Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
non-GLP
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Vitamin E acetate
- Lot/batch No.: batch no. 7459
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Savo Med. Versuchstierzuchten GmbH, Kisslegg (Germany)
- Age at study initiation: no data
- Weight at study initiation: 2.47 kg (male) 2.25 kg (male) and 2.40 kg (female
- Housing: individually in cages without bedding
- Diet: Kliba 341, ca. 130 g/day
- Water: tap water, ca. 250 ml/day
- Acclimation period: at least 8 days before the beginning of the study, same housing conditions as during the study
The rabbits were identified by ear tattoo.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 (6.00-18.00 h/18.00-6.00 h)
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 (2 males, 1 female)
Details on study design:
The fur of each rabbit was clipped at least 15 hours prior to the start of the study.

TEST SITE
- Area of exposure: upper third of the back or flanks
- % coverage: no data
- Type of wrap if used: Test patches (size: 2.5 cm x 2.5 cm) were secured in position with a porous dressing (4 layers of absorbent gauze and porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing: Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Draize scores: 30-60 minutes after removal of the test patches and at 24, 48, and 72 hours after beginning of application
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test substance was not irritating. Mean score was 0.0 for both erythema and edema.
Very slight (grade 1) erythema was observed in 3/3 rabbits at the 4-hour reading. The skin of all animals was normal at the 24-hour reading and later.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the test substance was not a skin irritant, mean score was 0.0 for both erythema and edema.
Executive summary:

A study was conducted to determine the skin irritation potential of the test substance according to OECD Guideline 404 study. The undiluted test substance was applied to the skin of three Vienna White rabbits for 4 hours. Under the study conditions, the test substance was not a skin irritant, mean score was 0.0 for both erythema and edema (BASF, 1989).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: RA study
Justification for type of information:
Refer to the section 13 for details on the read across justification.
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Vitamin E acetate
- Lot/batch No.: batch no. 7459
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach (Germany)
- Age at study initiation: no data
- Weight at study initiation: 3.60 kg (male), 3.55 kg (female) and 3.82 kg (female
- Housing: individually in cages without bedding
- Diet: Kliba 341, ca. 130 g/day
- Water: tap water, ca. 250 ml/day
- Acclimation period: at least 8 days before the beginning of the study, same housing conditions as during the study
The rabbits were identified by ear tattoo.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 (6.00-18.00 h/18.00-6.00 h)
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (instilled into the conjunctival sac of the right eye of each of 3 White Vienna rabbits)
- Concentration (if solution): undiluted
Duration of treatment / exposure:
Eyes were not rinsed after instillation.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 (1 male, 2 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed
- Time after start of exposure: not applicable

SCORING SYSTEM:
Draize scores. The eyes were scored at 1, 24, 48, and 72 hours after instillation.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test substance was not irritating. Mean score was 0.0 for cornea, iris, and conjunctival swelling, and 0.2 for conjunctival redness.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the read across study, a slight irritation was noted at 1-48 h, the eyes were normal at 72 h.
Executive summary:

A study was conducted to determine the eye irritation potential of the read across substance according to OECD Guideline 405. The undiluted test substance was instilled into the right eye of each of three rabbits. The left eyes remained untreated and served as control. The eyes were scored at 1, 24, 48, and 72 h after instillation. Based on the results of the read across study, a slight irritation was noted at 1 -48 h. The eyes were normal at 72 h. Under the study conditions, the substance was found to be not irritating to rabbit eyes (BASF, 1989).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

A study was conducted to determine the skin irritation potential of the read across substance according to OECD Guideline 404 study. The undiluted test substance was applied to the skin of three Vienna White rabbits for 4 h. The treated skin area was observed and lesions were scored at 24, 48 and 72 h post application. Based on the results of the read across study, the mean score was found to be 0.0 for both erythema and edema. Under the study conditions, the substance was found to be not irritating to rabbit skin (BASF, 1989).

Eye irritation:

A study was conducted to determine the eye irritation potential of the read across substance according to OECD Guideline 405. The undiluted test substance was instilled into the right eye of each of three rabbits. The left eyes remained untreated and served as control. The eyes were scored at 1, 24, 48, and 72 h after instillation. Based on the results of the read across study, a slight irritation was noted at 1 -48 h. The eyes were normal at 72 h. Under the study conditions, the substance was found to be not irritating to rabbit eyes (BASF, 1989).

Justification for classification or non-classification

The available in vivo studies on the read across substance, dl-alpha-tocopheryl acetate, indicate that the test substance is not a skin or eye irritant and does not meet the requirement for classification according to EU CLP (EC 1272/2008) criteria.