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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

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

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
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
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

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
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4-14 days
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4-14 days
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
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.

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Justification for type of information:
This in vivo study was performed to fullfill the information requirement of China and Korea authorities, it is generated before EU REACH registration .
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
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

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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification