures applied were the same as those employed for the first challenge test. During visual assessment animals were scored on two indices, incidence and severity.
During the observation period nine test animals exhibited responses following the challenge application of 12.5 and 6.25 % v/v solution that equated to a reaction score of 1 or greater. No response was observed in the control animals or test animals when treated at 1.0 and 0.2 % v/v.
It was concluded that the test substance produced a delayed dermal hypersensitivity in the guinea pig at concentrations ≥ 6.25 % v/v.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with Regulation (EC) No 1272/2008, the substance is classified as a Skin Sensitiser Category 1B.
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