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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 27, 1988 - September 30, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test was conducted according to OECD Test Guideline No. 405, 1987 and under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

Directive 84/449/EEC

Deviations:

not applicable

GLP compliance:

yes

Remarks:

Statement of Compliance

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
- Physical state: viscous oil
- Stability under test conditions: stable for at least 6 month

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fullinsdorf, Switzerland
- Age at study initiation:
Male: 14 weeks
Females: 15 weeks
- Weight at study initiation:
Male: 2.4 kg
Females: 2.5 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet: ad libitum pelleted standard rabbit maintenance diet
- Water: ad libitum community tap water
- Acclimation period: Four days under laboratory conditions after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10- 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted (100%)

Duration of treatment / exposure:

72 hours (not rinsed)

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

1 male, 2 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed

SCORING SYSTEM: subjective numerical according to OECD Guideline 405 (corneal, iridic and conjunctival irritation (redness/chemosis)).

TOOL USED TO ASSESS SCORE: slit-lamp 30 SL/M and Varta Cliptrix diagnostic-lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Remarks:

cumulative

Basis:

mean

Time point:

other: 24, 48 and 72 hrs

Score:

0

Remarks on result:

other: Not rinsed

Results 2

Irritation parameter:

other: Primary irritation score (100%)

Basis:

other: calculated by totaling the individual cumulative scores at 1, 24, 48 and 72 hours and then dividing by the number of figures

Time point:

other: 1, 24, 48 and 72 hrs.

Score:

0

Remarks on result:

other: Not rinsed

Irritant / corrosive response data:

Coloration: Brown staining of the eyelashes of the treated eyes by pigment or coloring of the test article was observed in all three animals at 1 hour;
from 1 to 48 hrs., and from I to 72 hrs. after the test article application.
Corrosion: no corrosion of the cornea was observed at any of the measuring intervals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Primary Irritation Score = 0 = 1.2 Criteria used for interpretation of results: not specified

Conclusions:

Under the conditions of this experiment, D,L-alpha-Tocopherol was found to cause a primary irritation score of: 0.00, when applied to the rabbit eye mucosa.
Brown staining of the eyelashes of the treated eyes by pigment or coloring of the test article was observed in all three animals at 1 hour; from 1 to 48 hrs., and from 1 to 72 hrs. after the test article application.
No corrosion was observed at any of the measuring intervals.

Executive summary:

Single application of D,L-alpha-Tocopherol was well-tolerated on the rabbit eye (primary irritation score = 0.0).

Based on this result it can be expected that occasional contamination of the human eye by D,L-alpha-Tocopherol will be harmless for human health.