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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.