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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 434-070-2 | CAS number: 268567-32-4
- 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
The substance caused skin sensitization in guinea pigs as determined in a GLP-compliant study according to OECD testing guideline 406. No data on respiratory sensitization are available.
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:
- 9-NOV-1999 - 20-DEC-1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1993)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in 2000, when the GPMT was an international accepted and recommended method to assess sensitizing potential.
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under test conditions: Stable in PEG 400 and in a 1:1 (v/v) mixture of FCA/physiological saline for at least 2 h - Species:
- guinea pig
- Strain:
- other: Ibm: GOHI; SPF-quality
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd. Biotechnology & Animal Breeding Division, CH-4414 Füllinsdorf / Switzerland.
- Age at study initiation: 5 - 7 weeks.
- Weight at study initiation: 337 - 371 g.
- Housing: individually in Makrolon type-4cages.
- Diet: pelleted standard Nafag Ecosan 845 25W4, guinea pig breeding/maintenance diet (containing Vitamin C), ad libitum.
- Water: tap water, ad libitum.
- Acclimation period: 1 week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 50 %
- Day(s)/duration:
- day 0
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.3 mL; 100 %
- Day(s)/duration:
- day 8 / 48 h
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 50 %
- Day(s)/duration:
- day 21 / 24 h
- No. of animals per dose:
- Pretest: 3 animals.
Main test: 10 animals in treatment group, 5 animals in control group. - Details on study design:
- RANGE FINDING TESTS:
Pretest:
Intradermal Injection:
Four intradermal injections (0.1 mL/site) of a 1:1 mixture of FCA/physiological saline were made in the shaved neck of one guinea pig. One week later intradermal injection (0.1 mL/site) was made into the clipped flank of the same guinea pig at concentrations of 100 %, 75 % and 50 % of the test article in PEG 400. Dermal reactions were assessed 24 h later. Based on the results a concentration of 50 % was selected for intradermal induction in the main study.
Epidermal Application:
Four intradermal injections (0.1 ml/site) of a 1:1 mixture of FCA/physiological saline were made in the shaved neck of two guinea pigs. One week later, 4 patches were saturated with the test article at concentrations of 100 %, 75 %, 50 % and 25 % in PEG 400, respectively. The patches were applied to the clipped and shaved flanks of each of the two animals under occlusive conditions. The exposure period was 24 h. After removal of the patches the skin was examined for signs of irritation.
According to results of the pretest for intradermal injection (induction) in the main study a concentration of 50 % of test article in vehicle was selected. Undiluted (100 %) test article was selected for epidermal induction, and 50 % in vehicle for epidermal challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2;
Intradermal: three pairs of intradermal injections (1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline, the test article, at 50 % in PEG 400 and the test article at 50 % in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline; 0.1 mL/site)
Epidermal: undiluted test article one week after intradermal injections.
- Exposure period: epidermal application was performed for 48 h.
- Test groups: 10 males.
- Control group: 5 males.
- Site: dorsal skin from the scapular region.
B. CHALLENGE EXPOSURE (TWO WEEKS AFTER INDUCTION)
- No. of exposures: 1.
- Day(s) of challenge: 1.
- Exposure period: 24 h.
- Test groups: 10 males.
- Control group: 5 males.
- Site: flank.
- Concentrations: 50 % test article in vehicle.
- Evaluation (hr after challenge): approximately 25 and 48 hours after challenge. - Challenge controls:
- PEG 400
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole (independently performed, report attached)
- Positive control results:
- Validation of sensitivity of the Maximization-Test was performed from 1998-12-01 to 1999-01-08 (RCC Project 903407). In accordance to OECD 406, 2-Mercaptobenzothiazole was selected as a positive control. The intradermal induction of sensitization was performed with a 5 % dilution of the test article in mineral oil and in an emulsion of FCA/physiological saline. The epidermal induction of sensitization was conducted under occlusion with the test article at 50 % in mineral oil. Two weeks after the epidermal induction application the challenge was completed by epidermal application of the test article at 10 % in mineral oil under occlusive dressing. The animals of the control group were induced with mineral oil and FCA/physiological saline and challenged similarly to those of the test group. Cutaneous reactions, i.e. erythema and eschar, as well as edema formation were evaluated at 24 and 48 hours after removal of the dressing.
90 % (at the 24-hour reading) and 100 % (at the 48-hour reading) of the animals of the test group were observed with very slight to moderate/severe erythematous reactions after treatment with a non-irritant test article concentration of 10 % in mineral oil. No skin reactions were observed in the control group. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no skin irritations were observed
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- positive reactions consisted of discrete/patchy to intense erythema and swelling of the skin
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no skin irritations were observed
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- positive reactions consisted of discrete/patchy to moderate/confluent erythema
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
Reference
Details on skin reactions after the challenge procedure
Reading time point |
24 h |
48 h |
||||
|
positive |
total |
% positive of total |
positive |
total |
% positive total |
Control group (induced without test article) |
||||||
challenged with the test item 50 % in PEG 400 |
0 |
5 |
0 |
0 |
5 |
0 |
challenged with PEG 400 |
0 |
5 |
0 |
0 |
5 |
0 |
Test group (induced with test article) |
||||||
challenged with the test item 50 % in PEG 400 |
7 |
10 |
70 |
7 |
10 |
70 |
challenged with PEG 400 |
0 |
10 |
0 |
0 |
10 |
0 |
Remark:
No toxic symptoms and no mortality were observed in the animals.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
In order to assess the cutaneous allergenic potential, a Maximization-Test was performed in 15 (10 test and 5 control) male albino guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 96/54/EEC, B.6. The intradermal induction of sensitisation in the test group was performed in the nuchal region with a 50 % dilution of the test article in PEG 400 and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitisation was conducted for 48 hours under occlusion with the undiluted test article one week after the intradermal induction. The animals of the control group were intradermally induced with PEG 400 and FCA/physiological saline and epidermally induced with PEG 400 under occlusion. Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test article at 50 % in PEG 400 and PEG 400 alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. Seven out of 10 test animals showed discrete/patchy to intense erythema and swelling (at the 24-hour reading) and discrete/patchy to moderate/confluent erythema (at the 48-hour reading) after the challenge treatment at 50 % (w/w) in PEG 400. No skin effect was observed in the control group.
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 1272/2008. As a result the substance is considered to be classified for skin sensitization in category 1B under Regulation (EC) No. 1272/2008.
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.