Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
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)

Test material

Constituent 1
Chemical structure
Reference substance name:
Decanoic acid, mixed diesters with octanoic acid and triethylene glycol
EC Number:
271-517-9
EC Name:
Decanoic acid, mixed diesters with octanoic acid and triethylene glycol
Cas Number:
68583-52-8
Molecular formula:
C10-H20-O2.C8-H16-O2.C6-H14-O4
IUPAC Name:
Decanoic acid, mixed diesters with octanoic acid and triethylene glycol
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

Test animals / tissue source

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.

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.