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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:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of diphenyl ether and 9-methylene nonadecane
EC Number:
943-303-1
Molecular formula:
Variable, substance is a UVCB
IUPAC Name:
Reaction products of diphenyl ether and 9-methylene nonadecane
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
Yac: NZW (KBL)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Cheonan Yonam college
- Age at study initiation: 3 months
- Weight at study initiation: 2086.5 to 2283 g
- Housing: Stainless steel cage containing one rabbit
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Acclimatised for 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 to 21.7
- Humidity (%): 55.2 to 62.6
- Air changes (per hr): 10 to 20
- Photoperiod (hrs dark / hrs light): 12 hours light 12 hours dark

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/site

Duration of treatment / exposure:
Upto 4 hours in the initial animal (3 patches were applied sequentially with these removed after 3 minutes, 1 hour or 4 hours).
The two following animals were treated for 4 hours as no effects were observed in the initial animal.
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2 x 3 cm
- Type of wrap if used: Gauze held in place by non-irritating tape and occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Carefully washed with sterilised water
- Time after start of exposure: Between 3 minutes and 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): See duration of treatment/exposure

SCORING SYSTEM:
- Method of calculation: Table taken from OECD 404 guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal: 1, 2 and 3
Time point:
72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No skin reaction were observed
Other effects:
No mortality or effects on clinical signs, bodyweight or skin reactions were observed in any animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
After application of the test material to 3 rabbits, no evidence of dermal irritation or corrosion was observed and accordingly the substance is not classified under UN GHS criteria or the CLP regulation.