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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

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
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
During the test period, the temperature and humidity of the animal room were recorded with measured data every 1 hours by an automatic temperature and humidity meter in every 5 min intervals.

Test system

Type of coverage:
open
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
up to 72 hr
Observation period:
3 min, 1, 4, 24, 48 and 72 hr
Number of animals:
3
Details on study design:
1. Room No.: Rabbit room 1
2. Cage type and size: Stainless steel cages (W 420 x L 270 x H 180 mm)
3. Animals per cage: 1 animal
4. Temperature: 18.1 ~ 20.6ºC
5. Relative humidity: 49.1 ~ 60.2%
6. Air exchange: 10 ~ 15 / hr
7. Light cycle: 12 hr light / 12 hr dark
8. Illumination: 150 ~ 300 lux

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
1. As a result of observing the test substance administration site, skin irritation and corrosiveness were not observed in all the test substance the administration and control sites.
2. Evaluation of skin irritation scores at 24, 48 and 72 hours after administration of test substance resulted in a skin irritation score of "0.0" for erythema & edema and edema in all animals.
Other effects:
1. No mortality was observed in this study.
2. No treatment-related clinical signs were observed in any treated animals.
3. All tested animals observed normal gains in body weights.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
It was judged that it was not classified as according to CLP.