N-2-hydroxyethyllactamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The study was conducted similar to a appropriate OECD test guideline and in compliance with GLP. Only limited information on the test material is available. No analytical purity of the test substance is given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2 Oct 2012

Deviations:

yes

Remarks:

Relative humidity/temperature exceeded guideline specific standard values. Occular observations were only performed for 3 days.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-2-hydroxyethyllactamide

EC Number:

226-546-1

EC Name:

N-2-hydroxyethyllactamide

Cas Number:

5422-34-4

Molecular formula:

C5H11NO3

IUPAC Name:

N-2-hydroxyethyllactamide

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: in grid-bottomed metal cages
- Diet: antibiotic-free pelleted rabbit diet, ad libitum
- Water: drinking water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 14 - 22
- Humidity (%): 71 - 90
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

3 days
Reading time points: 24, 48 and 72 h

Number of animals or in vitro replicates:

6 females

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: binocular loupe / slit lamp / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0.22

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Instillation of 0.1 mL of N-2-hydroxyethyllactamide into one eye of each of six rabbits resulted in effects of slight conjunctival redness (grade 1) 24 hours post-application of the test material. This response was maintained by one animal 48 h post-application but had disappeared within 72 h. The average conjunctivae score was calculated to be 0.22. No eye irritating effects were recorded for corneal opacity, iridial effects and chemosis. Therefore, the mean values were 0.0. No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table 1: Individual eye irritation values

Rabbit no.	Time [h]	Conjunctivae Redness               Swelling		Iris	Cornea
1	24 48 72 average	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0
2	24 48 72 average	1 0 0 0.33	0 0 0 0	0 0 0 0	0 0 0 0
3	24 48 72 average	1 0 0 0.33	0 0 0 0	0 0 0 0	0 0 0 0
4	24 48 72 average	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0
5	24 48 72 average	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0
6	24 48 72 average	1 1 0 0.67	0 0 0 0	0 0 0 0	0 0 0 0

Table 2: Mean eye irritation values

Time [h]	Conjunctivae Redness               Swelling		Iris	Cornea
24 48 72 average	0.5 0.17 0 0.22	0 0 0 0	0 0 0 0	0 0 0 0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

CLP: not classified