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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Draize test, comparable to guideline, with acceptable restrictions (24-h exposure, observations at 25 and 48 h only, occlusive dressing).
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24-h exposure, observations at 25 and 48 h only, occlusive dressing
Principles of method if other than guideline:
Draize test: Local tolerance test in rabbit, evaluation of the index of primary cutaneous irritation on shaved, intact or abraded skin.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): cis-pentene-2 nitrile commercial
- Physical state: clear liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 2.5 to 3.5 kg
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
No data


IN-LIFE DATES: From 1981-03-26 to 1981-03-29

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved, intact or abraded areas on each animals
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin areas of the test animal served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
3 days. Examinations were made at 25 and 72 hours.
Number of animals:
4 animals
Details on study design:
TEST SITE
- Area of exposure: diameter of 3 cm
- % coverage: no data
- Type of wrap if used: gauze + aluminium disk + adhesive tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: according to Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
intact skin
Time point:
other: overall 25-72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
intact skin
Time point:
other: overall 25-72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
abraded skin
Time point:
other: overall 24-72 h
Score:
0.38
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
abraded skin
Time point:
other: overall 25-72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
On the treated intact skin, no effect was observed. Mean score was 0.0 for erythema and edema.
On the treated abraded skin, very slight erythema was observed and reversed within 72 hours. Mean score was 0.4 for erythema and 0.0 for edema.
Other effects:
No effect

Any other information on results incl. tables

Table 7.3.1/1: Mean irritant/corrosive response data for animals with intact skin at each observation time up to removal of animals from the test

Score at time point / Reversibility

Erythema

Max. score 4

Edema

Max. score 4

25 h

0.00

0.00

72 h

0.00

0.00

Average 25h, 72h

0.00

0.00

Reversibility*)

-

-

Average time (unit) for reversion

-

-

 

 

Table 7.3.1/2: Mean irritant/corrosive response data for animals with abraded skin at each observation time up to removal of animals from the test

Score at time point / Reversibility

Erythema

Max. score 4

Edema

Max. score 4

25 h

0.75

0.00

72 h

0.00

0.00

Average 25h, 72h

0.375

0.00

Reversibility*)

c.

-

Average time (unit) for reversion

72 hours

-

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the condition of this test, 2-pentenenitrile commercial is not classified as skin irritant according to the Directive 67/548/EC and the CLP Regulation (1278/2008).
Executive summary:

In a dermal irritation study performed similarly to the OECD test guideline No. 404, 4 New Zealand White rabbits were exposed to 0.5 mL of undiluted Cis-pentene-2 nitrile commercial. Skin was shaved before application; on each animal one area was intact whereas the other was abraded. Test sites were covered with an occlusive dressing for 24 hours and weren’t washed after this period. Changes were observed at 25 and 72 hours. Irritation was scored by the method of Draize.

 

On the treated intact skin, no effect was observed. Mean score was 0.0 for erythema and edema.

 

On the treated abraded skin, very slight erythema was observed and reversed within 72 hours.

Mean score was 0.4 for erythema and 0.0 for edema.

 

Under the condition of this test, 2-pentenenitrile commercial is not classified as skin irritant according to the Directive 67/548/EC and the CLP Regulation (1278/2008).