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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 269-412-8 | CAS number: 68238-92-6
- 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
- Remarks:
- source of read across
- Adequacy of study:
- key study
- Study period:
- From September 13 to October 21, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted on July 17, 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test performed on 1999.
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414 Füllinsdorf / Switzerland.
- Age at study initiation: 4 - 6 weeks.
- Weight at study initiation: pretest groups 354 - 405 g; body weight at beginning of acclimatization period control and test group 309 - 398 g.
- Housing: individually in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: pelleted standard Nafag Ecosan 845 25W4, batch no.79/99, guinea pig breeding / maintenance diet ("Nafag", Näihr- und Futtermittel AG, CH-9202 Gossau), ad libitum.
- Water: community tap water from Füllinsdorf, ad libitum.
- Acclimation period: one week for the control and test group under test conditions after health examination. No acclimatization for the animals of the pretest. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Relative humidity: 40 - 70 %
- Air changes: 10-15 air changes per hour.
- Photoperiod: automatically controlled light cycle of 12 hours light and 12 hours dark. Fluorescent "Gold" lamps (Silvania Gold F40T1260) were present in the room used for the study. Music was played during the light period.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5 %
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50 %
- Day(s)/duration:
- 2
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 10 %
- Day(s)/duration:
- 1
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Control group: 5 males
Test group: 10 males - Details on study design:
- RANGE FINDING TESTS
- No of animals per dose: 1 animal intradermal pretest and 2 animals epidermal pretest.
INTRADERMAL INJECTIONS
Four intradermal injections (0.1 ml/site) of a 1:1 (v/v) mixture of Freund's Complete Adjuvant/physiological saline were made into the shaved neck of one guinea pig. One week later intradermal injections (0.1 ml/site) were made into the clipped flank of the same guinea pig at concentrations of 5, 3 and 1 % of the test article in bi-distilled water.
Dermal reactions were assessed 24 hours later. Based on the results, a test article concentration of 5 % was selected for intradermal induction in the main study.
EPIDERMAL APPLICATIONS
4 patches of filter paper (3 x 3 cm) were saturated with the test article at 50 % (this concentration was found to be the maximum possible under the conditions of the procedure), 25 %, 15 % and 10 % in bi-distilled water and applied to the clipped and shaved flanks. The amount of test article preparation applied was approximately 0.2 g for the test article at 50 Vo and a volume of approximately 0.2 ml was applied for the remaining test article concentrations. The patches were covered by a strip of aluminum foil and firmly secured by elastic plaster wrapped around the trunk and covered with impervious adhesive tape. This procedure ensured the intensive contact of the test article. The dressings were removed after an exposure period of 24 hours.
Twenty-one hours after removal of the dressing the application site was depilated with an approved depilatory cream in order to visualize any resulting erythema.
The depilatory cream was placed on the patch sites and surrounding areas, and left on for 3-5 minutes. It was then thoroughly washed off with a stream of warm, running water.
Thereafter, the animals were dried with a disposable towel, and returned to their cages. The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema according to the method of Magnusson and Kligman.
MAIN STUDY
INTRADERMAL INJECTIONS / PERFORMED ON TEST DAY 1
An area of dorsal skin from the scapular region (approximately 6 x 8 cm) was clipped free of hair. Three pairs of intradermal injections (0.1 ml/site) were made at the border of a 4 x 6 cm area in the clipped region as follows:
Test Group:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) The test article, at 5 % in bidistilled water.
3) The test article at 5 % in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
Control Group:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) Bi-distilled water
3) 1:1 (w/w) mixture of bi-distilled water in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
EPIDERMAL APPLICATIONS / PERFORMED ON TEST DAY 8
One week after the injections, the scapular area (approximately 6 x 8 cm) was again clipped and shaved free of hair prior to the application. A 2 x 4 cm patch of filter paper was saturated with the test article (50 % in bi-distilled water) and placed over the injection sites of the test animals. The amount of test article preparation applied was approximately 0.3 g. The patch was covered with aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The occlusive dressings were left in place for 48 hours. The epidermal application procedure described ensures intensive contact of the test article.
The guinea pigs of the control group were treated as described above with bi-distilled water only, applied at a volume of approximately 0.3 ml.
The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema according to the method of Magnusson and Kligman.
B. CHALLENGE EXPOSURE
CHALLENGE / PERFORMED ON TEST DAY 22
The test and control guinea pigs were challenged two weeks after the epidermal induction application and were treated in the same way.
Hair was clipped and shaved from a 5 x 5 cm area on the left and right flank of each guinea pig just prior to the application. Two patches (3 x 3 cm) of filter paper were saturated with the test article at the highest non-irritating concentration of 10 % (left flank) and the vehicle only (bi-distilled water applied to the right flank) using the same method as for the epidermal application. The volume of test article preparation and vehicle applied was approximately 0.2 ml. The dressings were left in place for 24 hours.
Twenty-one hours after removal of the dressing the test sites treated with the test article were depilated as described in the epidermal pretest.
The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema according to the method of Magnusson and Kligman.
OBSERVATIONS
- Viability / Mortality: daily from delivery of the animals to the termination of the test.
- Clinical signs (local/systemic): daily from delivery of the animals to the termination of the test.
- Skin reactions: at the times specified during the pretest, induction and challenge periods.
- Body weights: at pretest and acclimatization start, day I and termination of the test. - Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- -
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
Any other information on results incl. tables
SKIN EFFECTS AFTER EPIDERMAL INDUCTION PERFORMED ON TEST DAY 8
CONTROL GROUP: no erythematous or oedematous reaction was observed in the animals treated with bi-distilled water only.
TEST GROUP: as the test article at 50 % stained the skin red-brown, it was not possible to determine whether erythema was present or not. However, no oedema was observed.
SKIN EFFECTS AFTER THE CHALLENGE PERFORMED ON TEST DAY 22
CONTROL GROUP: no skin reactions were observed in the animals when treated with either bi-distilled water only or when treated with the test article at l0 % in bi-distilled water. Red-brown discoloration was noted directly after removal of the patch. To remove the discoloration all animals were depilated 3 hours prior to challenge reading.
TEST GROUP: discrete/patchy to moderate/confluent erythema were observed in five out of 10 animals at the 24- and 48-hour reading after treatment with the test article at l0 % in bi-distilled water. No skin reactions were observed in the animals when treated with bi-distilled water only. Red-brown discoloration was noted directly after removal of the patch.
After 24 hrs | After 48 hrs | |||
positive / total | % positive of total | positive / total | % positive of total | |
Control group |
||||
Test item 10 % in bi-distilled water | 0 / 5 | 0 | 0 / 5 | 0 |
Bi-distilled water only | 0 / 5 | 0 | 0 / 5 | 0 |
Test group |
||||
Test item 10 % in bi-distilled water | 5 / 10 | 50 | 5 / 10 | 50 |
Bi-distilled water only | 0 / 10 | 0 | 0 / 10 | 0 |
VIABILITY / MORTALITY / MACROSCOPIC FINDINGS
There were no deaths during the course of the study, hence no necropsies were performed.
CLINICAL SIGNS, SYSTEMIC
No signs of systemic toxicity were observed in the animals.
BODY WEIGHTS
Animal no. 982 of the test group showed a loss of body weight during the acclimatization period. It recovered between the treatment start and the end of the study.
The body weight of the other animals was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Sens 1B (H317), according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Skin sensitizer
- Executive summary:
In order to assess the cutaneous allergenic potential of test item, the 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 sensitization in the test group was performed in the nuchal region with a 5 % dilution of the test article in bi-distilled water and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test article at 50 % in bidistilled water one week after the intradermal induction. The animals of the control group were intradermally induced with bi-distilled water and FCA/physiological saline and epidermally induced with bi-distilled water under occlusion.
Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test article at 10 % in bi-distilled water and bi-distilled water alone under occlusive dressing.
Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.
No toxic symptoms were evident in the guinea pigs of the control or test group. No deaths occurred. Five out of 10 test animals showed discrete/patchy to moderate/confluent erythema after the challenge treatment with test item at 10 % (wlw) in bi-distilled water. No skin effect was observed in the control group.
Conclusion
Based on the above mentioned findings in an adjuvant sensitization test in guinea pigs and in accordance to CLP Regulation (EC) No 1272/2008 has to be classified and labelled as a skin sensitizer, category 1B.
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.