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EC number: 701-396-4 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 May - 27 July 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- / the test group consisted of 5 instead of 10 animals; Titermax was used as adjuvants; grading scale differs from OECD 406, limited data on test article given (expiration date, purity, storage)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Deviations:
- yes
- Remarks:
- / the test group consisted of 5 instead of 10 animals; Titermax was used as adjuvants; grading scale differs from OECD 406, limited data on test article given (expiration date, purity, storage)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted in 2002, where no validated protocol for the LLNA was available.
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- SPF Hartley guinea pig Aai: (HA) Outbred
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Microbiological status of animals: Animals were checked for respiratory or intestinal disease, skin eruptions, mucosal membrane irritation, postural difficulties and general condition.
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 386 - 423 g (Test group) 368 - 419 g (Control group)
- Housing: animals were housed in stainless steel cages (no further information available)
- Diet: Lab Diet Certified Guinea Pig Diet (#5026), ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6 - 29.4
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/ 12
- IN-LIFE DATES: From: 21 May To: 27 July 2002
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% (v/v)
0.1 mL/ injection site
positive control: 25% - Day(s)/duration:
- single injection
- Adequacy of induction:
- other: The test substance did not exhibit skin irritating properties in the screening test. Thus, undiluted test substance was used for intradermal injection.
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 % (v/v)
2 x 4 cm patch spread with 0.5 mL - Day(s)/duration:
- 48 h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
0.4 mL applied via 25 mm Hilltop Chamber - Day(s)/duration:
- 1
- Adequacy of challenge:
- other: non-irritant concentration
- No. of animals per dose:
- 3 males and 2 females (main test)
2 males and 2 females (epicutaneous pretest)
1 male (intradermal pretest) - Details on study design:
- RANGE FINDING TESTS:
- intradermal injections:
site 1: 5% test substance (50/50 emulsion of TiterMax (TM) and distilled water)
site 2: 100%
site 3: 50% test substance (in distilled water)
Injections (0.1 mL of each) were made between shaved shoulder blades of one guinea pig.
- epidermal applications: 10, 25, 50 and 100 % (in distilled water). 0.4 mL of the test article were applied to close-clipped trunks of each of four guinea pigs via a 25 mm Hilltop Chamber (with the cotton patch). An elastic tape (Elastoplast, Beiersdorf Inc., Norwalk, USA) was wrapped around the animal, which was lined to pure latex dental dam (HCM - Hygienic Corporation, Malaysia). After 24 h, dressings were removed. The remaining test substance was wiped away with ethanol 45 h after application. Skin reactions were evaluated 3 and 24 h after the removal of the test substance.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: 1:1 mixture (v/v) TM/ distilled water
Injection 2: 100 % test substance
Injection 3: 100 % test substance, emulsified in a 1:1 mixture (v/v) TM/ distilled water
Epicutaneous:
100% test substance
- Control group: was not co-treated during induction phase
- Site: shoulder area (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: days 0 - 9
- Concentrations: 100% (intradermal + epicutaneous)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: 24 h
- Test groups: test substance and positive control substance
- Control group: 100% test substance
- Site: shaved flank of respective animal
- Concentrations: 100%
- Evaluation (hr after challenge): 48, 72 and 96 h - Challenge controls:
- the control group is actually a challenge control
- Positive control substance(s):
- yes
- Remarks:
- 1 -Chloro-2,4-Dinitrobenzene, Lot# 100K1323
Results and discussion
- Positive control results:
- 1-Chloro-2,4-Dinitrobenzene was used as positive control substance in the study. For intradermal induction, the following injetions were made:
site 1: TiterMax®/ distilled water (1:1)
site 2: 5% test substance (in corn oil)
site 3: 1% test substance (in TiterMax®/ distilled water emulsion (1:1))
On day 7, 25% 1-Chloro-2,4-Dinitrobenzene solved in petrolium jelly was applied for epidermal induction. For challenge, 0.05% 1-Chloro-2,4-Dinitrobenzene dissolved in pertoleum jelly was applied.
At the 48 h reading time point, 4/5 animals revealed erythema graded with 1 (3/4 animals, very slight erythema) or 2 (1/4 animals, well-defined erythema). 24 h later, erythema were still visible in all 4 animals scored with grade 1 (very slight erythema). Very slight erythema (scored with grade 1) and questionable erythema were observed in 1/5 and 3/5 animals at the 72 h reading time point, respectively. No edema were observed.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- intradermal induction: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal induction: 100% challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Animals were treated with a 10 % Sodium-Lauryl-Sulphate solution 24 h prior to the epicutaneous induction.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- intradermal induction: 5% challenge: 0.05%
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Remarks on result:
- other: One additional animal showed a questionable erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- intradermal induction: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- intradermal induction: 100% challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Animals were treated with a 10 % Sodium-Lauryl-Sulphate solution 24 h prior to the epicutaneous induction.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- intradermal induction: 5%; challenge: 0.05%
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Reading:
- other: 3rd reading
- Hours after challenge:
- 96
- Group:
- negative control
- Dose level:
- intradermal induction: 0% challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 96
- Group:
- test chemical
- Dose level:
- intradermal induction: 100% challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Animals were treated with a 10 % Sodium-Lauryl-Sulphate solution 24 h prior to the epicutaneous induction.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 96
- Group:
- positive control
- Dose level:
- intradermal induction: 5% challenge: 0.05%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Remarks on result:
- other: 3 additional animals showed questionable erythema.
Any other information on results incl. tables
Pre-tests
Intradermal injection
1 male was injected with 100 µL of the test substance per test site as follows:
Site Dosage
1 5% in a 50/50 emulsion of TiterMax® and distilled water
2 100% (undiluted)
3 50% in distilled water
Table 1: Intradermal injection
Animal No. |
Sex |
Test site |
Concentration [%] |
Score after 24 h |
Score after 48 h |
||
Erythema |
Oedema |
Erythema |
Oedema |
||||
1 |
M |
1 |
5 |
2 |
1 |
2 |
1 |
2 |
100 |
0 |
0 |
0 |
0 |
||
3 |
50 |
1 |
0 |
0 |
0 |
Epicutaneous application
4 animals (2 males/2 females) were treated with different concentrations (10, 25, 50, 100% in distilled water) of the test substance. At the 48 h reading time point, 2 males showed a questionable erythema at skin areas treated with 50 and 100% test substance. In one male, the questionable erythema was still visible 24 h later (72 h reading time points) at both concentrations. There were no effects (oedema or erythema) visible in the other animals or using the other 2 concentrations, neither at the 48 nor after 72 reading time point.
Table 2: Body weights summary
|
|
Initial weight [g] |
Terminal weight [g] |
Test group |
M |
400 |
519 |
388 |
466 |
||
423 |
519 |
||
F |
386 |
464 |
|
404 |
497 |
||
Control group |
M |
386 |
524 |
393 |
514 |
||
386 |
466 |
||
F |
419 |
529 |
|
368 |
514 |
||
Test group (Positive control) |
M |
442 |
518 |
402 |
541 |
||
450 |
580 |
||
F |
384 |
504 |
|
392 |
498 |
||
Control group (Positive control) |
M |
420 |
556 |
386 |
554 |
||
360 |
498 |
||
F |
430 |
562 |
|
436 |
560 |
The body weight gain of the the animals was not affected adversely during the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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.
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