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Toxicological information

Eye irritation

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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.