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Diss Factsheets

Administrative data

Description of key information

Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating

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:
from October 3rd, 1988 to October 7th, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to the Test Guideline B.4 of the EEC Directive 84/449/EEC and OECD guideline N°404
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
test substance was applied under occlusive conditions without justification
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
test substance was applied under occlusive conditions without justification
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Healthy male, young adult, New Zealand White albino rabbits, obtained from
ENKI—Konijnenfarm, Someren, the Netherlands, were used as experimental
animals. Age at study initiation: young adult.
The body weight range was 2571—3108 g. The animals were
identified by earmarking, and subsequently housed individually in
suspended, galvanized cages, fitted with a wire—mesh floor and front.
Acclimation period : 6 days.
The cages were placed in a room, controlled for light (12 hours light/12 hours
dark cycle), temperature (18 ± 3°C), ventilation (c. 10 air changes/hour),
and relative humidity (at least 40%) throughout the test period.
A standard laboratory rabbit diet and tap water were provided ad libitum.
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
1:1 ratio of test substance and water
Controls:
other: not required, the untreated site of the same rabbit served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.0 g
- Concentration (if solution): 50%

VEHICLE
- Amount(s) applied (volume or weight with unit): 1.0 g
- Concentration (if solution): 50%
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: a shaved, 2.5 cm diameter area on the back or flank of the rabbit
- Type of wrap if used: a plastic cup with the test solution (0.5 g test substance, 0.5 g water) was placed on an area of intact skin and fixed to the application site by means of adhesive tape (Leukopor, BDF). The entire trunk of the rabbit was wrapped with self-adhesive gauze (Fixomull, art. No. 2112, BDF, Germany) to hold the cup in place.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the substance was removed from the skin area after exposure ended
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
There were no skin irritation reactions at any time point in any animal.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the resuits obtained it is conciuded that, under the
conditions of this study and according to the EEC—standards (as published
in the Official Journal of the European Coxumunities, L 257, Volume 26,
16 September 1983), “AF—366” is not irritating or corrosive to skin.
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:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to the Test Guideline B.5 of the EEC Directive 84/449/EEC and OECD guideline N°405
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Healthy male, young adult, New Zealand White albino rabbits, obtained from
ENKI—Konijnenfarm, Someren, the Netherlands, were used as the experimental
animals. The body weight range was 2670—3055 g. The animals ware
identified by earmarking, and subsequently housed individually in
suspended, galvanized cages, fitted with a wire—mesh floor and front. The
cages ware placed in a room, controlled for light (12 hours light42 hours
dark cycle), temperature (18 ± 3°C), ventilation (c. 10 air changes/hour),
and relative humidity (at least 40%) throughout the test period.
A standard laboratory rabbit diet and tap water ware provided ad libitum.
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as the control
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.1ml (0.071g)
Duration of treatment / exposure:
at least 1 second
Single application without washing
Observation period (in vivo):
72 hours
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not washed after application
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritant / corrosive response data:
Remains of the test substance were observed in the treated eye of 3/3 rabbits 1 hour after instillation, but disappeared within 24 hours. At the 1-hour reading time point, 3/3 rabbits had slight to moderate conjunctivae (redness) and slight chemosis. 24 and 48 hours after instillation, 2/3 rabbits still had slight conjunctivae and chemosis. All the eye irritation effects had cleared within 72 hours.

Table 1. Results of eye irritation study

 

Rabbit #

 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

1

 

 

 

 

1

1

1

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.0

0.0

0.0

0.0

2

 

 

 

 

1

1

1

0

0

24

1

1

0

0

48

1

1

0

0

72

0

0

0

0

average

0.67

0.67

0.0

0.0

3

 

 

 

 

1

2

1

0

0

24

1

1

0

0

48

1

1

0

0

72

0

0

0

0

average

0.67

0.67

0.0

0.0

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

average

score

1

1.33

1.00

0.00

0.00

24

0.67

0.67

0.00

0.00

48

0.67

0.67

0.00

0.00

72

0.00

0.00

0.00

0.00

24+48+72

0.45

0.45

0.00

0.00

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the resuits obtained it is concluded that, under the
conditions of this study and according to the EEC—standards (as published
in the Official Journal of the European Communities, L 257, Volume 26, 16
September 1983), the substance “AF—366” is not irritating or corrosive to
eyes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The skin irritation potential of ethyl 3,5-dichloro-4- hexadecyloxycarbonyloxybenzoate (AF-366) was assessed in a study performed according to OECD guideline 404 (Prinsen, 1988a). 0.5 g of the test substance was moistened with 0.5 g water and applied to the shaved skin of rabbits under occlusive conditions for 4 hours. No skin irritation effects (erythema and edema) were observed in any of the animals at the reference time points 1, 24, 48 and 72 h. There was no mortality and no signs of systemic toxicity were observed.

The eye irritation potential of ethyl 3,5 -dichloro-4 -hexadecyloxycarbonyloxybenzoate (AF-366) was evaluated in a study performed according to OECD guideline 405 (Prinsen, 1988b). 0.1 mL (approximately 0.071 g) of the test substance was instilled into one eye of 3 male rabbits, without washing the eye after the 24 -hour exposure period. The irritating effects were assessed 1, 24, 48 and 72 hours after the treatment ended. 3/3 animals had slight to moderate redness (conjunctivae) and slight chemosis at the 1-hour reading time point. For all the animals, the mean values of the 24, 48 and 72 -hour reading time points were 0 -0.67 for both redness and chemosis. The irritation effects were completely reversible within 72 hours.

Justification for classification or non-classification

The available data on skin irritation and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.