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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye 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 405 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
Yac: NZW (KBL)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Cheonan Yonam college
- Age at study initiation: 3 months
- Weight at study initiation: 2131.2 to 2278.8 g
- Housing: Stainless steel cage containing one rabbit
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 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

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL to the right eye.
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing detailed
- Time after start of exposure: 72 hours

SCORING SYSTEM: As detailed in OECD 405 guideline

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity 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:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No irritative effects were observed
Other effects:
No effects on clinical signs, bodyweight or eye reactions were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
After application of the test substance, to all 3 animals, no eye corrosion or irritation effects were observed in any animals. Accordingly the test substance is not classified with regards to UN GHS and EU CLP.