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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2014-12-15 to 2015-02-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant study performed according to an internationally-recognized guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Max T° at 23.5°C instead of 23°C. Laboratory bedding Grade 5
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2012-03-12
- Type of study:
- guinea pig maximisation test
Test material
- Test material form:
- other: liquid
- Details on test material:
- Name: DP1268
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: (LAL/HA/BR)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: LAB-ÁLL Bt. Budapest, 1174 Hunyadi u. 7.
- Age at study initiation: 8-9 weeks at onset the treatment
- Weight at study initiation: 464 – 503 g
- Housing: Animals were housed in macrolon cages size IV, with 5 animals/cage to allow socialization
- Diet (e.g. ad libitum): Animals received Cunigra Diet for Rabbits, produced by Bonafarm-Bábolna Takarmány Ltd., Hungary during the main test, ad libitum. This diet is classified as being suitable for guinea pigs as the vitamin D level is high enough to meet the needs of this species. This is the diet used by the breeder/supplier and animals are fully adapted to this diet on arrival.
- Water (e.g. ad libitum): Animals received tap water from municipal supply as for human consumption, containing 50 mg/100 mL ascorbic acid, ad libitum. The drinking water is routinely analysed and is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
- Acclimation period: 34 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 – 23.5 °C
- Humidity (%): < 24 – 41 %
- Air changes (per hr): 15-20 air exchange/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily from 6 a.m. to 6 p.m. (artificial light)
IN-LIFE DATES: From 2015-01-06 to 2015-01-30
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Intra-dermal Induction Exposure (Main study I): 5% (w/v in Saline
Dermal Indicution Exposure (Main Study II): 100% undiluted
Challenge Epxosure (Main study III): 100% undiluted and 50% w/v in saline (Safeguared dose)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Intra-dermal Induction Exposure (Main study I): 5% (w/v in Saline
Dermal Indicution Exposure (Main Study II): 100% undiluted
Challenge Epxosure (Main study III): 100% undiluted and 50% w/v in saline (Safeguared dose)
- No. of animals per dose:
- Control: 5 animals
Treated group: 10 animals - Details on study design:
- RANGE FINDING TESTS:
The concentration of test item to be used for each induction exposure should be well tolerated systemically and should be the highest to cause no more than mild-tomoderate skin irritation. The concentration used for the challenge exposure should be the highest non-irritant dose.
The day prior to the test, the hair was removed from the right and left surface of the animals (approximately 5 x 5 cm). The hair removal was performed carefully to ensure animals are closely shaven.
A series of test item concentrations was tested to identify the primary irritation following intra-dermal injection and dermal application: 0.5, 1, 2.5 and 5% (w/v)
concentrations were used for intra-dermal injection and 25, 50, 75% (w/v) and 100% (undiluted) for dermal application. Local effects were examined and scored 1, 24, 48 and 72 hours after treatment and/or patch removal. Skin effects were scored for erythema and oedema, any other observations of changes to the skin was recorded.
For the intra-dermal application, 0.1 mL per concentration was injected intra-dermally into the hair free skin of the flanks. One concentration was injected on the right side and another concentration on the left side of the animals. Each concentration was injected in duplicate. Two animals were used per concentration.
It was found that concentrations of 0.5, 1, 2.5 and 5% (w/v) in saline produced no reaction (scores 0-0) in the skin of guinea pigs at the 1, 24, 48 and 72 hours
observation.
For the dermal application, approximately 0.5 mL per concentration was applied onto the clipped and shaved skin of the animals. A closed patch exposure was performed by means of an occlusive bandage using similar treatment procedures as for the main study. One concentration was used on the right side and another concentration on left side of the animals. Two animals were used per concentration. Time of exposure was 48 hours.
It was found that 0.5 ml of the test item formulations at concentrations of 100%v(undiluted), 75, 50 and 25% (w/v) produced no reaction (scores 0-0) on the skin of guinea pigs.
On the basis of results of the Preliminary Dose Range Finding Study, the 5% (w/v) concentration was used for intra-dermal treatment and 100% (undiluted) was used for dermal induction treatment.
Control animals were treated with saline.
For the challenge exposure, the 100% (undiluted) concentration was used as challenge dose and a concentration of 50% (w/v) as safeguard dose.
MAIN STUDY
A. INDUCTION EXPOSURE (2 phases)
Main Study I: Intra-dermal Induction Exposure
The day before the treatment, an area of 5 x 5 cm2 on the scapular region of animals was clipped free of hair and shaved.
Test group:
A series of three injections was administered on each side of the scapular region of treatment group animals, as follows, resulting in six injections per animal:
o 2 injections with 0.1 mL of Freund's Complete Adjuvant mixed with saline (1:1) (v/v),
o 2 injections with 0.10 mL of the test item in saline at 5% (w/v) concentration,
o 2 injections with 0.1 mL of test item in 5% (w/v), formulated in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and saline.
Control group:
The control animals were treated similarly as the test group; however, the vehicle without the test item was used for injections as follows:
o 2 injections with 0.1 mL mix of Freund's Complete Adjuvant and saline (1:1) (v/v),
o 2 injections with 0.1 mL of saline,
o 2 injections with 0.1 mL of 50% formulation of saline in a 1:1 mixture (v/v) of Freund's Complete Adjuvant and saline.
Main study II: Dermal Induction Exposure
The same inter-scapular region which received the intradermal injections, were used for dermal induction exposure.
Since the test item was not skin irritant in the Preliminary Dose Range Finding Study, the test area was painted with 0.5 mL of 10 % sodium dodecyl sulphate in Vaseline 24 h prior to the topical induction application, in order to create a local irritation.
Seven days after the intra-dermal injections, the same hair-free scapular area (approximately 6x8 cm) was treated. A 2.5x2.5 cm sterile gauze patch (4 layers of porous gauze pads) was saturated with approximately 0.5 mL of the test item at 100% (undiluted) concentration (the highest dose found non-irritant in the preliminary dose range finding study) and placed over the injection sites.
The control group was treated with 0.5 mL saline.
B. CHALLENGE EXPOSURE
Main study III: Challenge Exposure
Two weeks after the topical induction application, the animals were exposed to a dermal challenge dose. Approximately twenty four hours before the treatment, the hair was removed from an area of approximately 6x8 cm on the left and right flank of each animal. A 5x5 cm patch of sterile gauze patch was saturated with the test item at 100% (undiluted) concentration and applied to the left flank of all animals (both the test and the control). The right shaved flank area of all animals was treated with a 50% dilution of the maximum dermal challenge dose.
The volume of formulated test item was approximately 0.5 mL. Treatment was as indicated in point 3.5.2.2 (Closed Patch Test). The time of the exposure was 24 hours. After the patch removal any remaining test item was removed with a wet gauze swab
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
Results and discussion
- Positive control results:
- RELIABILITY STUDY
The sensitivity and reliability of the experimental procedure is assessed twice a year by use of items which are known to have moderate skin sensitisation properties such as 2-Mercaptobenzothiazole (OECD 406, adopted 17 July 1992 chapter 10., 11.).
The results of the latest reliability check (Study Code: 14/416-104T) are summarised here below.
START OF EXPERIMENT : 07 October 2014
END OF EXPERIMENT : 31 October 2014
FINAL REPORT : 17 December 2014
The selection of dose levels was made on the basis of the previous reliability study.
Intra-dermal induction exposure: 1% (w/v)
Dermal induction exposure: 75% (w/v)
Challenge treatment: 50% (w/v)
SUMMARY OF THE RELIABILITY STUDY
Challenge with reference item 2-Mercaptobenzothiazole resulted in a positive response in test animals previously sensitised. The net response values at the 24 and 48 hours observations represented an incidence rate of 90% and 80% and net score values of 0.90 and 0.80 respectively. In the control animals no visible changes were found either at the 24 or 48 hours examinations following challenge with the
reference item.
The dermal scores represented discrete erythema (score 1) developed on the skin of sensitised guinea pigs.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 0.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 0.0.
Any other information on results incl. tables
OBSERVATIONS DURING INDUCTION and CHALLENGE PHASE
|
N° animal |
Induction phase |
Challenge phase |
||||||||||||
Day 2 |
Day 10 |
Day 11 |
Day 12 |
Day 13 |
Day 24 |
Day 25 |
|||||||||
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
||
Control |
117 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
128 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
131 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
133 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
137 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Treated |
118 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
120 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
126 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
127 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
134 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
135 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
136 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
138 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
139 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
140 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
O: Oedema
E: Erythema
0: No erythema or Oedema
1: Very slight erythema (Barely perceptible)
BODY WEIGHT
|
N° Animal |
Day -1 |
Day 7 |
Day 14 |
Day 21 |
Day 25 |
Control |
117 |
501 |
523 |
541 |
555 |
584 |
128 |
483 |
501 |
515 |
531 |
556 |
|
131 |
495 |
498 |
556 |
565 |
591 |
|
133 |
481 |
520 |
559 |
552 |
574 |
|
137 |
464 |
467 |
502 |
501 |
510 |
|
Mean |
484.4 |
501.8 |
534.6 |
540.8 |
563.0 |
|
Standard Deviation |
14.3 |
22.4 |
25.2 |
25.5 |
32.4 |
|
Treated |
118 |
484 |
499 |
530 |
557 |
541 |
120 |
503 |
493 |
554 |
576 |
579 |
|
126 |
503 |
517 |
557 |
598 |
614 |
|
127 |
467 |
512 |
551 |
598 |
583 |
|
134 |
465 |
487 |
530 |
557 |
561 |
|
135 |
489 |
512 |
517 |
551 |
547 |
|
136 |
479 |
526 |
516 |
550 |
542 |
|
138 |
474 |
515 |
546 |
580 |
592 |
|
139 |
492 |
530 |
536 |
583 |
567 |
|
140 |
487 |
517 |
546 |
574 |
580 |
|
Mean |
484.3 |
510.8 |
538.3 |
572.4 |
570.6 |
|
Standard Deviation |
13.3 |
13.8 |
14.8 |
18.0 |
23.6 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Challenge with test item DP1268 evoked no positive responses in the test animals previously sensitised with the test item or in the control group. The net response value represented an incidence rate of 0 % and the net score value of 0.00.
In conclusion, under the conditions of the present assay the test item DP1268 was shown to have no sensitisation potential and classified as a non-sensitizer - Executive summary:
The sensitising potential of DP 1268 was investigated in a guinea pig maximization test comparable to standard conditions of the OECD Guideline 406.
Intradermal induction was performed with a test concentration of 5% followed by a 48-hour occlusive patch with 100% DP 1268 seven days later. After a 14-day interval, challenge was performed by application of an occlusive chamber with 100% DP 1268 to a prepared flank for 24 hrs.
No sensitzing activity of DP 1268 was indicated in the guinea pig maximization test.
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