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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Even if no guideline is mentioned and the GLP are not stated, the study is similar to the recognised test guideline and is sufficiently described for the assessment.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pent-3-enenitrile
EC Number:
225-060-7
EC Name:
Pent-3-enenitrile
Cas Number:
4635-87-4
Molecular formula:
C5H7N
IUPAC Name:
(3E)-pent-3-enenitrile
Details on test material:
- Name of test material (as cited in study report): trans-pentène-3 nitrile
- Physical state: pale yellow liquid

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: 2.0-3.0 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: 1981-04-01 To: 1981-04-08

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 1h, 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 and Calandra (1962)


TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: overall 24-48-72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: overall 24-48-72 h
Score:
0.08
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: overall 24-48-72 h
Score:
0.25
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: overall 24-48-72 h
Score:
0.42
Max. score:
4
Reversibility:
fully reversible within: 96 h
Irritation parameter:
other: discharge
Basis:
mean
Time point:
other: overall 24-48-72 h
Score:
0
Max. score:
3
Other effects:
No other 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 h

0.00

0.25

0.25

1.00

0.00

1 day

0.00

0.25

0.50

0.75

0.00

2 day

0.00

0.00

0.25

0.25

0.00

3 day

0.00

0.00

0.00

0.25

0.00

4 day

0.00

0.00

0.00

0.00

0.00

7 day

0.00

0.00

0.00

0.00

0.00

Average 24h, 48h, 72h

0.00

0.08

0.25

0.42

0.00

Reversibility*)

-

c.

c.

c.

-

Average time (unit) for reversion

-

48 h

72 h

96 h

-

 *) Reversibility: c. = completely 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, trans-pentene-3-nitrile is not classified as irritating to eyes according to the EU legislation (Directive 67/548/EEC and Regulation 1272/2008/EC).
Executive summary:

In an eye irritation study, 0.1 mL of undiluted trans-pentene-3-nitrile (purity unknown) was instilled into the conjunctival sac of left eye of 4 New Zealand White rabbits. The eyes of the animals weren’t rinsed. The right eye of each rabbit served as control. Eyes were observed at 1h, 1, 2, 3, 4 and 7 days after instillation and grading according to Draize scale.

 

Trans-pentene-3-nitrile produced chemosis (mean score 0.42), conjunctival redness (mean score 0.25), iris lesions (mean score 0.08). Effects were completely reversed after 2 to 4 days.

 

Under the test conditions, trans-pentene-3-nitrile is not classified as irritating to eyes according to the EU legislation (Directive 67/548/EEC and Regulation 1272/2008/EC).