Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: similar OECD 401: scientifically acceptable

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Observational period 5 days instead of 14 days; both sexes were used, but no information on ratio male/female;
GLP compliance:
no
Remarks:
Prior to GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): d,l-alpha Tocopherol

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 130 - 175 grams.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 5% gum acacia solution
Details on oral exposure:
VEHICLE
5% gum acacia solution.

Doses:
4000 mg/kg.
No. of animals per sex per dose:
10 animals per dose; no data on ratio male/female.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 5 days
- Other examinations performed: total mortality reported; no other examinations/observations reported
Statistics:
LD50 calculated by method of Miller and Tainter (Proc. Soc. Exptl. Biol. Med. 57:261, 1944).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Remarks on result:
other: 4 out of 10 animals died
Mortality:
4 animals died during the course of the study
Clinical signs:
Reported symptoms are Cyanosis and respiratory depression.

Any other information on results incl. tables

Species

Route

Dose mg/kg

# Dead/# Dosed

LD50 + S.E. mg/kg

Symptoms

 

 

 

 

 

 

Rats

P.O.

4000

4/10

>4000

Cyanosis, respiratory depression

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the current study an LD50 of >4000 mg/kg bw has been established for Wistar rats that received a single oral doses of D,L-Alpha Tocopherol. Based on the EU Criteria for classification the substance does not have to be classified (2000 - 5000 mg/kg)
Executive summary:

10 Wistar rats of both sexes, weighing 130 - 175 grams, received a single oral dose of 4000 mg/kg D,L-Alpha Tocopherol, suspended in 5% gum acacia solution. The animals were observed for five days after exposure and total mortality was reported. The LD50 was calculated by using the method of Miller and Tainter (1944). 4 out of 10 animals died. the LD50 was calculated to be >4000 mg/kg. Based on EU Criteria the substance does not have to be classified.