Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014/07/01-204/10/17
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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal 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

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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 : (19.1-19.9)℃
Relative humidity : (54.1-64.1)% 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

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent area to the test site
Amount / concentration applied:
The test substance was applied by topical semi-occlusive application of 0.5 g to the intact skin of 3 young adult New Zealand White(NZW) rabbits.
Duration of treatment / exposure:
Single application for 4 hours
Observation period:
Observations were made after 1, 24, 48, 72 hours after application
Number of animals:
3
Details on study design:
- Hair removal : 24 hours before treatment, fur was removed with electric clippers from an area of roughly (15*15)cm2 on the back of each animal.

- Application of test substance : In each animal, 0.5 g of the test substance which moistened on gauze was applied to the test site [ca. (2*3)cm2 in size], and the adjacent area to the test site served as the control. Each gauze contains test substance was held in place by means of semi-occlusive dressing attaching non-irritating tape (Tegarderm, 3M) and enveloping bandage (Coban, 3M) to the whole of the animal trunk. At the end of the 4 hours exposure period, the dressing was removed and residual test substance was carefully washed away with sterilized distilled water.

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No skin irritation was caused by 4 hours exposure to the test substance.

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 skin reactions specified by the GHS, the present observation provides no evidence of either corrosion or irritation. Red 620 on dermal application of NZW rabbit was classified as "Non-irritant".