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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
19 February - 06 March, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized

Data source

Reference
Reference Type:
other: Unnamed report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks:
OECD ENV/MC/CHEM(98)17, 2004/9/EC AND 2004/10/EC

Test material

Constituent 1
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
At the start of the study the rabbits were in the weight range 2.0 - 3.5 kg. and were twelve to twenty weeks old.
Acclimatization period: at least five days.
The animals were housed in individual suspended cages.
Free access to mains drinking water and food (Certified Rabbit) was allowed throughout the study.
The temperature and relative humidity were set to achieve limits of 17°C to 23°C and 30 % to 70% respectively.
The rate of air exchange was 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light (06:00 to 18:00) and 12 hours of darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other: left eye of each animal was untreated
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
0.1ml of test material to the non-irrigated eye of three rabbits was performed by placing test material in the conjunctival sac of the right eye and gently pulling the lower eye lid away from the eyeball. The upper and lower eyelid were held closed for about one second after treatment to prevent loss of material and then released. The left eye was left untreated to serve as the control.
After the first animal the second and third animal was treated. in order to minimize pain, each eye was treated with anaesthetic 1 to 2 mins before treatment.
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. Additional observations were performed on day 7 to assess the reversibility of the ocular effects.
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
Before treatment both eyes were checked for sign of ocular irritation or defect with the aid of a direct light source. Only animals free of ocular damage were used in the study.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
12
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
12
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
12
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
5
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
5
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
5
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal #1
Time point:
72 h
Score:
17
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal #2
Time point:
72 h
Score:
17
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal #3
Time point:
72 h
Score:
17
Reversibility:
fully reversible
Irritant / corrosive response data:
group mean score: 17.0
Other effects:
none noted

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: modified Kay and Calandra classification system
Conclusions:
The test substance produced a maximum group mean score of 17.0 and was classified as a moderate irritant (Class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
Executive summary:

No corneal effects were noted during the study. Iridial inflammation was noted in all treated eyes one hour after treatment. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24-hour observation with minimal to moderate conjuntival irritation noted in all treated eyes at the 48-hour observation and minimal conjuntival irritation noted in all treated eyes at the 72-hour observation.