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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11th June 2018 to 7th January 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Acute Dermal Irritation / Corrosion (404) published by the Ministry of Environmental Protection of Peoples Republic of China in the year 2013
GLP compliance:
yes

Test material

Test animals

Species:
rabbit
Strain:
other: Japanese white
Details on test animals or test system and environmental conditions:
Source: Qingdao Kangda Biological technology Limited company
A physical check up was carried out on all animals on arrival. Animals were acclimatised for 7 days and housed individually in Room A115. All animals were weighed and marked on the hair. Clinical observations were performed daily. Animals were raised in suspended stainless steel cages.
Temperature: 17-23oC
Humidity: 40-70%
Light sequence: 12 hour light / 12 hour dark
Food: Rabbit maintenance feed (Beijing keaoxieli Feed Co. Ltd.)
Water: ad libitum

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: Corn Oil
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5g of test item moistened completely with 0.8ml vehicle
Duration of treatment / exposure:
4 hours
Observation period:
The skin sites were examined 1, 24, 48 and 72 hours after removal of patches.
Number of animals:
3
Details on study design:
0.5g of the test item was applied uniformly to the gauze patch which was a non-irritating adhesive type. The treated patch was placed on the right side of the clipped area and then covered by medical film. All animals were wrapped using elastic bandage and medical tape to form a semiocclusive dressing which gave good contact with the skin and prevented ingestion or inhalation of the test item. The left side was considered a control. Patches were removed after 4 hours. The residual test item was gently wiped off by cotton moistened with tepid water.
The skin sites were examined 1, 24, 48 and 72 hours after removal of patches for signs of skin reaction and symptoms. Dermal reactions for erythema /eschar or oedema of test sites of each animal were scored and recorded. Other local reactions and systemic side reactions were also described and recorded. Mean scores were calculated. The test item was classified according to GHS criteria for Acute Dermal Irritation / Corrosion.

Results and discussion

In vivo

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

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the above results, E Stage 3 intermediate did not cause an irritation reaction in rabbits and was classified as 'unclassified' according to GHS classification criteria for skin irritation.
Executive summary:

The study was performed to assess the acute dermal irritation/corrosion of E Stage 3 intermediate in Japanese White rabbits. The method was designed to be in accordance with the guidelines for the testing of chemicals 'Acute Dermal Irritation/Corrosion' (404) published by the Ministry of Environmental Protection of People's Republic of China in the year 2013. 


Three male rabbits were used for the study. A quantity of 0.5g of the 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 1, 24, 48 and 72 hours after patch removal. All local toxic effects on skin as well as systemic toxicity were also fully described and recorded. Dermal reactions (erythema/eschar and oedema of test sites were scored at approximately 24, 48 and 72 hours after patch removal. Mean scores of erythema/eschar or oedema at 24, 48 and 72 hours were calculated for tested skins after patch removal. Individual animal body weights were recorded on the day of dosing and on the completion of fiinal observations.


No abnormal signs or symptoms were observed in any animal throughout the course of the test. The scores of erythema/eschar and oedema for all animals at approximately 24, 48 and 72 hours were all 0 after patch removal. All animals showed expected gain in bodyweight during the study. 


Based on the above results, E Stage 3 intermediate was considered to have no irritant effects on the skin of rabbits was classified as 'unclassified' according to GHS classification for eye irritation.