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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
EPA 40 CFR parts 792 and 160, FDA 21 CFR 58

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): c-4000
- Physical state: liquid
- Analytical purity: >99%
- Purity test date: 2007-02-26
- Lot/batch No.: jyc0367
- Expiration date of the lot/batch: 2007-08-26
- Stability under test conditions: stable
- Storage condition of test material: room temperature and humidity

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye served as control
Duration of treatment / exposure:
The test article (0.1 mL) was placed into the conjunctival sac of one eye. Both eyes were washed with saline after 24 hour.
Observation period (in vivo):
Both trated and untreated eyzq were examined and scored at 1,24,48 and 72 hours postdose.
Number of animals or in vitro replicates:
3: 1 female and 2 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24,48,72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24,48,72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24,48,72 hours
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24,48,72 hours
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Other effects:
There were no abnormal physical signs noted during the observation period.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
C-4000 is an ocular irritant in rabbits however not classified according to EEC criteria.
Executive summary:

In a primary eye irritation study , 0.1 mL of   C-4000 (>99%% a.i.) was instilled into the conjunctival sac of New Zealand white rabbits (1 female, 2 males) eye for 24 hours.  Eyes were washed after 24 hours.  Animals then were observed for 3 days.  Irritation was scored by the method of Draize JH in J. Pharm. Exp. Ther. 82 :377 -390,1944.  

Only conjunctival irritation, noted in 3/3 eyes occured and cleared by 48 hours.   In this study, C-4000 is minimally irritating to the eye to the eye based on EU criteria.