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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:
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-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 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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

Resultsopen allclose all
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
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
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
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
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).