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EC number: 603-923-2 | CAS number: 135590-91-9
- 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 (OECD 406, GPMT): not sensitising
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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Principles of method if other than guideline:
- Chemical substances may sensitise after single or repeated dermal application. Further application after the elapse of a certain period may cause allergic reactions. If this sensitisation occurs not after application of the test substance alone, but only in the presence of sufficient luminous energy, this is a so-called "photoallergic reaction". "Photoallergy" is defined as an increased reactivity of the skin to ultraviolett and/or visible radiation caused by an immunologic reaction to a chemical agent.
- GLP compliance:
- yes
- Type of study:
- other: photosensitisation test
- Justification for non-LLNA method:
- The test was performed in 1995 before the alternative OECD guidelines (LLNA and in vitro test methods) were set into force.
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 307 g mean
- Housing: in fully air-conditioned rooms in Makrolon cages (Type 4) on soft wood granulate, in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 3112 for guinea pigs and rabbits ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- epicutaneous, open
- Vehicle:
- other: DAE (dimethylacetamid : acetone : ethanol, 40 : 30 : 30)
- Concentration / amount:
- induction: 0.1%
- Route:
- epicutaneous, open
- Vehicle:
- other: DAE (dimethylacetamid : acetone : ethanol, 40 : 30 : 30)
- Concentration / amount:
- challenge: 0.1%
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 12
- Test groups: Test substance in solvent + 7min h*v (week 1 UVA/vis >315 nm; week 2/3 UVA/B/vis >300 nm), single application of FCA at beginning of week 2
- Control group: solvent + 7min h*v (week 1 UVA/vis >315 nm; week 2/3 UVA/B/vis >300 nm), single application of FCA at beginning of week 2
- Site: front part of shaven dorsal skin
- Frequency of applications: 4/week
- Duration: day 1 - 18
- Concentrations: 0.1 %
B. CHALLENGE EXPOSURE
- No. of exposures: 3
- Day(s) of challenge: 35, 36, 37
- Test groups: Test substance + 2 min h*ν (UVA/B/vis >300 nm)
- Control group: Test substance + 2 min h*ν (UVA/B/vis >300 nm)
- Site: rear part of the dorsal skin
- Concentrations: 0.1 %
- Evaluation (hr after challenge): Macroscopic examination of the skin 24 h after each challenge application
OTHER:
The formation of dermal reactions, such as erythema, oedema and scab formation are major clinical indications of photoallergy or contact allergy. The decisive criterion for evaluation of the photoallergic properties of a test substance is the number of sensitised test animals. The substance is considered to be photosensitising if 30 % or more of the animals treated with the the test substance show a positive reaction and at the same time no irritant effects have emerged in the negative control group.
At the end of the study the animals were weighed and sacrificed by carbon dioxide asphyxiation. - Positive control substance(s):
- yes
- Remarks:
- chlorpromazine
- Positive control results:
- During the induction phase the animals in the positive control group showed slight to well defined erythema and a number of local dermal findings.
The challenge treatment caused slight to well defined erythema in all animals and slight to moderate oedema in 90 % of the animals in the positive control group.
In the positive control all animals showed erythema and 90 % showed oedema - Reading:
- other: 1st challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 1st challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 2nd challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 2nd challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 3rd challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 1st challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 1st challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 2nd challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 2nd challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 3rd challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 1st challenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 % chlorpromazine
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- very slight to well-defined erythema and very slight oedema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 1st challenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 % chlorpromazine. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: very slight to well-defined erythema and very slight oedema.
- Reading:
- other: 2nd challenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 % chlorpromazine
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- very slight to moderate/severe erythema and very slight oedema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 2nd challenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 % chlorpromazine. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: very slight to moderate/severe erythema and very slight oedema.
- Reading:
- other: 3rd challenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 % chlorpromazine
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- very slight to moderate/severe erythema and very slight to well-defined oedema; dry rough skin, fine scales, indurations, scabbed skin
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 3rd challenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 % chlorpromazine. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: very slight to moderate/severe erythema and very slight to well-defined oedema; dry rough skin, fine scales, indurations, scabbed skin.
- Interpretation of results:
- other: not photosensitising
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed in 1991 before the alternative OECD guidelines (LLNA and in vitro test methods) were set into force.
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Age at study initiation: about 4 weeks
- Weight at study initiation: 262.4 g mean
- Housing: in fully air-conditioned rooms in Makrolon cages (Type 4) on soft wood granulate, in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 3112 for guinea pigs and rabbits, ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Intradermal induction: 5 %
Epicutaneous induction: 25% - Day(s)/duration:
- 48 h (epicutaneous)
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 25%
- Day(s)/duration:
- 24 h
- No. of animals per dose:
- 20 (in test groups), 10 (controls)
- Details on study design:
- RANGE FINDING TESTS:
In a dermal-occlusive test for primary skin irritation, 25, 5 and 1% in paraffin were applied to the left flank of two guinea pigs. The hair on the right and left flanks of the animals was removed mechanically. 0.5 mL of the test substance preparation was applied to a 2 x 2 cm cellulose
patch, which was then fixed to the left flank and covered occlusively for 24 hours with a bandage and film. 24 hours after removal of the patches, the treated skin areas were examined for erythema and oedema.
No irritation occurred after application of any of the tested concentrations.
For this reason the 25% concentration was selected for the main study.
To determine the tolerance of intradermal injections, each of the following preparations was administered twice by intradermal injection to 3 guinea pigs. The injection sites (sites 1, 2 and 3) were all within a dorsal area measuring 2 x 4 cm in the vicinity of the shoulder.
Site 1: 2 x 0.1 ml 5.0% in paraffin
Site 2: 2 x 0.1 ml 1.0% in paraffin
Site 3: 2 x 0.1 ml 0.2% in paraffin
The injections with the 5% substance preparation in paraffin caused very slight to well-defined erythema and slight oedema. The injection sites for the 1% and 0.2% preparations showed very slight to well-defined erythema and (very) slight oedema.
Based on this preliminary test, the 5% preparation in paraffin was selected for the intradermal injections in the main test.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal day 1 and epicutaneously day 8)
- Test groups: Intradermal: 50% Freund's adjuvant alone, test substance in paraffin, test substance in 50% Freund's adjuvant; epicutaneous: test substance in paraffin
- Control group: Intradermal: 50% Freund's adjuvant alone, paraffin only, 50% Freund's adjuvant alone; epicutaneous: paraffin only
- Site: dorsal area 4 x 6 cm in the vicinity of the shoulders.
- Frequency of applications: 7 days
- Duration: day 1 to day 8
- Concentrations: Intradermal 5% test substance, epicutaneous 25 % test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Test groups: test substance epicutaneously
- Control group: test substance epicutaneously
- Site: shaved left flank, shaved right flank remained untreated
- Concentrations: 25% test substance
- Evaluation (hr after challenge): 48 and 72 - Challenge controls:
- The control group actually is a challenge control.
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 5% intradermal, 25% epicutaneous; challenge: 25% epicutaneous
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction: 5% intradermal, 25% epicutaneous; challenge: 25% epicutaneous
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema, dry rough skin, fine scales
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- CLP: Not classified
Referenceopen allclose all
No clinical signs of intoxication were observed at any time during the study. There were no impairements of body weight gains.
During the induction phase from weeks 1 to 3 in both the control and treatment groups slight to moderate erythema were recorded. The challenge treatment caused no dermal irritation in both the control and treatment groups.
Based on the results of this study the test substance has no photosensitising potential.
The treated animals showed no clinical signs of intoxication at any time during the study. The intradermal injections with Freund's adjuvant (with and without test substance) caused moderate oedema, well-defined to moderate erythema. The injection site revealed white discoloured areas, and the skin was encrusted and scabbed. After dermal induction treatment the tissue of these injection sites became necrotic or developed open wounds in the control as well as in the treatment group. The body weight gains of the treated animals were not impaired.
Challenge:
48 and 72 hours after removal of the occlusive bandage, 4 out of 20 animals in the treated group (20%) showed dermal reactions in the form of very slight erythema, whereas no signs of dermal irritation were noticed in the control group. Additionally the skin surface was dry, rough and covered with fine scales.
Conclusion:
Based on the results of this study, Hoe 107892 00 ZC97 0001 is non-sensitising, and thus not subject to labelling requirements according to the criteria for classification in Directive 83/467/EEC.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A GPMT assay analysing the skin sensitising properties of the test item was conducted according to OECD guideline 406 and compliant with GLP.
Twenty female Pirbright-Hartley guinea pigs were induced intradermally with 5% test substance formulated in paraffin on study Day 1 and epicutaneously with 25% test substance formulated in paraffin on study Day 8. After 48 h of exposure under occlusive conditions, the patch was removed.
Three weeks later, the challenge was performed. The animals were epicutaneously treated with 25% test substance and exposed for 24 h under occlusive conditions. A similar constituted group of control animals was induced but remained untreated during the challenge.
Skin reactions were evaluated 48 and 72 h after removal of the test substance. At the first reading 48 h after challenge 4/20 (i.e. 20 %) of the test animals showed very slight erythema. At the second reading 72 h after the challenge, 3/20 (i.e. 15%) animals showed very slight erythema, dry rough skin and fine scales. Based on the results of the study, the test item is not considered to be a skin sensitiser.
Additionally, a test for photosensitisation was reported, in which the ability to increase the reactivity of the skin to UV and/or visible radiation caused by sensitisation to the test substance was assessed. In this test none of the 10 test animals showed positive reactions at the readings 24 hours after first, second and third challenge.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP) and are therefore conclusive but not sufficient for classification.
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