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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
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:
1992
Report date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: 29 CFR 1910-1200 and 16 CFR 1500.41
Principles of method if other than guideline:
The test was conducted based on US OSHA, 29 CFR, 1910.1200 and 16 CFR 1500.41
GLP compliance:
yes

Test material

Constituent 1
Test material form:
liquid
Details on test material:
Yellowish Brown Liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Six healthy, young adult, 3 male and 3 female rabbits were used in the study.
Animals were purchased from a registered commercial breeding laboratory (Eastern Rabbit Breeding Laboratory, Taunton, MA)
Animals weighed between 2.0-3.0 kg
Animals were individually housed in seperate suspended cages.
Rooms were maintained at 68 degrees F.
12 hour dark/light periods were provided.
Animals were supplied with commercial rabbit ration and tap water ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A dose of 0.1 mL was administered to each animal
Duration of treatment / exposure:
Animals were checked for signs of irritation 24 hours after the substance was applied to the eye, and the eye was rinsed of any leftover test material.
Observation period (in vivo):
Observation occured 24 hours after application of substance
Duration of post- treatment incubation (in vitro):
After observation at 24 hours, the eyes were checked again at 48 and 72 hours.
Number of animals or in vitro replicates:
6 total animals were used in the study

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
6
Max. score:
110
Reversibility:
not specified
Remarks on result:
no indication of irritation

Any other information on results incl. tables

One of the six rabbits was shown to have a positive conjunctival erythema result. The test substance is considered non-irritating to the eyes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was tested in an eye irritation assay in rabbits and found to be non-irritating.