α-phenyl-1H-benzimidazole-2-methanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 Oct 2016 - 31 March 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study was conducted in accordance with international guidelines and in accordance with GLP. All relevant validity criteria were met.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

α-phenyl-1H-benzimidazole-2-methanol

EC Number:

200-073-0

EC Name:

α-phenyl-1H-benzimidazole-2-methanol

Cas Number:

50-97-5

Molecular formula:

C14H12N2O

IUPAC Name:

α-phenyl-1H-benzimidazole-2-methanol

Test material form:

solid

Details on test material:

Storage Conditions:Stable at ambient temperature (10-30°C). Store in darkness; may be used/formulated in light.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Product Inc, Denver, PA
- Females (if applicable) nulliparous and non-pregnant:Not stated
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 2.8 - 2.9 kg
- Fasting period before study: not specified
- Housing: individually housed in suspended wired-bottom cages, absorbent paper was changed at least three times per week.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet No. 5321)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not stated
- Humidity (%): Not stated
- Air changes (per hr): Not stated
- Photoperiod (hrs dark / hrs light): 12 : 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: Corn oil

Remarks:

test item was moistened with 0.5 ml of corn oil

Controls:

no

Amount / concentration applied:

0.5 g per site

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 & 72 hours

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0.4

Max. score:

4

Reversibility:

other: Absent

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Absent

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Absent

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Absent

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Absent

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Absent

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Absent

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

DOT: Not corrosive

Any other information on results incl. tables

Table 3. Results and Discussion

No. of animals	Dermal Responses(Timing post- exposure)	Erythema	Edema	Additional Observations
Three Minutes Exposure
1	0 Minute	Absent	Absent	None
	60 Minutes	Absent	Absent	None
One Hour Exposure
2	1-hour	Absent	Absent	None
	24-hour	Absent to very slight	Absent	None
	48-hour	Absent	Absent	None
	72-hour	Absent	Absent	None
Four Hours Exposure
3	1-hour	Very slight	Absent to very slight	None
	24-hour	Absent	Absent	None
	48-hour	Absent	Absent	None
	72-hour	Absent	Absent	None
Systemic Observation		No abnormal physical signs were observed among all three animals.
Body weight		Two animals gained weight and one study animal lost weight by study termination.
Conclusions
Primary Irritation Index (PII) =0.4Response Category:Practically Non-irritating (Negligible) DOT:Not corrosive, NoEPA:NotGHS:Not packing group assignment Classified Classified

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the consition of the study, the primary irritation index (PII) of the test item was 0.4, following exposure to clipped rabbit skin under semi-occlusive condition. The test item does not meet the criteria for classification according to the Globally Harmonized Classification System and to the Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixture.

Executive summary:

OECD 404 (2016) -the irritant or corrosive effects of the test article was assessed following application to the clipped skin of white New Zealand rabbit. The test article (0.5 g) was applied dermally to Site 1 for exposure period of 3 minutes under occlusive patch. Since the reaction of the initial animal did not produce a corrosive or severely irritating effect, two additional animals (one female and one male) were added to the study. All three animals were dosed at Site 2 for an exposure period of one hour and Site 3 for an exposure period of four hours. Erythema and edema were scored at 1, 24, 48 and 72 hours after patch removal for the one and four-hour exposures. Animals were observed for mortality, toxicological and pharmacological effects at least once daily. Body weights were recorded pre-test and at termination.

No abnormal physical or systemic signs were observed among all three animals. Two animals gained weight and one study animal lost weight by study termination. No mortality reported.

Very slight erythema and oedema was noted within 24 hours post exposure and it was fully reversible. The Primary Irritation Index (PII) of theist item was reported as 0.4.

Under the condition of the study, it was concluded that test item was not corrosive and does not cause irritation to the rabbits’ skin. Therefore, the test item does not meet the criteria for classification according to the Globally Harmonized Classification System and to the Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixture.