Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2018-06-21 to 2018-06-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2015
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Purity: > 99%
Batch No.: 102Z4

Test animals

Species:
rabbit
Strain:
other: Japanese White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Qingdao Kangda Biological Technology Limited Company
- Age at study initiation: 84 days at arrival and 90 - 91 days at dosing
- Weight at study initiation: 2112.3-2486.1 g at dosing
- Housing: in stainless steel cages (W 70 cm × L 80 cm × H 75 cm)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 -7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2 - 20.9 °C
- Humidity (%): 47% - 72%
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: Ultra-purified water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm × 2.5 cm
- Type of wrap if used: elastic bandage and medical paper tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the residual test substance was gently wiped off the application site by cotton moistened with tepid water.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- Clinical Observations: once daily throughout the study
- Skin Reactions Examination: at approximate 1, 24, 48 and 72 hours after patches removal
- Body Weights: within 24 hours after arrival, on the day of dosing and on the completion of the final observations of dermal irritation symptoms

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
mean of three males
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
mean of three males

Any other information on results incl. tables

Inidividual skin reactions grading:

Animal ID Skin reactions 1 h 24 h 48 h 72 h
1100 Erythema/Eschar 0 0 0 0
Oedema 0 0 0 0
1101 Erythema/Eschar 0 0 0 0

Oedema

0

0

0 0

1102

Erythema/Eschar 0 0 0 0
Oedema 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was considered to have no irritations to skin in rabbits.
Executive summary:

The study was performed to assess the acute dermal irritation/corrosion of the test substance in Japanese White rabbits in accordance with OECD Guideline for the testing of chemicals: Acute Dermal Irritation/Corrosion (TG 404, adopted July 28, 2015).

Three male rabbits were used for the study. A quantity of 0.5 g test item was applied to the right side of back skin of each animal for an exposure period of 4 hours. The untreated skin on the left back area of the animal served as the control. Clinical signs were performed once daily throughout the study. The skin sites of each animal for signs of erythema/eschar and oedema were all recorded immediately, and at approximate 1, 24, 48 and 72 hours after patch removal, and all local toxic effects of skin were also fully described and recorded. Individual animal body weights were recorded on the day of dosing and on the completion of final observations of dermal irritation symptoms.

 

No abnormal signs or symptoms were observed in all animals throughout the course of the study. There were no observable abnormalities for three control sites in skin reaction examinations at all observation intervals after patches removal. There were no observable abnormalities for three test sites in skin reaction examinations at approximate 1, 24, 48 and 72 hours after patches removal of the test item. All animals showed expected gains in body weights during the course of the study.

Based on above results, the test substance was considered to have no irritations to skins in rabbits, and was classified as unclassified according to GHS's classification criteria for the skin irritation.