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EC number: 700-169-7 | CAS number: 7646-67-5
- 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:
The test item HEAA does not show an allergenic potential when tested up to concentration of 10% w/v.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 April 2004 to 21 April 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- Batch number: 031128
Purity: 99% - Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Netherlands, B.V. Postbus 6174, NL-5960 AD Horst, The Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 20.2 - 20.7g
- Housing:individual in Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132, Muttenz).
- Diet: pelleted standard Kliba 3433, batch no. 78/03 mouse maintanace diet (Provimi Kliba AG, CH-4303 Kaiseraugst), avaliable ad libitum.
- Water:Community tap water from Itingen, avaliable ad libitum.
- Acclimation period: Under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light / 12 hours dark cycle with at least 8 hours music during the light period. - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 2.5, 5 and 10% w/v
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
To determine the highest non-irritant and technically applicable test item concentration, a non-GLP pretest was performed in two mice with concentrationss of 5, 10, 25 and 50% w/v. The test item in main study was assayed at three consecutive concentrations. The top dose is the highest technically applicable concentration whilst avoiding systemic toxicity and excessive local irritation.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT:
Each test group of mice was treated by topical application to dorsal surface of each ear lobe with different test item concentrations of 2.5%, 5% and 10%, once daily for three consecutive days.
Five days after the first topical application, all mice were admistered with 250 uL of 3HTdR by intravenous injection via a tail vein.
Approximately five hours after treatment with 3HTdR all mice were euthanized by inhalation of CO2. The level of 3HTdR incorporation was then measured.
Criteria used to consider a positive response:
First, the exposure to at least one concentration of test item resulted in an incorporation of 3HTdR at leasst 3-fold or greater than that recorded in control mice; Second, the data are compatible with conventional dose response, although allowance must be made for either local toxicity or immunological suppression. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured on a ß-scintillation counter.
Test item concentration % (w/v) S.I.
Group 2 5 1.5
Group 3 10* 2.3*
Group 4 25* 8.4*
EC3 = 11.7% (w/v)
A clear dose-response was observed
*This value was used in calculation of EC3
No deaths occurred during the study period.
No clnical signs were observed in any animals of the control group, Group 2 (5%) or Group 3 (10%). Approximately 90 minutes after the first topical application, a slight ear erythema was observed at both dosing sites in all mice of Group 4 (25%).
The body weight of the animals, recorded prior to the 1st application and prior to necropsy, was within the range, commonly recorded for animals of this strain and age. - Key result
- Parameter:
- SI
- Value:
- 0.5
- Test group / Remarks:
- 2.5% w/v test item
- Key result
- Parameter:
- SI
- Value:
- 0.5
- Test group / Remarks:
- 5% w/v test item
- Key result
- Parameter:
- SI
- Value:
- 0.6
- Test group / Remarks:
- 10% w/v test item
- Cellular proliferation data / Observations:
- CLINICAL OBSERVATIONS:
No deaths occurred during the study period.
No clinical signs were observed in any animals of the control group, 2.5% or 5% group. On the third application day, a slight ear erythema was observed at both dosing sites in all mice of 10% group.
BODY WEIGHTS:
The body weight of the animals, recorded prior to the 1st application and prior to necropsy, was within the range commonly recorded for animals of this strain and age. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item HEAA does not show an allergenic potential when tested up to concentration of 10% w/v.
- Executive summary:
The study was performed to assess skin sensitisation potential of HEAA to mice with LLNA assay, according to OECD Guideline 429, under GLP.
The test item HEAA does not show an allergenic potential when tested up to concentration of 10% w/v.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The study was performed to assess skin sensitisation potential of HEAA to mice with LLNA assay, according to OECD Guideline 429, under GLP.
The test item HEAA does not show an allergenic potential when tested up to concentration of 10% w/v.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation:
LLNA study give negative result with SI value of 0.6.
According to Regulation (EC) No 1272/2008, table 3.4.2, this substance should not be classified for this endpoint.
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.
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