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Diss Factsheets

Administrative data

Description of key information

The primary skin irritancy of the undiluted test substance in New Zealand White rabbits was evaluated in compliance with the conditions specified in EPA OTS 798.4470 (Acute Dermal Irritation). No evidence of corrosion was found. Two (2) application sites exhibited minimal erythema at 14 days. All other sites exhibited no signs of irritation at 14 days.

The eye irritation potential of the undiluted test substance in New Zealand White rabbits was evaluated in compliance with the conditions specified in EPA OTS 798.4500 (Acute Eye Irritation). Under the conditions of this test, the test article displayed only minimal ocular irritant. All animals returned to normal before 7 days.

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:
July 19, 1995 to October 13, 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Version / remarks:
July 1, 1991
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
The test substance was received from the C.P. Hall Company on July 5, 1995. The BIN number was 024910
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Six (3M:3F) New Zealand white rabbits, weighing approximately two (2) kilograms and about three (3) months of age, were obtained from Davidson Mill Breeding Laboratories in Jamesburg, New Jersey. Animals were checked carefully upon receipt for diarrhea and dehydration, respiratory difficulties, postural deficiencies, and general condition.

Animals were acclimated for six (6) days prior to test initiation. They were individually housed in stainless steel cages, in a room with 12 hour light/dark cycle. The room temperature was controlled to comply with Animal Welfare Regulations with an approximate range of 65° to 75° F. The humidity was also monitored. Diet consisted of Lab Diet Cerified Rabbit Diet #5322, as well as water, ad libitum. Animals were identified through individual markings on the outer ear of each animal, as well ac a cage label.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
14 days maximum
Number of animals:
6
Details on study design:
Twenty-four (24) hours prior to test initiation, the animals were reexamined. Any animals in poor condition, and particularly animals with skin eruptions or dermal lesions, were not used. Animals were prepared for testing by close clipping the hair of the mid-dorsal area of the trunk, between the scapulae and the pelvis, using an Oster® small animal clipper equipped with a #40 (surgical) head. Care was taken to avoid abrasion of the skin during clipping.

Immediately prior to test initiation, the animals were placed in wooden restrainers. One (1) test site, approximately six (6) centimeters square, was chosen on each animal. Each site remained intact. A single application of one-half (0.5) of a milliliter of the test article was made to each test site. The test article was then covered with a five (5) cm2 surgical gauze pad (Johnson & Johnson gauze sponge). The latter was held in place with three (3) inch Johnson & Johnson Dermicel® hypo-allergenic cloth tape, semi-occlusively.

The wrapping and test article were removed four (4) hours following application. Remaining test article was gently washed from the skin with water and paper towels. Each test site was individually examined and scored 30 to 60 minutes after unwrapping for erythema and edema using the Draize skin scoring scale (refer to the table). The presence of effects not listed in the scoring Kai.: was also noted. Observations continued until all irritation subsides or irritation present was confirmed to be irreversible (14 days maximum).

The daily scores were averaged and evaluated in conjunction with the nature and reversibility of the response observed.
Irritation parameter:
overall irritation score
Remarks:
Average Draize scores
Basis:
mean
Time point:
14 d
Score:
2.3
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
14 d
Score:
1.15
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks:
Minimal irritation persisting to 14 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks:
Minimal irritation persisting to 14 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks:
Minimal irritation persisting to 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks:
minimal irritation persisting until 14 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks:
minimal irritation persisting until 14 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks:
minimal irritation persisting until 14 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #6
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible

Intact Skin
Rabbit No. Erythema Score Oedema Score Comments
/Observation Time
       
No. 1      
4 hour 0 0  
24 hour 1 0  
48 hour 1 0  
72 hour 2 1  
7 days 2 0  
14 days  1  0  
Mean 24,48, 72 1.33 0.33  
No. 2      
4 hour 0 0  
24 hour 1 0  
48 hour 1 0  
72 hour 1 0  
7 days 1 0  
14 days 0 0  
Mean 24,48, 72 1.00 0.00  
No. 3      
4 hour 0 0  
24 hour 0 0  
48 hour 0 0  
72 hour 2 0  
7 days 1 0  
14 days 0 0  
Mean 24,48, 72 0.67 0.00  
No. 4      
4 hour 0 0  
24 hour 0 0  
48 hour 0 0  
72 hour 2 0  
7 days 0 0  
14 days 0 0  
Mean 24,48, 72 0.67 0.00  
No. 5      
4 hour 0 0  
24 hour 1 0  
48 hour 1 0  
72 hour 1 1  
7 days 2 1  
14 days 1 0  
Mean 24,48, 72 1.00 0.33  
No. 6      
4 hour 0 0  
24 hour 0 0  
48 hour 0 0  
72 hour 1 0  
7 days 1 0  
14 days 0 0  
Mean 24,48, 72 0.33 0.00  
Interpretation of results:
GHS criteria not met
Conclusions:
According 40 CFR 798.4470 (July 1, 1991) and under the conditions of this test, this test article elicited minimal to mild irritation. Two (2) sites exhibited minimal erythema at 14 days. All other sites exhibited no signs of irritation at 14 days.
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:
July 19, 1995 to October 13, 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Version / remarks:
July 1, 1991
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
The test substance was received from the C.P. Hall Company on July 5, 1995. The BIN number was 024910
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Six (3M:3F) New Zealand white rabbits, weighing approximately 1.5 - 2.0 kilograms and about three (3) months of age, were obtained from Davidson Mill Breeding Labs, Jamesburg, NJ. The animals were checked carefully upon receipt for ocular defects, diarrhea and dehydration, respiratory difficulties, postural deficiencies, and general condition.

Animals were acclimated for five (5) days prior to test initiation. They were housed in stainless steel cages, in a room with a 12 hour light/dark cycle. The room temperature was controlled to comply with Animal Welfare regulations with an approximate range of 65° to 75° F. The humidity was also monitored. The animals were identified through individual ink markings on the outer ear of each animal, as well as a cage label. Diet consisted of Lab Diet Certified Rabbit Diet #5322, as well as water, ad libitum.
Vehicle:
unchanged (no vehicle)
Remarks:
The contralateral eye (untreated) served as control.
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
The eyes of the animals remained unwashed for the duration of the study (72 hours)
Observation period (in vivo):
Up to 21 days or until all signs of reversible irritation subsided.
Number of animals or in vitro replicates:
6
Details on study design:
In the technique of determining toxicity of substances to ocular mucosa, observation of injuries was made on the cornea, iris, and the bulbar and palpebral conjunctivae. Numerical scores were assigned to lesions observed according to the Draize scale. (Refer to appended table). In this
system of scoring, the injuries to the cornea and iris account for approximately 80% of the score; these structures are purposely weighted because of their vital role in vision. The presence of lesions not described in the Draize scale was also noted.

All eyes were examined with fluorescein sodium within 24 hours prior to initiation for ocular defects not visible to the naked eye. Immediately prior to test initiation, the animals were momentarily restrained. A dose of one-tenth (0.1) of a milliliter of the test article was placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test article was dropped. The eyelids were gently held together for one (1) second. The contralateral eye, remaining untreated, served as a control. The eyes of the animals remained unwashed.

Observations of ocular irritation were recorded 1, 24, 48 and 72 hours following instillation of the test article. Additional readings were made at 4, 7, 10, 14, 18 and 21 days or until all signs of reversible irritation subsided. Readings were made utilizing a hand held ophthalmoscope. All eyes were examined with fluorescein sodium after dosing, until no retention was observed. Bodyweights were recorded prior to initiation and at termination of the study.

Daily scores were determined for each animal using the weighting system described in the Draize scale. Mean daily scores were determined.
Irritation parameter:
other: Average Draize score
Basis:
mean
Time point:
other: 1 hour
Score:
3
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
other: Average Draize score
Basis:
mean
Time point:
24 h
Score:
2.3
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
other: Average Draize score
Basis:
mean
Time point:
48 h
Score:
1.3
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
other: Average Draize score
Basis:
mean
Time point:
72 h
Score:
1.7
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
other: Average Draize score
Basis:
mean
Time point:
other: 4 days
Score:
0.3
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
other: Average Draize score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Other effects:
No anaimals showed fluorescein retention at either 24 or 48 hours

Primary Ocular Irritation Results

Rabbit Cornea Iris Conjunctivae Total
Number Hr/Day (Opacity) (Area) Erythema Swelling Discharge Score
1 1 hours 0 0 0 2 0 0 4
(male) 24 hours 0 0 0 2 0 0 4
48 hours 0 0 0 2 0 0 4
72 hours 0 0 0 2 0 0 4
96 hours 0 0 0 2 0 0 4
7 days - - - - - - -
Mean/An 1 (24,48 and 72 hr) 0.00 0.00 2.00 0.00
2 1 hours 0 0 0 1 0 0 2
(male) 24 hours 0 0 0 2 0 0 4
48 hours 0 0 0 1 0 0 2
72 hours 0 0 0 1 0 0 2
96 hours 0 0 0 1 0 0 2
7 days 0 0 0 0 0 0 0
Mean/An 2 (24,48 and 72 hr) 0.00 0.00 1.33 0.00
3 1 hours 0 0 0 1 0 0 2
(male) 24 hours 0 0 0 1 0 0 2
48 hours 0 0 0 0 0 0 0
72 hours 0 0 0 1 0 0 2
96 hours 0 0 0 0 0 0 0
7 days 0 - - - - - -
Mean/An 3 (24,48 and 72 hr) 0.00 0.00 0.67 0.00
4 1 hours 0 0 0 2 0 0 4
(female) 24 hours 0 0 0 1 0 0 2
48 hours 0 0 0 0 0 0 0
72 hours 0 0 0 0 0 0 0
96 hours - - - - - - -
7 days - - - - - - -
Mean/An 4 (24,48 and 72 hr) 0.00 0.00 0.33 0.00
5 1 hours 0 0 0 1 0 0 2
(female) 24 hours 0 0 0 0 0 0 0
48 hours 0 0 0 0 0 0 0
72 hours 0 0 0 0 0 0 0
96 hours - - - - - - -
7 days - - - - - - -
Mean/An 5 (24,48 and 72 hr) 0.00 0.00 0.00 0.00
6 1 hours 0 0 0 2 0 0 4
(female) 24 hours 0 0 0 1 0 0 2
48 hours 0 0 0 1 0 0 2
72 hours 0 0 0 1 0 0 2
96 hours 0 0 0 0 0 0 0
7 days - - - - - - -
Mean/An 6 (24,48 and 72 hr) 0.00 0.00 1.00 0.00
Interpretation of results:
GHS criteria not met
Conclusions:
According to 40 CFR 798.4500 (July 1, 1991) and under the conditions of this test, this test article is minimal ocular irritant. All animals returned to normal before seven (7) days.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The test substance is a member of a category of aliphatic esters submitted by The American Chemistry Council's (ACC) Aliphatic Esters Panel (Panel) under the High Production Volume (HPV) Chemical Challenge Program (ACC, 2003). The structurally similar material 2 -Ethylhexanoic acid, diester with tetraethyleneglycol (CAS 18268 -70 -7) was tested for primary skin irritancy of the undiluted test substance in New Zealand White rabbits was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide, and Rodent icide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines. Moderate irritation persisted 72 hours following applications. All animals were held for 7 days at which time all irriatation had cleared. The Primary Irritation Index (PII) was found to be 2.8 based on erythema and edema. The only change noted in the coloration and/or texture of the skin was desquamation that persisted in 2 of the 6 test animals. No evidence of corrosion was found.

The primary eye irritancy of the structurally similar material 2 -Ethylhexanoic acid, diester with tetraethyleneglycol (CAS 18268 -70 -7), was tested undiluted in New Zealand White rabbits in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines. The test material produced conjunctival irritation, which had cleared by the 72 hour reading. Maximum total irritation scores for individual animals ranged from 4 to 8. There was no evidence of corrosion noted.

Justification for classification or non-classification

Based on mean 24, 48 and 72 hour scores for erythema/eschar or for oedema, the test substance would not be classified as a skin irritant according to the European Regulation (EC) No. 1272/2008 on classification and labelling of chemicals.

Based on the results of testing in rabbits, the test substance would not be classified as an eye irritant according to the European Regulation (EC) No. 1272/2008 on classification and labelling of chemicals.