Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 Aug 2014 - 17 Oct 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Species/strain : Yac:NZW(KBL), Rabbit, SPF
Sex : 3 males
Age and body weight : About 3 months old, 2079.1 - 2328.3 g

ENCIRONMENTAL CONDITIONS
Temperaure : (21.2-22.6)℃
Relative humidity : (62.4 - 66.1)% R.H.
Air exchange : (10-20)/h
Light cycle : Light 12h (08:00 - 20:00)
Dark 12h(20:00 - 08:00)
Illumination : (150 - 300)Lux
Cage style : stainless steel cage
Cage size : (470W * 405D * 600H)mm
rabbit per cage : 1 rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye
Amount / concentration applied:
The test substance was applied as a volume of 0.1 g/animal
Duration of treatment / exposure:
Single application
Observation period (in vivo):
Observations were made after 1, 24, 48, 72 hours after application
Number of animals or in vitro replicates:
3
Details on study design:
- Topical ocular anesthetic : 0.5 % proparacaine hydrochloride(Alcon-conuvreur, Belgium) were applied to each eye

- Test substance was applied to the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball.

- Observations : Clinical signs, Body weight, Observation of eye reactions, Evaluation eye of reactions

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
Degree of opacity
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Diffuse of opacity
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No clinical signs and mortality were observed relating to test substance treatment. All tested animals showed normal gains in body weight. After application of test substance, eye corrosion was not observed in any of the treated animals. Eye irritations such as some blood vessels hyperaemic and some swelling above normal were observed after administration of 1 hour and 24 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
According to the criteria for the evaluation of eye reactions specified by the GHS, the present observation provides no evidence of either corrosion or irritation. Red 620 on eye application of NZW rabbit was classified as "Non-irritant"