Registration Dossier
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EC number: 214-946-9 | CAS number: 1222-05-5
- 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

Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- From 7 JUNE 1977 to 12 AUG 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study was carried out prior to GLP and OECD guidelines but was conducted according to acceptable procedures at the time.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Guideline:
- other: The followed procedure is similar to OECD 401/402, however the application is done by intraperitoneal injection
- Deviations:
- not specified
- Principles of method if other than guideline:
- Groups of five female rats (Charles River Sprague Dawley - weighing 106-155 g) were dosed with Galaxolide 50 (65% HHCB in DEP) by intraperitoneal injection at different doses and observed for 7 days. This study was conducted prior to GLP and OECD guidelines but was conducted according to acceptable procedure at the time.
- GLP compliance:
- not specified
- Remarks:
- This study was prior to GLP and OECD guidelines but was conducted according to acceptable procedures at the time.
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited int he study report): Galaxolide 50
- Date received: 7/15/77
- Physical state: A clear liquid
- Lot/Batch No.: SG-087-2030
- Purity: Assumed 50% active
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals and environmental conditions:
- Initial bodyweight 106-155 g
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 0.1, 0.215, 1.0 and 4.64 g/kg bw Galaxolide 50, equivalent to 0.065, 0.14, 0.65 and 3.0 g/kg bw HHCB.
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Immediately after dosing at one, four and 24 hrs and once daily thereafter for at total 7 days.
- Necropsy of survivors performed: yes - Statistics:
- Mortality data was analyzed statistically, utilizing the tables of Horn, HJ. Biometrics 12, 311, 1956.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 160 mg/kg bw
- Remarks on result:
- other: The LD50 was 1.58 g/kg BW expressed as HHCB equivalents
- Mortality:
- 4/5 animals treated at the high dose (4.64 g/kg bw Galaxolide 50) were found dead at 24h. The remaining animal treated with this dose was found dead the next day. There were no deaths at the dose of 1.0 g/kg bw.
- Clinical signs:
- At 1.0 g/kg bw Galaxolide 50, 3 animals were observed to be in a depressed condition within two hours of dosing but returned to normal at 24h. Lethargy and depression were observed in 4/5 animals at 4.64 g/kg bw Galaxolide within 2 hrs. The remaining animal was prostate at 24 hr.
- Gross pathology:
- Animals found dead exhibited the effects expected at their respective stages of autolysis; all other animals exhibited no remarkable necropsy findings.
Any other information on results incl. tables
Table 1: mortality data
Time of death | Time of death | Time of death | ||
Dose (g/kg) | Concentration (%) | Immediate | 1 -24 hrs | 2 -7 days |
0.1 | 100 | 0/5 | 0/5 | 0/5 |
0.215 | 100 | 0/5 | 0/5 | 0/5 |
1 | 100 | 0/5 | 0/5 | 0/5 |
4.64 | 100 | 0/5 | 4/5 | 4/5 |
Applicant's summary and conclusion
- Conclusions:
- The acute intraperitioneal toxicity of HHCB is low. There is no need to classify HHCB for acute toxicity.
- Executive summary:
Groups of five female rats (Charles River Sprague Dawley – weighing 106-155 g) were dosed with Galaxolide 50 (65% HHCB in DEP) by intraperitoneal injection at doses of 0.1, 0.215, 1.0 or 4.64 g/kg bw, (equivalent to 0.065, 0.14, 0.65 or 3.0 g/kg bw HHCB) and observed for 7 days. At 1.0 g/kg, 3 animals were observed to be in a depressed condition within two hr of dosing but returned to normal at 24 hr. There were no deaths at this dose. Lethargy and depression were observed in 4/5 animals at the high dose within 2 hr and all were found dead at 24 hr. The remaining animal was prostate at 24 hr and found dead the next day. Based on these observations an IP LD50of 3.16 g/kg bw (equivalent to 2.1 g/kg bw HHCB) was calculated. This study was conducted prior to GLP and OECD guidelines but was conducted according to acceptable procedure at the time.
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