Benzyl alcohol

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:

other: scientifically acceptable and sufficiently documented

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Principles of method if other than guideline:

10 male rats received a single oral application per gavage of 1.0, 1.2, 1.4, 1.5, 2.0 and 2.1 ml/kg bw (= ca. 1045, 1254, 1463, 1467, 2090 and 2195 mg/kg bw) of the test substance. Post-exposure period was 14 days.

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Benzyl alcohol

EC Number:

202-859-9

EC Name:

Benzyl alcohol

Cas Number:

100-51-6

Molecular formula:

C7H8O

IUPAC Name:

phenylmethanol

Details on test material:

- Name of test material (as cited in study report): Benzylalkohol
no further data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

male Wistar rats, SPF, weight 160 - 180 g; husbandry: 5 animals per cage; breeder: Winkelmann

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

single oral application per gavage (no further data)

Doses:

1.0, 1.2, 1.4, 1.5, 2.0 and 2.1 ml/kg bw (= ca. 1045, 1254, 1463, 1467, 2090 and 2195 mg/kg bw)

No. of animals per sex per dose:

10 male rats per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: start and end of study
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

Statistics:

LD50 according Fink and Hund, Arzneimittelforschung (1965), 15, 624

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1.55 mL/kg bw

95% CL:

1.42 - 1.7

Remarks on result:

other: corresponding to 1620 mg/kg bw (density: 1.045 g/mL)

Effect levels 2

Sex:

male

Dose descriptor:

other: NOAEL

Effect level:

1 mL/kg bw

Remarks on result:

other: corresponding to 1045 mg/kg bw

Mortality:

dose 1.0 ml/kg bw, mortality 0/10; dose 1.2 ml/kg bw, mortality 1/10; dose 1.4 ml/kg bw, mortality 2/10; dose 1.5 ml/kg bw, mortality 6/10; dose 2.0 ml/kg bw, mortality 8/10; dose 2.1 ml/kg bw, mortality 10/10;

Clinical signs:

other: 1.0 ml/kg bw: no clinical findings from 1.2 ml/kg bw onwards: sedation, side and prone-position, bloody eyes and reduction of general condition

Gross pathology:

no data

Other findings:

no data

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Executive summary:

10 male rats received a single oral application per gavage of 1.0, 1.2, 1.4, 1.5, 2.0 and 2.1 ml benzyl alcohol/kg bw (= 1045, 1254, 1463, 1467, 2090 and 2195 mg/kg bw; density: 1.045 g/ml) and were observed for 14 days. Clinical signs were observed from 1.2 ml/kg bw onwards and included sedation, side and prone position, bloody eyes and reduction of general condition. The resulting LD50 was 1.55 ml/kg bw (= 1620 mg/kg bw) (Bayer AG 1978).