2,6-difluorobenzonitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 April 1992 to 17 April 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(see "principles of method if other than guideline" box below)

Principles of method if other than guideline:

Deviations
- The test animals were obtained from a supplier other than stated in the protocol.
- Due to a malfunction of the thermeohygrograph the temperature and the relative humidity in the animal room were not recorded on 12 April 1992.
- The lot number was not given on the test material container but confirmed by an internal memorandum. It therefore was not specified in the raw data.

These deviations were not considered to have affected the integrity of the study performed.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,6-difluorobenzonitrile

EC Number:

217-589-7

EC Name:

2,6-difluorobenzonitrile

Cas Number:

1897-52-5

Molecular formula:

C7H3F2N

IUPAC Name:

2,6-difluorobenzonitrile

Details on test material:

Description: white paste
Storage conditions of test substance: refrigerated

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan CPB, Zeist, The Netherlands
- Age at study initiation:
- Weight at study initiation: 2.5-3.0 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): standard laboratory diet LKK-20, Hope Farms, Woerden, The Netherlands ad libitum
- Water (e.g. ad libitum): ad libitium
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (ºC): 20-21 ºC
- Humidity (%): 20-60 %
- Air changes (per hr): approximately 16
- Photoperiod (hrs dark / hrs light): 12 hrs light (artificial), 12 hours dark

IN-LIFE DATES: From: 14 April 1992 To: 17 April 1992

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- the test material was melted and 0.5g was applied to the patch using a syringe.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours post administration

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 6 cm² patch.
- Type of wrap used: the patch was sustained by occlusive Blenderm tape and secured in place with adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): patches were removed and skin was wiped to remove any remaining test substance.
- Time after start of exposure: 4 hours


SCORING SYSTEM
- The Draize scale (Draize 1959), presented as table 1 in the field "Any other information on material and methods incl. tables" was used to assess the degree of erythema and oedema at the application sites at 30 minutes and at 24, 48 and 72 hours after patch removal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 30 minutes

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 and 72 hours

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 30 mins, 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

Very slight erythema was seen in all animals 30 minutes after application, and in one animal at 24 hours. There were no other signs of skin irritation. All irritation scores are presented in table 2 in the field "Any other information on results incl. tables".

Any other information on results incl. tables

Table 2: Erythema and Oedema Scores

Animal No.	Erythema					Oedema
	Time after decontamination				Mean score	Time after decontamination				Mean Score
	30 min	1 day	2 days	3 days		30 min	1 day	2 days	3 days
1	1	0	0	0	0	0	0	0	0	0
2	1	0	0	0	0	0	0	0	0	0
3	1	1	0	0	0.3	0	0	0	0	0

The mean values have been calculated using the day 1, 2 and 3 values.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the test material did not elicit any reaction in any of the animals during the course of the study and the test material does not require classification as a skin irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.

Executive summary:

The skin irritation of the test material was determined in accordance with the standardised guideline OECD 404. Three rabbits received a single four hour application of 0.5g of the test material and were assessed for at 30 minutes, 24, 48 and 72 hours after treatment for any signs of skin irritation. Very slight erythema was seen in all animals 30 minutes after removal of test material and very slight erythema was seen in one animal after 24 hours. There were no other signs of skin irritation.

Under the conditions of the study, the test material is considered to be practically non-irritating to the skin and does not require classification for skin irritation in line with Regulation No. 1272/2008.