Registration Dossier

Administrative data

Description of key information

1 -(vinyl)octadecyl ether was tested for acute skin irritation/corrosion in rabbits in a study according to OECD Guideline 404. The substance was not found irritating/corrosive in this test.
1 -(vinyl)octadecyl ether was tested for acute eye irritation/corrosion in rabbits in a study according to OECD Guideline 405. The substance was not found irritating/corrosive in this test.

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
Study period:
1988-01-19 to 1988-03-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study. No GLP.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
May 12, 1981
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main; Germany
- Weight at study initiation: Male: 2.90 kg; Females: 3.05 kg;
- Housing: single animals in stainless steel cages with wire mesh walk floors; floor area: 40 x 51 cm
- Diet: Kliba 341, 4 mm; Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland; abt. 130 g per animal per day
- Water: abt. 250 mL tap water per animal per day
- Acclimation period: at least 8 days before beginning of the study; same housing conditions as during the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%):30 -70
- Photoperiod (hrs dark / hrs light): !2 h/12 h (6.00 - 18 .00 hours/18 .00 - 6 .00 hours)
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted;
Amount applied: 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
15 days
Number of animals:
3 (1 male, 2 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: four layers of absorbent gauze and porous bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water 1:1
- Time after start of exposure: 4 h

SCORING SYSTEM:
Calculation of the mean according to 83/467/EEC criteria of July 29th, 1983; for calculation of the means of erythema and edema only the readings of 24, 48, and 72 hours are used
EVALUATION OF ERYTHEMA (R) AND EDEMA (ED) :
0 = NONE
1 = VERY SLIGHT
2 = WELL-DEFINED
3 = MODERATE TO SEVERE
4 = SEVERE TO VERY SEVERE
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(0344)
Time point:
other: 24, 48, 72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 15 d
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(0342)
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(0306)
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.6
Max. score:
4
Reversibility:
fully reversible within: 15 d
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(0344)
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(0342)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(0306)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritant / corrosive response data:
Not irritating
Other effects:
No data
Interpretation of results:
not irritating
Remarks:
Migrated information
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:
experimental study
Adequacy of study:
key study
Study period:
1987-12-08 to 1988-03-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study. No GLP.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
May 12, 1981
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main; Germany
- Weight at study initiation: Males: 3.13 kg; Female: 2.88 kg;
- Housing: single animals in stainless steel cages with wire mesh walk floors; floor area: 40 x 51 cm
- Diet: Kliba 341, 4 mm; Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland; abt. 130 g per animal per day
- Water: abt. 250 mL tap water per animal per day
- Acclimation period: at least 8 days before beginning of the study; same housing conditions as during the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%):30 -70
- Photoperiod (hrs dark / hrs light): !2 h/12 h (6 .00 - 18 .00 hours/18 .00 - 6 .00 hours)
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye served as negative control.
Amount / concentration applied:
undiluted
Amount applied: 0.1 mL
Duration of treatment / exposure:
72 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 ( 2 males, 1 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Calculation of the mean according to 83/467/EEC criteria of July 29th, 1983;

TOOL USED TO ASSESS SCORE: no data
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(0212)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(0296)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(0194)
Time point:
other: 24,48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(0212)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(0296)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(0194)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
(0212)
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
(0296)
Time point:
other: 24,48,72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
(0194)
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.8
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(0212)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(0296)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(0194)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritant / corrosive response data:
Not irritating
Other effects:
No data
Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:

1 -(vinyloxy)octadecane was tested for acute skin irritation/corrosion in rabbits in a study according to OECD Guideline 404. The substance was administered undiluted (0.5 mL) in single dose to the shaved skin of three Vienna white rabbits for 4 hours. Before application, the substance was heated to about 30 °C. At the end of the exposure period, the test article was removed with Lutrol and Lutrol/water 1:1. The untreated skin sites of the animals were used as control. Evaluation of skin irritation/corrosion effects was performed 24, 48 and 72 hours after application of the test substance. The observation period was 15 days. Evaluation of the skin irritation/corrosion was performed according to criteria of EEC Directive 83/467/EEC of July 29th, 1983. The mean erythema score was 1.6 and the mean edema score was 0.1. All scores were fully reversible within 8 days (BASF, 1988).

Eye:

1 -(vinyloxy)octadecane was tested for acute eye irritation/corrosion in rabbits in a study according to OECD Guideline 405. The substance was administered undiluted (0.1 mL) in a single application to the conjunctival sac of the right eye of three Vienna white rabbits. The left eye served as control. No washing was done. Before application, the test item was heated to about 30 °C. Evaluation of eye irritation/corrosion effects was performed 24, 48 and 72 hours after application of the test substance. The observation period was 72 hours. Evaluation of the eye irritation/corrosion was performed according to criteria of EEC Directive 83/467/EEC of July 29th, 1983. The mean scores were 0.0 for cornea, 0.0 for iris, 0.8 for conjunctiva redness and 0.0 for conjunctiva swelling. All scores were fully reversible within the 72 hour obsevation period (BASF, 1988).


Justification for classification or non-classification

Based on the results obtained in skin and eye irritation studies with rabbits, 1 -(vinyloxy)octadecane has not to be classified according to Regulation (EC) No 1272/2008 (CLP, GHS).