Registration Dossier
Registration Dossier
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: 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

Endpoint summary
Administrative data
Description of key information
Skin sensitisation: no skin sensitiser based on testing in OECD TG 406.
Respiratory sensitisation: the substance is not considered a respiratory sensitiser in absence of human data and in absence of skin sensitisation from animal/in vitro tests.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Key study Skin Sensitisation
The sensitising potential of Galaxolide (65% HHCB in DEP) was tested in a guinea pig maximization test (OECD TG 406, non-GLP). The used doses of Galaxolide were 0.5% in 0.01% dodecylbenzene sulphonate in 0.9% saline (DOBS/saline) for the intradermal injection, 100% for the induction patch, and 25% in 70% acetone/30% polyethylene glycol 400 (acetone/PEG400) for the challenge patch. These doses were selected based on preliminary irritation tests using 0.1, 0.25, 0.5, 1.0 and 2.0% Galaxolide concentrations for intradermal injections, however the selection criteria were not clear. The actual concentrations of HHCB are 0.325%, 65%, and 16.25%, respectively. Ten (six male, four female) Albino Dunkin/Hartley guinea pigs (weight 316-350g) were tested on a 2cm x 4cm area of skin in the dorsal shoulder area, clipped and shaved free of fur. Induction consisted of a 0.1 ml intradermal injection of 0.325% HHCB in DOBS/saline and 0.1 ml 50% Freund’s Complete Adjuvant in 0.9% saline. This was followed one week later by a 48-hr occluded patch saturated with 65% HHCB. Challenge applications were made 14 days later with a patch with 16.25% HHCB in 70% acetone/30% PEG 400. Two repeat challenges at weekly intervals were conducted. Observations were made after each challenge at 24 and 48 hours. Eight control animals were received induction and challenge treatments similar to the test pigs minus the test material. At challenge 1, in one animal very faint to faint erythema (score 0.5-1) was noted at 24 hours. In all three challenges three or less per group of ten animals showed very faint erythema (score 0.5) at 24 or 48 hours. There was no evidence of sensitisation in any of the guinea pigs at any of the three challenge treatments.
Other Supporting studies (EU-RAR, 2008)
Galaxolide (65% HHCB in DEP) was tested (OECD 406, in compliance with GLP, K2) for its allergenic and photo-allergenic potential in 12 albino Hartley strain guinea pigs (418 to 487 g) with Freund's adjuvant injection. Dermal induction (1% Galaxolide (65% HHCB in DEP)) was performed twice (second induction after 24hr), once including adjuvant injections, one excluding adjuvant injections. After 25 min, the sites were exposed to ultraviolet light. A control group was included. Ten to fourteen days after induction, a challenge with 1, 0.3 or 0.1% Galaxolide in ethanol (actual HHCB concentrations 0.65%, 0.2%, and 0.065%) was performed by dermal application. Thirty min later, the animals were irradiated as above, after which the test material was applied to fresh sites to check for contact sensitivity, and the sites scored at 24 and 48 hr. A second challenge was carried out 6 or 7 days later. In 1/12 a very faint trace of erythema was found at 1.0% and 0.3% Galaxolide with UVA at challenge 1 and 2. Under the conditions of the study, Galaxolide is not a photosensitiser in guinea pigs. (Parish, 1988)
In a skin sensitisation experiment with guinea pigs, 0,1% Galaxolide in physiological saline was injected intracutaneously (first injection 0.05 mL followed by 9 injections of 0.1 mL). Two weeks after induction, for the challenge 0.05 mL 0.1% was injected. After a 24-hour observation period, no signs of sensitisation were observed (Levenstein, 1963).
Additionally, several human studies are available, which have been summarized in the table below (source: EU-RAR, 2008).
Study Type
Number tested
Concentration of HHCB
Patch details
Result
Reference
HRIPT
40
3.75% Galaxolide in
alcohol
Semi-occlusive, 9
applications of 24-Hr each
Negative
Rubenkoenig
and Ede, 1964
HRIPT
43
100% 50% Galaxolide in
alcohol SDA 39Cl
Semi-occlusive, 8-9
applications of 24-Hr each
Negative
Guillaume et al.,
1973a
HRIPT
42
100% neat HHCB, no
vehicle
Semi-occlusive, 8-9
applications of 24-Hr each
Negative
Guillaume et al.,
1973b
Maximization
10
65% HHCB in DEP,
vehicle-petrolatum
Occlusive, 48-hr patch on
5 alternate days.
Negative
Epstein, 1974
Maximization
24
65% HHCB in DEP,
vehicle-petrolatum
Occlusive, 48-hr patch on
5 alternate days.
Negative
Epstein, 1979
The available data with guinea pigs and humans (HRIPT and maximization tests) provide no evidence of potential for induction of sensitisation for HHCB. There is no evidence from studies in experimental animals or with humans, that HHCB is a photosensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Respiratory sensitisation can be assessed using human data such as indicated in R7.3.5.2 of the ECHA guidance (2015) that indicate respiratory reactions e. g. from consumer experience or occupational exposure. In case no such data are available the respiratory sensitisation can be assessed using the integrated evaluation strategy for respiratory sensitisation data in the ECHA guidance (R7A, Fig. 7.3-4, 2017), which says that if the substance is not a skin sensitiser, it is unlikely to be a respiratory sensitiser.
Justification for classification or non-classification
Based on the available skin sensitisation studies, test item does not have to be classified for skin sensitisation in accordance with EU CLP (1272/2008 and its amendments.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.