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Description of key information

Acute oral toxicity: LD50 is >3000 mg/kg bw in an OECD TG 423


Acute dermal toxicity: LD50 is >3250 mg/kg bw in an OECD TG 402


Acute inhalation toxicity 4hour LC50 is >5.04 mg/L in an OECD TG 403

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 3 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
> 5 040 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 3 250 mg/kg bw

Additional information

Key study: Acute toxicity oral


The substance is tested in an acute toxic class method test (OECD TG 423, GLP) on a group of six female rats at a dose of 2000 mg/kg bw. No mortality occurred during the study, and no clinical signs related to the test item were observed during the 14 -day observation period. Bodyweights were observed and remained normal, except for one animal. Macroscopy did not reveal any treatment related changes. The LD50 result in >2000 mg/kg bw.


Supporting study: In an Acute oral toxicity study (OECD TG 401, 1977, Minner & Foster) Galaxolide 50 (65% HHCB in DEP) was tested and administered undiluted by gavage at doses of equivalent HHCB of 0.14, 0.30, 0.65, 1.4, 3.0 g/kg to groups of 5 female Charles River Sprague Dawley rats that were then observed for mortality and signs of effects for 7 days (shorter observation time then recommended in guideline, 7 days vs 14 days). There was one death as a result of gavage error at 1.0 g/kg but no deaths at any other dose. One animal at 2.15 g/kg appeared distressed shortly after dosing but appeared normal after 2 hr. There were no effects at the high dose. An LD50 of > 4.64 g/kg bw, equivalent to >3 g/kg bw HHCB was calculated. This study was conducted prior to GLP and OECD guidelines.


Supporting study: In a limitedly reported oral gavage non-GLP study (OECD TG 401, 1975, Moreno), Galaxolide 50 (65% HHCB in DEP) was administered to 10 Wistar rats at a dose of 5000 mg/kg bw (actual dose of HHCB – 3250 mg/kg bw) followed by a 14-day observation. One rat died on day 2. The oral LD50 is determined as >3250 mg/kg bw in this study. This study was conducted prior to GLP and OECD guidelines and specific details regarding the study are not available.


Key study: Acute toxicity dermal


The substance is tested in a dermal toxicity test (OECD TG 402, GLP, IFF, 2016) on a group of five male and five female rats at a dose of 2000 mg/kg bw. No mortality occurred during the study, and no clinical signs related to the test item were observed during the 14 -day observation period. Bodyweights were observed and remained normal. Macroscopy did not reveal any treatment related changes. The LD50 result in >2000 mg/kg bw.


Supporting study: In an Acute dermal toxicity test (OECD TG 402, 1977, Minner & Foster) (Galaxolide 50 (65% HHCB in DEP) was administered undiluted by inunction to the shaved skin (area not reported) of groups of five female Charles River Sprague Dawley rats (initial bodyweight 108–187 g) in doses of 0.464, 1.0, 2.15, 4.64 or 10.0 g/kg bw (equivalent to 0.30, 0.65, 1.4, 3.0, 6.5 g/kg HHCB) that were then observed for 7 days. There were no deaths at any dose but all animals in the high dose group exhibited urine staining on their fur. A dermal LD50 of >10.0 g/kg bw (equivalent to >6.5 g/kg bw HHCB) was reported. This study was conducted prior to GLP and OECD guidelines.


Supporting study: In a limitedly reported acute dermal toxicity study (OECD TG 402, 1975, Moreno), Galaxolide 50 (65% HHCB in DEP) was applied to the skin of groups of 7 albino rabbits at a dose of 5000 mg/kg bw (equivalent to 3250 mg/kg bw HHCB). No mortallity occurred. In all animals, moderate redness of the skin was seen, in 6/7 animals moderate oedema of the skin and in 1/7 animals slight oedema of the skin was seen. The dermal LD50 is determined to de >3250 mg/kg bw in this study. This study was conducted prior to GLP and OECD guidelines.


Key study: Acute toxicity inhalation


The substance is tested in an acute toxicity inhalation test (OECD TG 403, GLP, IFF, 2016) on a group of five male and five female rats (nose only) exposed to an achieved aerosol atmosphere of a formulation of the test item with ethanol 50:50 w/w% for four hours at a dose of 5.04 mg/L (nominal 12.07 mg/L). The exposure was followed by a 14 -day observation period. No mortality occurred during the study, and no adverse clinical signs related to the test item were observed. Bodyweights were observed and remained normal. Macroscopy did not reveal any treatment related changes. The LC50 (4h) result in >5.04 mg/L.


Acute toxicity other routes


In an study from 1977 by Minner & Foster, groups of five female rats 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. Clinical signs were noted at the highest two doses, and all animals died at the highest dose. 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.

Justification for classification or non-classification

The substance does not have to be classified for acute toxicity by the oral, dermal and inhalation route according to EU CLP (EC No. 1272/2008 and its amendments).