2-methyl-3-butenenitrile

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 OECD 405 (Draize method) with minor deviation (no details on test animals, housing and feeding). The purity is not indicated.

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:

: minor deviation (no details on test animals, housing and feeding)

Principles of method if other than guideline:

Draize test

GLP compliance:

not specified

Remarks:

But the study was performed before GLP statement.

Test material

Test material information

Constituent 1

Reference substance name:

2-methyl-3-butenenitrile

EC Number:

240-596-1

EC Name:

2-methyl-3-butenenitrile

Cas Number:

16529-56-9

Molecular formula:

C5H7N

IUPAC Name:

2-methylbut-3-enenitrile

Details on test material:

- Name of test material (as cited in study report): 2-methyl-3-butenenitrile
- Substance type: no data
- Physical state: light yellow liquid
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: no data

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Source: no data
- Age at study initiation: no data
- Weight at study initiation: From 2.0 kg 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
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g (or mL)
- Concentration (if solution): no data

Duration of treatment / exposure:

Eyes were not rinsed.

Observation period (in vivo):

7 days. Changes were observed at 1, 24, 48, 72, 96 and 168 hours.

Number of animals or in vitro replicates:

4 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE: no


SCORING SYSTEM: Draize scale


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: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.5

Max. score:

3

Reversibility:

fully reversible within: 96 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 96 hours

Results 5

Irritation parameter:

other: Discharge

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Results 6

Irritation parameter:

other: acute irritation score

Basis:

mean

Time point:

other: 1 hour

Score:

9.75

Irritant / corrosive response data:

2-methyl-3-butenenitrile produced chemosis (mean score 0.5), conjunctival redness (mean score 0.5), and Iridial lesions (mean score 0.33) which were completely reversed after 4 days.

Other effects:

No other effect

Any other information on results incl. tables

Table 7.3.2/1: Occular irritation test with 2M3BN

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
60 min	0.00	1.00	2.00	2.00	2.00
24 h	0.00	1.00	1.00	1.00	0.00
48 h	0.00	0.00	0.5	0.25	0.00
72 h	0.00	0.00	0.00	0.25	0.00
96 h	0.00	0.00	0.00	0.00	0.00
168 h	0.00	0.00	0.00	0.00	0.00
Average 24h, 48h, 72h	0.0	0.33	0.5	0.5	0.00
Reversibility*)	-	c.	c.	c.	-
Average time (unit) for reversion		48 h	96 h	96 h	-

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

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under these test conditions, 2-methyl-3-butenenitrile is slightly irritating. However, no classification is required according to EU criteria.

Executive summary:

In an eye irritation study performed similarly to the OECD test guideline No. 405, 0.1 mL of undiluted 2 -methyl-3 -butenenitrile (2M3BN) was instilled into the conjunctival sac of left eye of 4 New Zealand White rabbits. The eyes of the animals were not rinsed after instillation. The right eye of each rabbit served as control. Changes were observed at 1, 24, 48, 72, 96 and 168 hours after dosing and grading according to Draize scale.

 

2M3BN produced chemosis (mean score 0.5),conjunctival redness (mean score 0.5), and iridial lesions (mean scores 0.33). All these effects were completely reversed after 4 days. No corneal lesions (mean score 0.0) were observed.

Under the test conditions, 2M3BN is slightly irritating to eyes but no classification is required according to the EU legislation (Directive 67/548/EEC and Regulation 1272/2008/EC).