4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 01, 2002 - May 19, 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

April 24th, 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid

EC Number:

230-907-9

EC Name:

4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid

Cas Number:

7365-45-9

Molecular formula:

C8H18N2O4S

IUPAC Name:

2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: 17 weeks
- Weight at study initiation: 2.65 kg (range from 2.51 to 2.75)
- Housing: kept separately in special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm², a shelter with an integrated sitting board of about 1820 cm²; overall height: 60 cm)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: more than 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 20
- Humidity (%): 42 - 58
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: day 1 To: day 8

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

30 s

Observation period (in vivo):

1 hour after treatment, after 24, 48, and 72 hours, then daily up to day 8 of the experimental part

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Redness of the conjunctivae and discharge were regarded as slight transient signs of mechanical irritation. The test material should not be regarded as an irritant for the eyes.

Executive summary:

The primary eye irritation was assessed in accordance with OECD TG 405. For the test of primary eye irritation, 0.1 g of the test material was applied into the conjunctival sac of rabbits. The study was started as an initial test with 1 animal and followed by the confirmatory test with 2 further animals. 

No signs of irritation could be observed at the cornea or iris. The conjunctivae showed redness (score 1) at the first (1 hour) and second (24 hours) reading. Chemosis (score 1) was seen in the first reading. Furthermore discharge (score 1 and 2) at the first reading was observed. Thereafter no signs of irritation were observed. The untreated eyes were unchanged.

 

	Mean score (24h, 48h, 72h)			Maximum value (24h, 48h or 72h)
Animal No.	34	32	39	34	32	39
Cornea	0.00	0.00	0.00	0	0	0
Iris	0.00	0.00	0.00	0	0	0
Conjunctivae (Redness)	0.33	0.33	0.00	1	1	0
Conjunctivae (Chemosis)	0.00	0.00	0.00	0	0	0

 

Redness of the conjunctivae and discharge were regarded as slight transient signs of mechanical irritation.