Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 11 April, 2013 to 19 April, 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the OECD Guideline and EU Method in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C12-14 alkylmorpholine
- Analytical purity: 98.3%:
- Lot/batch No.: S-001312
- Expiration date of the lot/batch: 05 December 2017
- Storage condition of test material: Room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand White (Hsdlf:NZW)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12 to 20 weeks old.
- Weight at study initiation: 2.49 or 2.83 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: 2930C Teklad global rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon UK (ad libitum)
- Water: Free access to mains drinking water
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23 °C
- Humidity: 30 to 70%
- Air changes: 15 changes/h
- Photoperiod: The lighting was controlled by a time switch to give 12 h continuous light (06:00 to 18:00) and 12 h darkness

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test substance, and then released.
Observation period (in vivo):
Assessment of ocular damage/irritation was made approx 1 h and 24, 48 and 72 h following treatment.
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize score

TOOL USED TO ASSESS SCORE: Light source from a standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No adverse effects were observed.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: No adverse effects were observed.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in the other treated eye one and 24 h after treatment. Minimal conjunctival irritation was noted in both treated eyes at the 48 h observation. Both treated eyes appeared normal at the 72 h observation.
Other effects:
Both animals showed expected gain in body weight during the study.

Any other information on results incl. tables

Table 1. individual scores and individual total scores for ocular irritation:

Rabbit number and sex

73111 Male

73124 Male

 

IPR = 2

IPR = 2

 

Time after treatment

1 h

 

24 h

48 h

 

72 h

 

1 h

 

24 h

 

48 h

 

72 h

 

Cornea

E = Degree of Opacity

0

0

0

0

0

0

0

0

F = Area of Cornea Involved

0

0

0

0

0

0

0

0

Score (E x F) x 5

0

0

0

0

0

0

0

0

Iris

Score (D x 5)

0

0

0

0

0

0

0

0

Conjunctivae

A = Redness

2

 

1

1

0

2

2

1

0

B = Chemosis

 

1

 

1

1

0

2

1

1

0

C = Discharge

0

 

1

0

0

1

1

0

0

Score (A + B + C) x 2

6

 

6

4

0

10

8

4

0

Total Score

6

 

6

4

0

10

8

4

0

 

Table 2. Individual total scores and group mean scores for ocular irritation:

Rabbit number

and sex

Individual total scores at:

1 h

24 h

48 h

72 h

73111 Male

6

6

4

0

73124 Male

10

8

4

0

Group total

16

14

8

0

Group mean score

8

7

4

0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the study conditions, the test substance produced mild irritation which was fully reversible with 72 h after treatment.
Executive summary:

The study was performed to assess the irritancy potential of C12-14 alkylmorpholine to the eye of the New Zealand White rabbit in accordance with the OECD Guideline 405 and EU Method B.5 in compliance with GLP.

A volume of 0.1 mL of the test substance was placed into the conjunctival sac of the right eye. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test substance, and then released. The left eye remained untreated and was used for control purposes. Theassessment of ocular damage/irritation was made approx 1 h and 24, 48 and 72 h following treatment.

No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in the other treated eye one and 24 h after treatment. Minimal conjunctival irritation was noted in both treated eyes at the 48 h observation. Both treated eyes appeared normal at the 72 h observation. Both animals showed expected gain in body weight during the study. The maximum group mean score was calculated to be 8.0.

Under the study conditions, the test substance produced mild irritation which was fully reversible with 72 h after treatment.