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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
Study period:
30/10/2018 - 19/11/2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: Japanese White (Jla:JW)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
Single administration followed by closing the eyelid for 1 second.
Observation period (in vivo):
1, 3 and 6 hours after treatment, for 4 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the above results, HCFO-1233yd(Z) showed no corrosion to rabbit eye and it was judged as "Mildly irritating" and regarded as ''Not classified" according to the GHS classification under the conditions of this study.
Executive summary:

The eye irritation/corrosion potential of the HCFO-1233yd(Z) (the test substance) was examined in Japanese White rabbits (lla:JW, female). The test substance (0.1 mL) was applied to the left eye of one (initial test) and two animals ( confirmatory test), and the eye reactions were observed for the longest 96 hours after application and the eye corrosion/irritation potential was evaluated. The results are summarised as follows:

There were no corrosive changes in any animal during the observation period. Conjunctival redness, chemosis and discharge were observed in 3/3 or 2/3 animals at 1 hour after application. Eye irritation reactions were alleviated with the passage of time and all changes disappeared by 96 hours after application. The maximum mean total score (MMTS) was recorded at 1 hour after application and the value was 7.3. In the evaluation by the Kay and Calandra classification, the value of mean total score at 48 hours after application (MTS 48) was 0.7 and higher than 0, thus the test substance was classified as "Mildly irritating". In the evaluation of irritation by the GHS classification criteria, the test substance was regarded as ''Not classified" since there were no animals that showed positive response for corneal opacity (degree), iritis, conjunctival redness or chemosis. There were no abnormalities in clinical signs or body weight of any animal.

Based on the above results, HCFO-1233yd(Z) showed no corrosion to rabbit eye and it was judged as "Mildly irritating" and regarded as ''Not classified" according to the GHS classification under the conditions of this study.