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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other: read across from analogue substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Analogue Substance #2
IUPAC Name:
Analogue Substance #2
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The test was performed on 3 male and 3 female adult New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. The animals were housed individually in metal cages, numbered by ear tags, were kept at a constant room temperature of 22 + 2° C, at a relative humidity of 55+10 % and on a 10 hour light cycle day.The animals had ad libitum access to standard rabbit food - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days. Only rabbits with normal ophthalmic findings were used for these tests

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
0.1g
Duration of treatment / exposure:
few seconds
Observation period (in vivo):
24h, 48h, 72h, 4 and 7 days
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
chemosis, redness and discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
chemosis, redness and discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
chemosis, redness and discharge
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
chemosis, redness and discharge
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
chemosis, redness and discharge
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
chemosis, redness and discharge
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
other: not classified under Regulation 1272/2008
Conclusions:
The test item was teted for eye irritation potential. Under the experimental conditions the item did not show any eye irritative properties.
Executive summary:

The test item was teted for eye irritation potential. The left eye of three males and three females of NZW rabbits were exposed for a few seconds to the test item, and three of them were rinsed with physiological saline solution. The right eye was left untreated and served as control. The cornea, iris and conjuncitvae scores were determined at 24, 48, 72h, 4 and 7 days and resulted equal to zero. Under the experimental conditions the tested item is not considered as irritant to the eye.