N-(4-chlorobenzhydryl)piperazine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journals and saffety assesment reports

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

European Union Risk Assessment Report : Piperazine

Author:

European Chemicals Bureau

Year:

2005

Bibliographic source:

European Union Risk Assessment Report : Piperazine, 3rd Priority List Volume: 56;Final Report, 2005

Reference 2

Reference Type:

publication

Title:

Chemical burns of the rabbit cornea.

Author:

Carpenter, C.P., Smyth, H.F.

Year:

1946

Bibliographic source:

American Journal of Ophthalmology, 29, 1363–1372, 1946

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Eye irritation test of piperazine was conducted on rabbits.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Piperazine

EC Number:

203-808-3

EC Name:

Piperazine

Cas Number:

110-85-0

Molecular formula:

C4H10N2

IUPAC Name:

Piperazine

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report):piperazine
- Molecular formula :C4H10N2
- Molecular weight:86.136 g/mol
- Substance type:Organic
- Physical State: Solid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Piperazine
- Molecular formula : C4H10N2
- Molecular weight : 86.137 g/mole
- Substance type:Organic
- Physical state: Solid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

other: sulphuric acid and ammonium hydroxide

Controls:

not specified

Amount / concentration applied:

0.005 ml of a 5% solution was applied

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

24 hours

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

5

Details on study design:

Normal rabbit eyes were selected on basis of visual inspection after staining with a 5% aqueous solution of fluorescein,and flushed out with distilled water 20 seconds after application. After a 2-hour resting period, 0.005 ml of a 5% solution was applied to the centre of the cornea while the lids were retracted. About one minute later the lids were released, and 18-24 hours later the eyes were stained with fluorescein and the injury scored
Eighteen to 24 hours later, the eye is examined in strong diffuse daylight, then stained with fluorescein, and the injury scored.

Scoring System:Injury grade Definition
1 0.5 ml. undiluted gives injury of 0 to 1.0 points
2 0.5 ml. undiluted gives injury of over 1.0 up to 5.0 points
3 0.1 ml. undiluted gives injury of up to 5.0 points (0.5 ml. gives over 5.0)
4 0.02 ml. undiluted gives injury of up to 5.0 points (0.1 ml. gives over 5.0)
5 0.005 ml. undiluted gives injury of up to 5.0 points (0.02 ml. gives over 5.0)
6 Excess of 40% solution gives injury of up to 5.0 points (0.005 ml. gives over 5.0)
7 Excess of 15% solution gives injury of up to 5.0 points (40% gives over 5.0)
8 Excess of 5% solution gives injury of up to 5.0 points (15% gives over 5.0)
9 Excess of 1% solution gives injury of up to 5.0 points (5% gives over 5.0)
10 Excess of 1% solution gives injury of over 5.0 points

Results and discussion

In vivo

Results

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

9

Max. score:

10

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Piperazine caused etching and necrosis of the rabbit cornea
Together with sulphuric acid and ammonium hydroxide, piperazine was given the grade 9 on a scale ranging from 1 to 10, with necrosis covering 60-90% of the cornea.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

An aqueous solution containing 1-5% piperazine (assumingly piperazine base) caused etching and necrosis of the rabbit cornea.
Hence piperazine was considered to be corrosive to rabbit eyes.

Executive summary:

An ocular irritation study was performed on rabbits to assess the irritation potency of the test chemical, piperazine.

Normal rabbit eyes were selected on basis of visual inspection after staining with a 5% aqueous solution of fluorescein, and flushed out with distilled water 20 seconds after application. After a 2-hour resting period, 0.005 ml of a 5% solution was applied to the centre of the cornea while the lids were retracted. About one minute later the lids were released, and 18-24 hours later the eyes were stained with fluorescein and the injury scored.

Together with sulphuric acid and ammonium hydroxide, piperazine was given the grade 9 on a scale ranging from 1 to 10, with necrosis covering 60-90% of the cornea. An aqueous solution containing 1-5% piperazine (assumingly piperazine base) caused etching and necrosis of the rabbit cornea.

Hence piperazine was considered to be corrosive to rabbit eyes.