Prop-2-yn-1-yl 1H-imidazole-1-carboxylate

Endpoint summary

Description of key information

Based on the results of the experiment, it is concluded that single dermal application of prop-2-yn-1-yl 1H-imidazole-1-carboxylate did not reveal any skin reactions when applied to the skin of New Zealand White Rabbits, hence the test item is considered as non-irritant and did not meet the classification criteria according to the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2022

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted on 28 July 2015

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Physical appearance (with colour): White solid
Purity (as per Certificate of Analysis): 99.7789%
Lot No.: S021110385
Date of Manufacture: 2021.11.3
Date of Expiry: 2023.5.6
Storage Conditions: Cool and dry (+2 to +8ºC)

Species:

rabbit

Strain:

New Zealand White

Remarks:

Oryctolagus cuniculus

Details on test animals or test system and environmental conditions:

Test System
No. of Animals / Test and Sex: Initial Test : 1 Female
Confirmatory Test : 2 Females
(Females used were nulliparous and non-pregnant)
Age at Receipt: 4 to 5 months
Body Weight at Receipt: 2.28372 kg to 2.33094 kg
Animal Identification: Acclimatization period: Cage cards
Treatment period: Cage cards and last 4 digits of the animal number were
written on the ear of each rabbit using black marker pen.
Animal No’s: Nc3676 to Nc3678
Husbandry
a. Environmental Conditions:
Animals were housed under standard laboratory conditions, in an environmentally monitored air-conditioned room with adequate fresh air supply (12 to 15 air changes per hour), room temperature 19.7°C to 22.7°C and relative humidity 48% to 64% with 12 hours fluorescent light and 12 hours dark cycle. The temperature and relative humidity were recorded once daily.
b. Housing:
The animals were housed individually in stainless steel wire mesh cage (Size: L 24 x B 18 x H 18 inches) having facilities for holding pelleted feed and drinking water.
c. Feed:
Altromin Maintenance diet for rabbits – Rich in crude fibre 2123 manufactured by Altromin Spezialfutter GmbH & Co. KG was provided ad libitum to the rabbits throughout the experimental period.
d. Water:
Water was provided ad libitum throughout the experimental period. Deep bore-well water passed through Reverse osmosis unit was provided in plastic water bottle with stainless steel sipper tubes.
Acclimatization:
Healthy young adult animals used for initial test and confirmatory test were acclimatized for a period of six and thirteen days respectively to experimental room conditions prior to treatment and were observed for clinical signs once daily. Veterinary examination of all the animals was performed on the day of receipt.
Preparation of Animals
Approximately 24 hours before the application of the test item, fur on the dorso-lateral area of the trunk of the animals was removed by clipping closely using an electric hair clipper (approximately 8 cm x 12 cm). Care was taken to avoid abrasion to the skin and the animals with healthy intact skin were used.

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

yes, concurrent negative control

Amount / concentration applied:

0.5 g of test item was moistened with 0.5 mL of distilled water

Duration of treatment / exposure:

Initial Test: the test patches were applied for 3 minutes, 1 hour and 4 hours respectively.
Confirmatory Test: the test patch was applied for 4 hours exposure period.

Observation period:

Initial test: The application sites 2 and 3 were scored immediately after patch removal whereas the application sites 1 and 4 were scored immediately after patch removal and approximately at 1, 24, 48 and 72 hours after the patch removal.
Confirmatory test: The application sites 1 and 2 were scored approximately at 1, 24, 48 and 72 hours after patch removal.

Number of animals:

Initial Test : 1 Female
Confirmatory Test : 2 Females

Details on study design:

The study was performed in two phases i.e., initial test and confirmatory test. Initial test was performed using one rabbit, there were no corrosive or irritant effects observed in initial test. Hence, the confirmatory test was performed by using two additional rabbits.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

0: No Erythema/Oedema

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

0: No Erythema/Oedema

Other effects:

No clinical signs of toxicity and mortality were observed in any of the animals in initial test and confirmatory test.
No skin reactions like erythema and oedema were observed in any of the animals in initial test and confirmatory test.
No treatment related changes were observed in body weight and percent change in body weight with respect to day 1 in initial test and confirmatory test animals. All animals revealed normal increase in the body weight during the observation period.

INDIVIDUAL ANIMAL SKIN REACTIONS SCORING RECORD

Phase of the Experiment	Animal No.	Sex	Exposure   Duration	Application Site	Dose (g/Patch)	Observations	Skin Reactions Score after Patch Removal					Mean Score
							IAR	1 hr	24 hrs	48 hrs	72 hrs
Initial Test	Nc3676	Female	3 min	Site 2	0.5	ERY	0	-	-	-	-	-
						EDE	0	-	-	-	-	-
			1 hrs	Site 3	0.5	ERY	0	-	-	-	-	-
						EDE	0	-	-	-	-	-
			4 hrs	Site 1	Untreated Control	ERY	0	0	0	0	0	0
						EDE	0	0	0	0	0	0
			4 hrs	Site 4	0.5	ERY	0	0	0	0	0	0
						EDE	0	0	0	0	0	0
Confirmatory Test	Nc3677	Female	4 hrs	Site 1	Untreated Control	ERY	-	0	0	0	0	0
						EDE	-	0	0	0	0	0
				Site 2	0.5	ERY	-	0	0	0	0	0
						EDE	-	0	0	0	0	0
	Nc3678	Female	4 hrs	Site 1	Untreated Control	ERY	-	0	0	0	0	0
						EDE	-	0	0	0	0	0
				Site 2	0.5	ERY	-	0	0	0	0	0
						EDE	-	0	0	0	0	0

ERY: Erythema; EDE: Oedema; 0: No Erythema/Oedema; min: Minutes; hr/hrs: Hour/Hours; IAR: Immediately after removal of the test patch; - : Not Applicable

Mean Score For Erythema/ Oedema	:	24 hrs + 48  hrs+ 72 hrs (Observations after patch removal)
		3 (Observation time point)

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the experiment, it is concluded that single dermal application of prop-2-yn-1-yl 1H-imidazole-1-carboxylate did not reveal any skin reactions when applied to the skin of New Zealand White Rabbits, hence the test item is considered as non-irritant and did not meet the classification criteria according to the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals.

Executive summary:

The test item prop-2-yn-1-yl 1H-imidazole-1-carboxylate was evaluated for Acute Dermal Irritation/Corrosion in New Zealand White rabbits.

The study was performed in two phases i.e. initial test and confirmatory test. Approximately 24 hours before the application of the test item, fur on the dorso-lateral area of the trunk of the animals was removed by clipping closely using an electric hair clipper (approximately 8 × 12 cm). The clipped area of skin at left trunk region and right trunk region was divided into four application sites and it was identified as application sites 1, 2, 3 and 4 respectively.

The application site 1 (anterior left trunk region) of the animal was served as untreated control. On application site 2 (posterior left trunk region), site 3 (posterior right trunk region) and site 4 (anterior right trunk region) of the animal, 0.5 g of test item moistened with 0.5 mL of distilled water was applied for 3 minutes, 1 hour and 4 hours respectively. The application sites 2 and 3 were scored immediately after patch removal whereas the application sites 1 and 4 were scored immediately after patch removal and approximately at 1, 24, 48 and 72 hours after the patch removal.

As there was no corrosive effects observed during initial test, the confirmatory test was performed using two additional rabbits. In the confirmatory test, the patches were applied for 4 hours exposure period. Each animal had two application sites. The clipped area of skin at left trunk region and right trunk region were identified as application sites 1 and 2 respectively.

In the confirmatory test, the application site 1 (left trunk region) of each animal was served as untreated control covered with blank cotton gauze. On application site 2 (right trunk region) of each animal, 0.5 g of test item moistened with 0.5 mL of distilled water was applied for 4 hours exposure period and removed after 4 hours. After removal of the test patches, the application sites were washed with distilled water and dried with absorbent cotton without altering the existing response or the integrity of the epidermis. The application sites 1 and 2 were scored approximately at 1, 24, 48 and 72 hours after patch removal.

The mean score across 3 scoring times (24, 48 and 72 hours after patch removal) for both initial test animal and confirmatory test animals was ‘0’ for erythema and oedema grades.
No erythema and oedema was observed at the test item application site in initial test animal and confirmatory test animals.

No treatment related clinical signs of toxicity and mortality was observed in initial test animal and confirmatory test animals.

No treatment related changes were observed in body weight and percent change in body weight with respect to day 1 in initial test and confirmatory test animals. All the animals revealed normal increase in the body weight during the observation period.

 

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)