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Diss Factsheets

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:
2022.07.29-2022.09.02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2022
Report date:
2022

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexane-1,3,6-tricarbonitrile
EC Number:
217-199-7
EC Name:
Hexane-1,3,6-tricarbonitrile
Cas Number:
1772-25-4
Molecular formula:
C9H11N3
IUPAC Name:
hexane-1,3,6-tricarbonitrile

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:SAMTAKO BIO KOREA
- Age at study initiation:11 weeks
- Weight at study initiation:2307.9-2412.7
- Housing:Non-rodents 1
- Diet (e.g. ad libitum):libitum
- Water (e.g. ad libitum):libitum
- Acclimation period:3days at quarantine room and 5days at animal room.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18.5 ~ 19.7 ºC
- Humidity (%):51.5 ~ 62.8 %
- Air changes (per hr):10 ~ 15 air exchanges / hour
- Photoperiod (hrs dark / hrs light):12 hours light / 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1 in initial test
2 in confirmatory test

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: all animals
Time point:
other: 1-21 days
Score:
0
Max. score:
0
Reversibility:
other: no adverse effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no adverse effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: all animals
Time point:
other: 1-21 days
Score:
0
Max. score:
0
Reversibility:
other: no adverse effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no adverse effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: all animals
Time point:
other: 1-21days
Score:
0
Max. score:
0
Reversibility:
other: no adverse effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no adverse effect observed
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No clinical signs and dead animals related to the test substance were observed.
As a result of observing eye reactions after administration of the test substance, the ocular mucosal reaction was not observed in the initial test and confirmatory test. As a result of calculating the eye response score, all eye response scores were calculated as 0.0 in the initial test and confirmatory test, and all eye response scores were calculated as 0.0 in the left site where no test substance was administered.
As a result, 1,3,6-Hexanetricarbonitrile was classified as non-irritating according to GHS "No category" due to no eye irritation / corrosion.
Executive summary:

This study was conducted to evaluate acute eye irritation / corrosion of 1,3,6-Hexanetricarbonitrile in female New Zealand White Rabbits, and the average score was calculated to distinguish the degree of response. In order to determine the eye irritation / corrosion potential, it was administered to the ocular mucosa to evaluate acute eye irritation / corrosion and severe eye damage when the test substance was exposed to the eye. There were no abnormal clinical signs or body weight changes observed. According to the guideline criteria for grading of eye reactions, no evidence of cornea and iris and conjunctivae was observed after 1 hour, so a confirmation test was conducted. In the confirmation test, the test substance (0.1 mL) was applied to two rabbits for 1 hours. The other eye, which remained untreated, was responsible for the control site. The animals were observed for 21 days.
The results of this study were as follows.
1) No death of animal was observed during the study period.
2) No clinical signs related to the test substance administration were observed.
3) No abnormal body weight changes were observed in initial and confirmatory tests. 4) As a result of observing eye reactions after administration of the test substance, the ocular mucosal reaction was not observed in the initial test and confirmatory test. As a result of calculating the eye response score, all eye response scores were calculated as 0.0 in the initial test and confirmatory test, and all eye response scores were calculated as 0.0 in the left site where no test substance was administered.
As a result, 1,3,6-Hexanetricarbonitrile was classified as non-irritating according to GHS "No category" due to no eye irritation / corrosion.