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Toxicological information

Acute Toxicity: oral

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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:
other: 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:
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- 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 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


IN-LIFE DATES: From: To:

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 levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
1 840 mg/kg bw
95% CL:
1 010 - 2 960
Sex:
male
Dose descriptor:
LD50
Effect level:
4 070 mg/kg bw
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:
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:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: acute toxicity Cat. 4