Pyridine-2-carbaldehyde oxime

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

in vivo study performed prior to REACH implementation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 - 14 February 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pyridine-2-carbaldehyde oxime

EC Number:

212-849-6

EC Name:

Pyridine-2-carbaldehyde oxime

Cas Number:

873-69-8

Molecular formula:

C6H6N2O

IUPAC Name:

pyridine-2-carbaldehyde oxime

Test material form:

other: crystals

Details on test material:

- Name of test material (as cited in study report) : Pyridin-2-aldoxim
- Physical state : whitish crystals
- Analytical purity : minimum 98%
- Lot/batch No. : 7054 046 172

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source : Kleintierfarm Madoerin AG , 4414 Fuellinsdorf , Switzerland
- Age at study initiation : 15-16 weeks
- Weight at study initiation : 2,6 - 2,7 kg
- Housing : The animals were caged individually in stainless steel cages with automatic drinking water supply and cleaning system
- Diet : rabbit maintenance diet (pelleted standard Kliba 341 , Klingentalmühle AG , 4303 Kaiseraugst , Switzerland) , ad libitum
- Water : tap water , ad libitum
- Acclimation period : 4 days

ENVIRONMENTAL CONDITIONS
- Temperature : 22°C +/- 3°C
- Humidity : 40-70%
- Air changes (per hr) : 10-15
- Photoperiod (hrs dark / hrs light) : 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: The test article was applied moistened with tap water.

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit) : 0.5 g moistened with tap water.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 (2 males , 1 female)

Details on study design:

TEST SITE
- Area of exposure : Application was made to one intact skin site on the clipped dorsum ( 3.0 x 3.0 cm) of each rabbit .
- Type of wrap if used : The test article was applied under a patch of surgical gauze approximately 3.0 x 3.0 cm . When the patch was in place , it was covered with aluminum foil and fastened to the body with an elastic bandage .

REMOVAL OF TEST SUBSTANCE
- Washing (if done) : After the dressing was removed the skin was flushed with luke warm tap water

OBSERVATIONS
- Viability/Mortality : Daily
- Body weights : Day 1 and at termination of test on a Mettler PK 16 balance
- Symptoms : The skin reaction was. assessed at 1, 24, 48 and 72 hours intervals after the removaI of the dressing, gauze patch and test article. The corrosive properties of the test article to and the colour of the treated skin area were described and recorded.

SCORING SYSTEM : The skin reaction was assessed according to the OECD Guidelines for Testing of Chemicals, Section 4, number 404, pp. 3-4.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

other: 1h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

other: 24h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

other: 48h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

other: 72h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

other: 1h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

other: 24h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 7

Irritation parameter:

edema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

other: 48h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

other: 72h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Irritation : Pyridin-2-aldoxim showed a primary irritation score of 0 when applied to intact rabbit skin.
Corrosion : No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.

Other effects:

In the area of application no discoIoration of the skin was observed which could be related to effects of the test article.
The body weight gain of all rabbits was similar.
No acute toxic symptoms were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The study was performed according to the OECD TG404 without deviations and according to the good laboratory practice principles, it is considered to be of the highest quality (reliability Klimisch 1). The criteria of validity of the test system are fulfilled. The test material was considered to be not irritating under the conditions of the test.
The calculated primary irritation index was fond to be : mean irritation index for intact skin : 3.1

Executive summary:

The test substance Pyridin-2-aldoxim was investigated for its potential to cause irritation on the rabbit skin according to OECD TG404. 0.5 g of the substance moistened with tap water was applied to the intact skin of the shaved area. It was covered with a 3.0 cm. x 3.0 cm patch of surgical gauze. The gauze was covered with aluminum foil and then covered with an occlusive dressing. Four hours after the application, the dressing was removed and the skin was flushed with luke warm tap water. The skin reaction was assessed according to the OECD Guidelines for Testing of Chemicals, Section 4, number 404, pp. 3 -4. The skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removaI of the dressing, gauze patch and test article.

Under the conditions of this experiment, Pyridin-2 -aldoxim was found to cause a primary irritation score of 0 when applied to intact rabbit skin.

In the area of application, no discoloration of the skin was observed which could be related to effects of the test article.

No corrosive effect had occurred on the skin at each measuring interval.

According to EEC Council Directive, 83/467/EEC, July 1983 Brussels, Belgium, the mean value (24 -72 hours) of the scores for each type of lesion, calculated for each animal separately, is the following :

Animal No. 43 (male) : Erythema = 0 ; Edema = 0

Animal No. 44 (male) : Erythema = 0 ; Edema = 0

Animal No. 45 (female) : Erythema = 0 ; Edema = 0