Registration Dossier

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:
07-2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-{2-[(2-ethylhexyl)oxy]ethoxy}ethyl prop-2-enoate
Cas Number:
117646-83-0
Molecular formula:
C15H28O4
IUPAC Name:
2-{2-[(2-ethylhexyl)oxy]ethoxy}ethyl prop-2-enoate
Test material form:
liquid
Details on test material:
Test substance name: MI RAMER M1086
Appearance : Clear liquid
Manufacturing date: 2012-03-29
Supplier:Miwon Specialty Chemical Co., Ltd.
Receipt day: 2012-05-23
Deli very amount: 399.223 g(Gross)
Cas No.:117646-83-0
Lot No.:120329JY1
Purit y: 95.55 %
Expiration date: 2013-03-28 (Manufactured after 1 year)
Storage condition: Room temperature [(15 ~ 25)°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Animal strain and species : Yac:NZW(KBL), Rabbit, SPF
Supplier : Cheonan Yonam college (Sunghwan-up, Seobuk-gu, Chungnam, 331-709, KOREA)
No. of animals and sex distinction at the time of receipt : 4 males
A range of age and body weight at the time of receipt : about 3 months old, 1884.0 ~ 2273.6 g

No. of animals and sex distinction at the time of administration : 3 males
A range of age and body weight at the time of administration : about 3 months old, 2136.6 ~ 2418.9 g
Choice of test system
NZW rabbits are commonly used for this type of acute dermal irritation and corrosion study, and there are plenty of reference data.
Quarantine and acclimation
On receipt the animals any signs of health or injury were examined. The animals were acclimated for five days when their health statuses were assessed. For study, the animals were used after examined body weight changes and healthy condition.
Identification
Identification cards including information such as study number, test substance name, test title, receipt date, quarantine period, allocation date, experimental period, sex, group number and study director's name.
Remained animal
After animal allocation, a remained animal was euthanized.

Environmental conditions [Rabbit room No. 2]
The animal room environment was controlled as follows : [temperature (20 ± 3) ℃,relative humidity (50 ± 20) %, the rate of air exchange was at least (10 ~ 15) times per hour and lighting was automatically controlled to provide 12 hours of artificial light (08:00 ~ 20:00 hours, 150 ~ 300Lux)]. The feed and water were supplied for acclimation and test period.
Environmental monitoring
The temperatures and relative humidities were continuously monitored per 30 minutes by a computerized system. The luminous intensity, ammonia concentration and noise of animal room measured once per quarter periodically. The environmental conditions were considered not to have affected the purpose or integrity of the study.
Housing
The animals were housed in stainless steel cages [380(W) ㎜ × 480(D) ㎜ × 300(H)㎜, Jeongdo Ltd., Korea].
Diet and water
The animals were fed pellet diet for rabbit (Cargill Agri Purina, Inc., 56-4, Soryong-dong, Gunsan-si, Jeonbuk, Korea) and given the filtered and UV irradiated
water ad libitum .

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.5 mL/site of prepared test substance was applied to a small area (approximately 6 cm2)
Duration of treatment / exposure:
4 hrs
Observation period:
All animals were daily observed for clinical signs and survival for 72 hours after application of test substance.
Animals were recorded the appearance of each application site at 1, 24, 48 and 72 hours according to Grading of dermal lesions.
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The present study, to investigate the dermal irritation and corrosion of MIRAMER M1086 was conducted with NZW rabbits. The test substance was applied to the skin of NZW rabbits for 4 hours. Parameters measured during 72 hours observation period were mortality, clinical signs, body weight changes and local irritation.
No mortality was observed in the present study and no treatment-related clinicalsigns were observed in any treated animals. All tested animals showed normal gains in body weights. After application of test substance, the dermal irritation was shown erythema. Skin irritation was observed in very slight erythema until 72 hours. However, from the fourth day after application of the test substance in the healing process was the formation of keratin. The dermal irritation of two animals were restored to normal within one animal 9 days and another animal 10 days.

Based on these results, the test substance (MIRAMER M1086) was considered to be non-irritant in this study.
Executive summary:

The acute dermal irritation potential of MIRAMER M1086 was investigated according to NIER Notification No. 2010-29. The test substance was applied by topical semi-occlusive application of 0.5 mL to the intact skin of the left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. Parameters measured during 72 hours observation period were mortality, clinical

signs, body weight changes and local irritation.

- No mortality was observed in the present study.

- No treatment-related clinical signs were observed in any treated animals.

- All tested animals showed normal gains in body weight.

- After application of test substance, the dermal irritation was shown erythema.

- National Institute of Environmental Research (NIER) Notification No. 2010-25 (August 27, 2010), Korea and Globally Harmonized System of Classification and Labelling of Chemicals (GHS), test substance would not be classified as an dermal irritant.