(Z)-pent-2-enenitrile

Eye irritation

Administrative data

Endpoint:

eye 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: Study comparable to guideline with minor deviation (no details on test animals, housing and feeding).

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

no details on test animals and housing/feeding conditions.

Principles of method if other than guideline:

Draize test: Local tolerance test in rabbit, evaluation of the index of ocular irritation.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

(Z)-pent-2-enenitrile

EC Number:

247-323-5

EC Name:

(Z)-pent-2-enenitrile

Cas Number:

25899-50-7

Molecular formula:

C5H7N

IUPAC Name:

(2Z)-pent-2-enenitrile

Constituent 2

Reference substance name:

pent2-enenitrile

IUPAC Name:

pent2-enenitrile

Details on test material:

- Name of test material (as cited in study report): cis-pentène-2 nitrile commercial
- Physical state: clear liquid
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 2.0 to 3.0 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 1981-03-24 to 1981-03-31

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: right eye of each animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

Eyes remained unwashed

Observation period (in vivo):

7 days. Eyes were examined at 1 hour, 1, 2, 3, 4 and 7 days after instillation.

Number of animals or in vitro replicates:

4 animals

Details on study design:

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


SCORING SYSTEM: according to Draize (1959) and Kay & Calandra (1962)


TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: overall 24-48-72 h

Score:

0.25

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: overall 24-48-72 h

Score:

0.58

Max. score:

2

Reversibility:

not fully reversible within: 7 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: overall 24-48-72 h

Score:

0.17

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: overall 24-48-72 h

Score:

0.25

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

other: discharge

Basis:

mean

Time point:

other: overall 24-48-72 h

Score:

0

Max. score:

3

Irritant / corrosive response data:

2-Pentenenitrile produced slight chemosis (mean score 0.25), slight conjunctival redness (mean score 0.2), and slight corneal lesions (mean score 0.25) which were completely reversed after 2 days. Slight iris lesions (mean score 0.6) were not completely reversed after 7 days.

Other effects:

No effect.

Any other information on results incl. tables

Table 7.3.2/1: Mean Irritant/corrosive response data for all animals at each observation time up to removal from the test 

Score at time point / Reversibility	Cornea Max. score: 4	Iris Max. score: 2	Conjunctivae Max. score: 3	Chemosis Max. score: 4	Discharge Max. score: 3
1 hour	0.75	1.00	1.75	1.75	1.75
1 day	0.75	1.00	0.50	0.75	0.00
2 days	0.00	0.50	0.00	0.00	0.00
3 days	0.00	0.25	0.00	0.00	0.00
4 days	0.00	0.25	0.00	0.00	0.00
7 days	0.00	0.25	0.00	0.00	0.00
Average 24h, 48h, 72h	0.25	0.58	0.17	0.25	0.00
Reversibility*)	c.	n.c.	c.	c.	-
Average time (unit) for reversion	48 h	-	48 h	48 h	-

*) 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 test conditions, cis-2-Pentenenitrile commercial is not classified as irritating to eyes according to the Directive 67/548/EEC and the CLP Regulation (1272/2008).

Executive summary:

In an eye irritation study performed similarly to the OECD test guideline No. 405, 0.1 mL of undiluted cis-2-Pentenenitrile commercial was instilled into the conjunctival sac of left eye of 4 New Zealand White rabbits. The eyes of the animals were not washed after instillation. The right eye of each rabbit served as control. Eyes were examined at 1 hour, 1, 2, 3, 4 and 7 days after instillation and grading according to Draize scale.

 

Cis-2-Pentenenitrile produced slight chemosis (mean score 0.25), slight conjunctival redness (mean score 0.2), and corneal lesions (mean score 0.25) which were completely reversed after 2 days. Slight iris lesions (mean score 0.6) were not completely reversed after 7 days.

 

Under the test conditions, cis-2-Pentenenitrile commercial is slighlty irritating to eyes and is not classified as irritating to eyes according to the Directive 67/548/EEC and the CLP Regulation (1272/2008).