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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: 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

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
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)
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:
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
Body weight:
dose 1.0 ml/kg bw, (body weight) bw start: 176 g - bw after 14 days: 235 g
dose 1.2 ml/kg bw, (body weight) bw start: 186 g - bw after 14 days: 237 g
dose 1.4 ml/kg bw, (body weight) bw start: 177 g - bw after 14 days: 228 g
dose 1.5 ml/kg bw, (body weight) bw start: 175 g - bw after 14 days: 225 g
dose 2.0 ml/kg bw, (body weight) bw start: 175 g - bw after 14 days: 237 g
dose 2.1 ml/kg bw, (body weight) bw start: 174 g - bw after 14 days: -
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).