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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
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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