2-phenoxyethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was performed

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-phenoxyethanol

EC Number:

204-589-7

EC Name:

2-phenoxyethanol

Cas Number:

122-99-6

Molecular formula:

C8H10O2

IUPAC Name:

2-phenoxyethan-1-ol

Specific details on test material used for the study:

- Name of test material (as cited in study report): 2-phenoxyethanol (technical grade)
- Physical state: colourless liquid
- Analytical purity: ca. 80% 2-phenoxyethanol
- Composition of test material, percentage of components: 2-phenoxyethanol, (ca. 80% 2-phenoxyethanol, ca. 18% monophenyldiglycol, ca. 0.5% monophenyltriglycol)
- Lot/batch No.: substance number: 82/135
- Expiration date of the lot/batch: May 1983

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Germany
- Age at study initiation: ca. 12 weeks
- Weight at study initiation (mean): 188 g (males), 180 g (females)
- Fasting period before study: 16 h, but water was available
- Diet (e.g. ad libitum): conventional laboratory
- Water (e.g. ad libitum): drinking water
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 6.81, 14.70, 31.60, 50.00 %
- Amount of vehicle (if gavage): 10 mL/kg b.w.
- Other: 0.5 % aqueous carboxymethyl cellulose solution

Doses:

681, 1470, 3160, and 5000 mg/kg b.w.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (once daily)

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

1 840 mg/kg bw

95% CL:

1 010 - 2 960

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

4 070 mg/kg bw

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 740 mg/kg bw

95% CL:

1 910 - 4 050

Mortality:

All animals dosed with 681 mg/kg b.w. survived the 14 d observation period. All males survived a treatment of 1470 mg/kg b.w., whereas 2 out of 5 female rats died. At a dose level of 3160 mg/kg b.w., 2 males and 4 females died, respectively. At the highest dose level 3 male and all female animals died. In all treatment groups, the latest time point where death occurred was observation day 1. Generally females were more susceptible to 2-phenoxyethanol compared to males.
Increasing dose resulted in increased mortality.

Clinical signs:

other: Dyspnoea; apathy; abnormal position; staggering; atony; deficiency in pain and cornea reflex; coma-like state; spastic gait; rough fur; exsiccosis; exophthalmoses; general poor condition

Gross pathology:

Animals that died during the study course revealed following signs at necropsy:
Congestion; lungs which were slightly inflated; sporadically reddened glandular stomach

Any other information on results incl. tables

Dose [mg/kg b.w.]	Number of dead/ all animals were investigated	Time of death	Observations
Males
681	0	--	dyspnoea; apathy; abnormal position; staggering; atony; paresis
1470	0	--	dyspnoea; apathy; abnormal position; staggering; atony; deficiency in pain and cornea reflex; coma-like state;
3160	2	1 d	dyspnoea; apathy; abnormal position; staggering; atony; deficiency in pain and cornea reflex; coma-like state;
5000	3	1 d	dyspnoea; apathy; abnormal position; staggering; atony; deficiency in pain and cornea reflex; coma-like state; spastic gait; rough fur; exsiccosis; exophthalmoses; general poor condition
LD50value	4070 mg/kg b.w.
Females
681	0	--	dyspnoea; apathy; abnormal position; staggering; atony; paresis
1470	2	1 d	dyspnoea; apathy; abnormal position; staggering; atony; deficiency in pain and cornea reflex; coma-like state;
3160	4	1 d	dyspnoea; apathy; abnormal position; staggering; atony; deficiency in pain and cornea reflex; coma-like state;
5000	5	1 h (3 animals); 1 d (2 animals)	dyspnoea; apathy; abnormal position; staggering; atony; deficiency in pain and cornea reflex; coma-like state; exsiccosis; exophthalmoses; general poor condition
LD50value	1840 mg/kg b.w.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

CLP: acute toxicity Cat. 4