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Administrative data

Description of key information

2-Phenoxyethanol displayed low acute oral toxicity in rats.
2-Phenoxyethanol displayed very low acute dermal toxicity tested in rats and rabbits.
2-Phenoxyethanol displayed no effects following inhalation exposure in rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
1 840 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
1 000 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50

Additional information

Oral:

In an oral toxicity study according to OECD 401 (BASF AG, 1982), 2 -phenoxyethanol has a low acute oral toxicity in the rodent species rat (LD50 female approximately 1840 mg/kg bw). Generally males were less susceptible to 2-phenoxyethanol than females (LD50 male 4070 mg/kg). However the purity of the test substance was only 80%. In another oral toxicity study conducted according to OECD 401 (Sasol, 1983), the LD50 value for male and female rats was determined to be 1850 mg/kg bw. The purity of the test substance was > 99%.

However, these observations were contradictory to the observations made in less reliable studies. Administration of high oral doses to rats induced dyspnoea, apathy, abnormal position, staggering, atony, deficiency in pain and cornea reflex, coma like state, spastic gait, rough fur, exsiccosis, exophthalmoses and general poor condition.

Dermal:

There are two dermal acute toxicity studies with only basic data given. Based on these studies

2-phenoxyethanol has a low dermal toxicity: In rats, acute dermal toxicity was tested up to a concentration of 24575 mg/kg bw. In this test, mortalities occurred 21 to 48 h post-dosing (no further details given) (Davies 1970). The LD50 in rat was calculated to be 14391 mg/kg bw.

In rabbits, no mortality was noted at the limit dose of 2.0 mL/kg bw (corresponding to 2214 mg/kg bw) tested on abraded skin only (Doyle 1980). The only effect observed in two rabbits was a local erythema and desquamation at the dosing site, which was reversible within 3 days after dosing. Desquamation was observed in one rabbit from observation days 3-14. Thus, the LD50 was > 2214 mg/kg bw.

Inhalation: Several acute Inhalation Risk Tests (IRT) of minor relevance were available. Rats were exposed to saturated vapour for 7 or 8 hours, respectively (BASF AG 1963, Union Carbide Corp., 1982). If the vapour pressure of 0.014 hPa, respectively 0.01 hPa both at 20°Care taken into account, this corresponds to an atmospheric concentration of 80 resp. 57 mg/m3by calculation. No deaths or clinical signs were observed. The low inhalation toxicity of 2-phenoxyethanol in rat was confirmed by a Guideline subacute aerosol inhalation study performed according to GLP (BASF AG, 2007). No mortalities were seen in rats head/nose only exposed up to 1000 mg/m³ for 14 days (6 hours per day, 5 days per week). No deaths were recorded and in none of the test groups were clinical signs of toxicity observed throughout the study up to and including the maximal dose (LC50 1000 mg/m³).

If one looks at analytically measured concentrations in the 14 day inhalation study in rats, the calculated values are in line with the 14 day NOAEC of 40 mg/m3(nominal) respectively 48 mg/m3analytically determined. At this concentration the vapour fraction was about 80% and the rest was aerosol.This allows the conclusion that the LC50 of phenoxyethanol vapour is clearly above the saturated vapour concentration at room temperature after a single 8 hour exposure and even if exposure is prolonged to 14 days.

Justification for classification or non-classification

Acute oral toxicity:

CLP: Cat. 4 / EU: Xn R22

Acute dermal toxicity:

CLP: not classified / EU: not classified

Acute inhalation toxicity: (testing up to 1000 mg/m3 displayed no effects)

CLP: not classified / EU: not classified