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EC number: 923-144-4 | CAS number: 1182722-58-2
- 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
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:
- from February to March 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported GLP Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Sex: 17 females
- Source: Harlan Winkelmann GmbH Laboratory Animal Breeders; 33176 Borchen
- Age at study initiation: 3 - 5 weeks
- Weight at study initiation: 290 -325 g
- Housing: 5 per cage (adaptation period); 2 - 3 per cage (study period)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40 - 60
- Air changes (per hr): >= 10 times
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: polyethylene glycol 400
- Concentration / amount:
- Intradermal induction: 5 % (= 20 mg test substance/animal)
Topical induction: 25% (= 125 mg test substance/animal)
Challenge: 25% (= 125 mg test substance/animal) - Route:
- epicutaneous, occlusive
- Vehicle:
- other: polyethylene glycol 400
- Concentration / amount:
- Intradermal induction: 5 % (= 20 mg test substance/animal)
Topical induction: 25% (= 125 mg test substance/animal)
Challenge: 25% (= 125 mg test substance/animal) - No. of animals per dose:
- control group: 10
test substance group: 20
dose range-finding groups: 1 (for intracuteneous induction), 4 (for topical indiction), 5 (for challenge) - Details on study design:
- RANGE FINDING TESTS:
Dose-range finding study for intradermal induction:
One guinea pig (animal No.1) was given intradermal injections twice, in each case, with 0.1 ml of the following test item concentrations: 0%, 1 %, 2.5 and 5%.
The injection sites were evaluated after 24 and 48 hours: Animal no. 1: 0%, 1 %, 2.5% and 5%: grey wheal with red surrounding after 24 and 48 hours.
Dose range-finding study for topical induction:
Three different concentrations (6%; 12%; 25%) and the vehicle (0%) were tested in each case on four guinea pigs. The patches moistened with 0.5 ml of the test item formulations or the vehicle were applied to each animal under occlusive conditions for 24 hours. At the end of the exposure period, the remaining test item or the vehicle were removed with physiological saline solution and twenty-one hours later the treated areas were shorn. The skin reactions were evaluated 48 hours and 72 hours after the start of the application. No animal of the test item groups and the control group exhibited a skin reaction.
Dose range-finding study for challenge:
One week prior to the challenge, the challenge concentration was determined on 2 guinea pigs in the main study that were treated in the same manner as the control animals during the inductions. Four patches each loaded with 0.5 ml test item formulation (6%; 12%; 25%) or the vehicle (0%) were applied to each animal under occlusive conditions for 24 hours. At the end of the exposure period, the remaining test item was removed with physiological saline solution and twenty-one hours later the treated areas were shorn. The skin reactions were evaluated 48 hours and 72 hours after the start of the application. No animal of the test item groups and the control group exhibited a skin reaction.
MAIN STUDY
A. INDUCTION EXPOSURE (intradermal followed by topical induction one week after the intradermal induction)
- No. of exposures: three injections on each site
- Test groups: three
- Control group: three
- Site: on the left an the right side of the spinal column
- Frequency of applications: once
- Duration: injection sites were visually assessed 2 and 7 days after the injection.
- Concentrations: 5% (intradermal); 25% (topical)
B. CHALLENGE EXPOSURE
- No. of exposures: once
- Day(s) of challenge: three weeks after intradermal induction
- Exposure period: 24 hours
- Test groups: 1 (10 animals)
- Control group: 1 (5 animals)
- Site: dorsal region of the left flank
- Concentrations: 25%
- Evaluation (hr after challenge): 21 hours after removal of the test item - Positive control substance(s):
- not required
- Remarks:
- Using 2-mercaptobenzothiazole the methodological reliability and the sensitivity of the strain are verified separately at regular intervals.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
To determine the skin-sensitizing properties of the test substance the guinea pig maximization test was performed on female guinea pigs according to OECD guideline 406. The study was conducted with the following test substance concentrations:
intradermal induction: 5%
topical induction: 25%
challenge: 25%
The test substance was formulated in polyethylene glycol 400 to yield a suspension. The challenge using a 25% test item formulation led to no skin effects in the animals in the treatment group and to none of the animals in the control group.
Under the condition of the maximization test and with respect to the evaluation criteria the test substance exhibits no skin-sensitization potential.
Reference
Appearance and behaviour of the test substance group were not different from the control groups with the following exceptions: At the end of the study, the mean body weight of the treatment group animals was slightly higher as in the control group animals. No mortalities occurred.
The animals in the test item group and in the control group showed reddening and wheals and grey wheals with red surrounding at the injection sites after 48 hours. Red wheals and encrustations at the injection sites of the first induction were recorded after 7 days in the control group and in the test item group. At day 9, directly after removal of the patch of the second induction, the treatment area of the second induction showed skin effects (grade 1) in 4 of 10 animals in the testitem group and in 1 of 5 animals in the control group as a signs of local irritation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
To determine the skin-sensitizing properties of the test substance the guinea pig maximization test was performed on female guinea pigs according to OECD guideline 406. The study was conducted with the following test substance concentrations:
intradermal induction: 5%
topical induction: 25%
challenge: 25%
The test substance was formulated in polyethylene glycol 400 to yield a suspension. The challenge using a 25% test item formulation led to no skin effects in the animals in the treatment group and to none of the animals in the control group.
Under the condition of the maximization test and with respect to the evaluation criteria the test substance exhibits no skin-sensitization potential.
Migrated from Short description of key information:
The test substance has no skin sensitizing potential.
Justification for selection of skin sensitisation endpoint:
Only one study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the study result a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not warranted.
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