Valeronitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: the study was performed according to OECD-/EU-testing guidelines, but not under GLP; therefore the study was considered to have Klimisch 2

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Dir. 79/831/EEC, Annex V

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Valeronitrile

EC Number:

203-781-8

EC Name:

Valeronitrile

Cas Number:

110-59-8

Molecular formula:

C5H9N

IUPAC Name:

pentanenitrile

Details on test material:

- Physical state: Colourless liquid
- Density: 0.804
- Quantity of test sample: ca. 200 g
- Date of receipt: 7 February 1983
- pH-value: 9.6 (measured during test)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: several accredited breeders
- Weight at study initiation: ca. 2.5 kg (+/- 200 g)
- Housing: individual housing on polystyrene cages with perforated polystyrene floor
- Diet (e.g. ad libitum): 150 g per rabbit & day of complete maintenance food (granulés Lapin Entretien "112" UAR, 91360 Villemoisson, Orge)
- Water (e.g. ad libitum): softened and filtered tap water
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C (+/- 3°C)
- Humidity (%): 30-70%
- Air changes (per hr): 12 times per hour (pre-filtered air 15 µm)
- Photoperiod (hrs dark / hrs light): artificial light for 12 hours

Test system

Type of coverage:

semiocclusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml as such.

Duration of treatment / exposure:

4 hours

Observation period:

Observation 1 hour, 24 hours, 48 hours and 72 hours after removal of patch.

Number of animals:

6 animals

Details on study design:

The day before application, the rabiits were carefully clipped on the back and flanks with a fine toothed electric clipper to bare a surface of 14 x 14 cm. 0.5 ml of test substance as such was applied on a Codex hydrophylic sight layer gauze pad of ca. 2.5 cm², previously laid down on the skin to avoid any loss of test substance.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24h

Score:

0.5

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 48h

Score:

0.5

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 72h

Score:

0.33

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 48h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 72h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Slight erythema (score 1) were noted in 4 out of 6 animals one hour up to 72 hours after removal of the patch. No oedema were observed. Reversibility was not mentioned in the report.

Other effects:

No other findings reported.

Any other information on results incl. tables

The results of PII were summarized below:

Observation	Mean values over 24, 48 & 72 hours (PII)						Mean value
	No.1	No.2	No.3	No.4	No.5	No.6
Erythema	0.66	0.33	0	0	0.66	1	0.43
Oedema	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was classified as non-irritant to skin.

Executive summary:

The study was performed in 1983, following the EU-testing guideline B.4 as non-GLP-study. 6 New Zealand White rabbits were used in this study. 0.5 ml test item was applied undiluted on intact and clipped skin area on the back and flanks by semi-occlusive dressing. Only very slight erythema (score 1) was noted in 4 ot of 6 animals after removal of the patch. No oedema were observed.

Based on these results Valeronitrile was not classified for skin irritation.