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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 278-636-5 | CAS number: 77182-82-2
- 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
The test substance was not sensitizing in a Buehler test and a Guinea pig maximization Test (GPMT).
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:
- weight of evidence
- Study period:
- 14 Nov. - 22 Nov. 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- GLP compliant study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Deviations:
- yes
- Remarks:
- no positive control, epicutaneous induction with a non-irritatnt concentration
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Humans and domestic animals § 81-6 "Dermal sensitization study"
- Version / remarks:
- November 1992
- GLP compliance:
- yes
- Remarks:
- Quality Assurance statement available, 30 Jan. 1984
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- LLNA method was not available yet by the time the study was conducted
- Species:
- guinea pig
- Strain:
- other: Pirbright-White guinea pigs
- Remarks:
- Hoe: DHPK (SPFLac)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Females (if applicable) nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: SPF breeding colony
- Age at study initiation: not specified
- Weight at study initiation: average weight 263.2 g
- Housing: group housing
- Diet (e.g. ad libitum): ERKA 9300 complete guinea pig diet, ad libitum
- Water (e.g. ad libitum): tap water in platic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Remarks:
- 0.9%
- Concentration / amount:
- 50% / 0.5 ml
- Day(s)/duration:
- Days 1, 3, 5, 8, 10, 12, 15, 17, 19 / 6h each
- Adequacy of induction:
- other: highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Remarks:
- 0.9%
- Concentration / amount:
- 50% / 0.5 ml
- Day(s)/duration:
- Day 37 / 6h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals in treatment group
10 animals in control group - Details on study design:
- RANGE FINDING TESTS: Dermal-occlusive application of 3 concentrations (0.5%, 5%, 50% in 0.9% physiological saline) to the flank of 2 animals; treatment for 24h
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 6h
- Control group: 0.5 ml of physiological saline alone
- Site: Left flank
- Frequency of applications: 2d interval between treatment
- Duration: until day 35
- Concentrations: 50%
B. CHALLENGE EXPOSURE
- No. of exposures: single treatment
- Day(s) of challenge: Day 37
- Exposure period: 6h
- Test groups: 0.5 ml of a 50% solution
- Control group: 0.5 ml of 0.9 ml physiological saline
- Site: Right flank
- Evaluation (hr after challenge): 24h, 48h
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no erythema or oedema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no erythema or oedema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no erythema or oedema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no erythema or oedema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Group:
- positive control
- Remarks on result:
- other: no positive control
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 23 Oct. - 14 Nov. 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Deviations:
- yes
- Remarks:
- epicutaneous induction performed with a non-irritant concentration
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Humans and domestic animals § 81-6 "Dermal sensitization study"
- Version / remarks:
- November 1982
- Qualifier:
- according to guideline
- Guideline:
- other: Agricultural chemicals, Laws and Regulations Japan, MAFF
- Version / remarks:
- 1985
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 31 July 1992
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Quality Assurance Statement available, 15 Jan. 1996
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA method was not available yet by the time the study was conducted
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Remarks:
- Hoe, DHPK (SPFLac)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding colony
- Females (if applicable) nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: SPF
- Weight at study initiation: average weight 358 g
- Housing: in groups of 5
- Diet (e.g. ad libitum): ssniff Ms-H (V2233), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 hours - Route:
- intradermal
- Vehicle:
- other: isotonic saline or 50% Freund´s adjuvant
- Remarks:
- in addition the adjuvant was tested solely
- Concentration / amount:
- 1% / 0.1 ml
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: isotonic saline or 50% Freund´s adjuvant
- Remarks:
- in addition the adjuvant was tested solely
- Concentration / amount:
- 50% / 0.5 ml
- Day(s)/duration:
- Day 8 / 48 h
- Adequacy of induction:
- other: highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 50% / 0.5 ml
- Day(s)/duration:
- Day 22 / 24h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
1. Determination of primary non-irritant concentration with two animals: left flank treated with 1%, 5%, 25%, 50% in isotonic saline, 0.5 ml of test substance preparation was applied to a cellulose patch (2 * 2 cm);
24h treatment; Erythema and oedema scoring 4h after patch removal.
2. Determination of the tolerance of intradermal injections with 3 animals : Preparations (0.2%, 1%, 5%) injected twice (0.1 ml) within a dorsal area measuring 2*4 cm in the vicinity of the shoulder at three injection sites. Examination for local tolerance at 24, 48, 72, 96 h.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two intradermal injections, one dermal induction treatment
- Test groups:
- Control group: intradermal induction with Freunds´s complete adjuvant and isotonic saline; dermal induction with isotonic saline alone
- Site: intradermal injection within a dorsal area in the viscinity of the shoulder, dermal patch applied at the injection site
- Duration: intradermal induction treatment from day 1-7; dermal induction on day 8
- Concentrations: intradermal 1%, dermal 50% in vehicle
B. CHALLENGE EXPOSURE
- No. of exposures: single exposure
- Day(s) of challenge: day 22
- Exposure period: 24 h
- Test groups: 50% of test material preparation in isotonic saline
- Control group: same treatment as test animals
- Site: left flank
- Concentrations: 50% preparation in vehicle
- Evaluation (hr after challenge): 24, 48 h (days 24, 25) - Positive control substance(s):
- yes
- Remarks:
- benzocain (1% in semi-liquid paraffin for intradermal induction and 25% concentration in petrolatum for dermal induction and challenge treatment), Report no. 95.0578
- Positive control results:
- positive indication of sensitization for the positive control substance
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no erythema or oedema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no erythema or oedema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no erythema or oedema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no erythema or oedema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25% benzocain
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- instances of moderate to severe erythema, slight oedema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25% benzocain
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- instances of moderate to severe erythema, very slight oedema
- Remarks on result:
- positive indication of skin sensitisation
Referenceopen allclose all
Induction treatment
The intradermal injections with Freund's Adjuvant (with and without test substance) caused severe erythema and oedema as well as indurations and encrustations. The application sites treated with the test substance showed slight erythema. Intradermal injections of the vehicle alone caused no signs of irritation.
After the removal of the patches at day 10, severe erythema and oedema, indurated and encrusted skin were observed at the sites previously treated with Freund's Adjuvant. The application sites treated with the test substance showed slight erythema and oedema. The vehicle alone showed no signs of irritation.
Challenge treatment
The body weight gain of the animals was not impaired throughout the study. There were no clinical signs of intoxication. After challenge treatment no signs of irritation occured.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The sensitizing potential of the test substance has been evaluated in a Buehler test and a GPMT.
In the Buehler test 20 female Pirbright White guinea pigs were treated with the test substance. Additional animals were used as negative controls (10 females). The induction of sensitisation was conducted by close-patch topical applications of test substance. (0.5 ml of a 50% dilution in 0.9% physiological saline, placed under occlusive patches for 6 hrs). The test article was applied 3 times per week with a 2-d interval, for 3 weeks. The animals were challenged with the test article (0.5 ml of a 50% dilution in 0.9% physiological saline, placed under occlusive patches for 6 hrs) 2 weeks after the induction phase by close-patch topical application. The resulting reactions were evaluated at 24 and 48 hrs after the challenge treatment.
No clinical signs of intoxication were observed at any time during the study. Body weight gains showed no discernible differences between control and treatment animals. After challenge treatment no signs of irritation occurred in the treatment and control group.
In the GPMT, 20 female Pirbright-White guinea pigs were treated with test substance. 10 females were used as negative controls and 5 females for determination of the tolerance of intradermal injections. The induction of sensitisation was carried out by two intradermal injections followed by a dermal application one week later. Intradermal injections of the treatment group was performed with the following preparations: 0.1 ml 1% test substance in isotonic saline, 0.1 ml 50% Freund´s Complete Adjuvant in physiological saline, and 0.1 ml 1% test substance in 50% Freund´s Original Adjuvant. Dermal application of the treatment group was performed with 0.5 ml of 50% test substance in isotonic saline, placed under occlusive patches for 48 hrs. The animals were challenged with 0.5 ml of a 50% dilution of test substance in isotonic saline 2 weeks after the induction phase by close-patch topical application (placed under occlusive patches for 24 hrs). The resulting reactions were evaluated at 24 and 48 hrs after the challenge treatment. A positive test substance, benzocain (1% concentration in semi-liquid paraffin for intradermal induction and 25% concentration in petrolatum for dermal induction and challenge treatment) was tested according to the same procedure in a preliminary experiment.
There were no clinical signs of intoxication in the main study. Body weight gains showed no discernible differences between control and treatment animals. Intradermal injections with Freund´s Adjuvant (with and without test substance) caused severe erythema and oedema as well as indurations and encrustations. The application sites treated (intradermal injections) with the test substance showed slight erythema. Intradermal injections of the vehicle alone caused no signs of irritation in control animals. After challenge treatment, no signs of irritation occurred in the treatment and control group. The positive control substance gave the expected positive response.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the data available and in accordance with Regulation (EC) 1272/2008 (CLP), non-classification for skin sensitization is warranted.
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.