Hexane-1,3,6-tricarbonitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2022.07.08-2022.09.28

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 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

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

Species:

rabbit

Strain:

New Zealand White

Remarks:

SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SAMTAKO BIO KOREA
- Age at study initiation: 10 weeks
- Weight at study initiation: 2005.2-2041.6g
- Housing:Quarantine room 1
- Diet (e.g. ad libitum): libitum
- Water (e.g. ad libitum):libitum
- Acclimation period:3days in quarantine room, 5days in animal room

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.4 ~ 20.3 ºC
- Humidity (%): 53.7 ~ 67.9 %
- Air changes (per hr): 10 ~ 15 air exchanges / hour
- Photoperiod (hrs dark / hrs light):12 hours light / 12 hours dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Remarks:

24 hours before administration of the test substance, the hair on the back of the rabbit was shaved to an area of about 15 cm x 15 cm using an electric hair remover to make healthy skin that has not been damaged.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

site A: 3 min
site B: 1 hour
site C: 4 hour

Observation period:

14 days

Number of animals:

1 in initial test
2 in confirmatory test

Details on study design:

TEST SITE
- Area of exposure: back
- % coverage: 6 cm²
- Type of wrap if used: a gauze patch, which was held in place with non-irritating tape. The entire trunk of the animals were wrapped with non-toxic adhesive tape (Tegaderm, 3M, U.S.A.) and carefully rinsed with sterilized distilled water to remove the residual test substance

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4-14 days

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4-14 days

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

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.
No abnormal body weight changes were observed in initial or confirmatory tests.

As a result of observing skin reactions after administration of the test substance, no erythema/eschar formation and oedema were observed in both the initial test and the confirmatory test. The skin reaction score was calculated as 0.0 in both the initial test and the confirmatory test. The skin reaction score was calculated as 0.0 in control sites.

As a result, 1,3,6-Hexanetricarbonitrile was classified as “non-irritating” according to GHS "No category" due to no skin corrosion and irritation.

Executive summary:

This study was conducted to observe acute dermal irritation/corrosion of 1,3,6-Hexanetricarbonitrile in female New Zealand White rabbit and to determine the degree of irritation by calculating the skin reaction score. In order to determine the irritation/corrosion potential, three patches of test substance (0.5 mL) were sequentially applied for 3 mins, 1 hour and 4 hours, to approximately 6 cm2 of shaved skin on the dorsal area of one rabbit (occlusive exposure) during the initial test. After exposure, the test site was wiped with sterilized distilled water. According to the guideline criteria for grading of skin reactions, no evidence of erythema/eschar formation and oedema were observed after 4 hours, and therefore the confirmatory test was conducted. In the confirmatory test, the test substance (0.5 mL) was applied to two rabbits for 4 hours. The patch with the test substance was applied to the left site, and nothing was applied to the right site, as a control site. All animals were monitored for clinical signs and skin reaction during the 14 days observation period after administration.
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 skin reactions after administration of the test substance, no erythema/eschar formation and oedema were observed in both the initial test and the confirmatory test. The skin reaction score was calculated as 0.0 in both the initial test and the confirmatory test. The skin reaction score was calculated as 0.0 in control sites. As a result, 1,3,6-Hexanetricarbonitrile was classified as “non-irritating” according to GHS "No category" due to no skin corrosion and irritation.