3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol

Acute Toxicity: oral

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

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

Test material information

Constituent 1

Reference substance name:

3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol

EC Number:

233-466-0

EC Name:

3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol

Cas Number:

10191-41-0

Molecular formula:

C29H50O2

IUPAC Name:

2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-3,4-dihydro-2H-1-benzopyran-6-ol

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 or test system 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:

other: 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.