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Toxicological information

Eye irritation

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
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
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.