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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2019-06-03 to 2019-06-07
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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2015
Deviations:
yes
Remarks:
Housing room temperature and humidity has small deviations from Guideline, but not affect the quality and integrity of the study.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetravinylsilane
EC Number:
214-192-0
EC Name:
Tetravinylsilane
Cas Number:
1112-55-6
Molecular formula:
C8H12Si
IUPAC Name:
tetravinylsilane
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
other: Japanese white
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Shenyang Tenghua Biotechnology Co., Ltd.
- Age at study initiation: 97-108 days
- Weight at study initiation: 2344.6-2407.8 g
- Housing: individually raised in suspended, stainless steel cages (W 40 cm× L50 cm×H40 cm) on cage racks (L167 cm×W70cm×H171 cm)
- Diet: pellet rabbit diet, ad libitum
- Water: ad libitum
- Acclimation period: 7-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4-25.1
- Humidity (%): 49-77
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 mL test item
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
Initial Test: 1
Confirmatory Test: 2
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm× 2.5 cm
- Dosing: A dose 0.5 mL of the test item was applied to the gauze patch (2.5 cm × 2.5 cm). The test and control patches were applied to the appointed and depilated skin.
- Type of wrap: All animals were wrapped using elastic bandage and medical paper tape to form a semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: Patches were removed at the end of the exposure period. The residual test substance was gently wiped off the application site by cotton moistened with tepid water. Care was taken not to alter the existing response or the integrity of the epidermis.
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
- Clinical Observations:
All animals were observed for clinical signs once daily throughout the study.
- Skin Reactions Examination:
The skin sites of each animal were examined and recorded for signs of skin reaction immediately, at approximately 1, 24, 48 and 72 hours after patch removal.
- Body Weights:
Individual animal body weights were recorded within 24 hours after arrival, on the day of dosing and on the completion day of the final observation of dermal irritant symptoms.

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2 & #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #1, #2 & #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
The test item sites did not show any evidence of adverse skin reactions such as erythema and oedema immediately, at approximately 1, 24, 48 and 72 hours after patch removal of the test item.
There was no observable abnormality in skin reaction examinations for three control sites at all observation intervals after patch removal of the test item.
Other effects:
- Clinical Observations:
No abnormal signs or symptoms were observed in three animals throughout the course of the study.
- Body Weights:
The body weights of all animals showed growth trends during the observation periods.

Any other information on results incl. tables

Skin Reactions Grading:

No.

Erythema

Oedema

24h

48h

72 h

Mean

24h

48h

72 h

Mean

1100

0

0

0

0

0

0

0

0

1101

0

0

0

0

0

0

0

0

1102

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was considered to not be irritating to skins in rabbits.
Executive summary:

The study was performed to assess the acute dermal irritation/corrosion of test item in rabbits in accordance with OECD 404.

Three male rabbits were used for the study. 0.5 mL of 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.

No abnormal signs or symptoms were observed in three animals throughout the course of the study.

The body weights of all animals showed growth trends during the observation periods.

Individual scores of erythema/eschar and oedemas were all 0 for three treated sites at 1, 24, 48 and 72 hours after patch removal. The mean scores of erythema/escharand oedemasat24,48 and 72 hourswereall0 for threetestsitesafter patch removal.

The test item was considered to not be irritating to skins in rabbits.