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Diss Factsheets

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:
25 Mar - 08 Apr 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2012
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
Aug 1998
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Food and Argricultural Materials Inspection Centre (FAMIC), 12 Nohsan, Notification No. 8147, April 2011; including the most recent partial revisions
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Health Care Inspectorate, Ministry of Health, Welfare and Sport, Den Haag, The Netherlands

Test material

Constituent 1
Chemical structure
Reference substance name:
{1,4-diazabicyclo[2.2.2]octan-2-yl}methanol
EC Number:
692-731-2
Cas Number:
76950-43-1
Molecular formula:
C7H14N2O
IUPAC Name:
{1,4-diazabicyclo[2.2.2]octan-2-yl}methanol
Details on test material:
- Name of test material (as cited in study report): [trade name]
- Substance type: off-white powder with lumps
- Analytical purity: 90.7% (subsequent information by sponsor)
- Impurities (identity and concentrations): 1,5-diazabicyclo[3.2.2]nonane-3-ol 8.9% (subsequent information by sponsor)
- Expiration date of the lot/batch: 20 Dec 2014
- Storage condition of test material: at room temperature in the dark
- Other: pH: 11.0 at concentration of 10%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River France, L'Arbresle, France
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.59 kg - 2.92 kg
- Housing: individually in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters
- Diet: pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad, Italy) approx. 100 g per day; hay and wooden sticks were available
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 Mar 2014 To: 08 Apr 2014

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- the test material was ground to a powder
- Amount applied: 31.9 mg (range 31.8 - 32.1 mg) (equivalent to a volume of approx. 0.1 mL)


Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
7 days
Reading time points: 1, 24, 48 and 72 h and 7 days
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: solution of 2% fluorescein in water

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
There was no evidence of ocular corrosion. Instillation of the test substance into one eye of each of three rabbits resulted in effects on the iris and conjunctivae. Iridial irritation grade 1 was observed in two animals and resolved within 24 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 7 days in all animals.
No corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.
Other effects:
No staining of (peri) ocular tissues by the test substance was observed and no test substance remnants were seen.

Any other information on results incl. tables

Table 1. Results of eye irritation study

Rabbit #

Time [h]

conjunctivae

iris

cornea

redness

swelling

1

1

2

2

0

0

24

2

1

0

0

48

2

0

0

0

72

1

0

0

0

7d

0

0

0

0

average
24+48+72

1,7

0,3

0,0

0,0

2

1

2

2

1

0

24

2

1

0

0

48

2

1

0

0

72

1

0

0

0

7d

0

0

0

0

average
24+48+72

1,7

0,7

0,0

0,0

3

1

2

2

1

0

24

2

1

0

0

48

2

0

0

0

72

1

0

0

0

7d

0

0

0

0

average
24+48+72

1,7

0,3

0,0

0,0

 

 

Time [h]

conjunctivae 

iris

 

cornea

 

 

redness

swelling

average
score

1

2,00

2,00

0,67

0,00

24

2,00

1,00

0,00

0,00

48

2,00

0,33

0,00

0,00

72

1,00

0,00

0,00

0,00

7d

0,00

0,00

0,00

0,00

24+48+72

1,67

0,44

0,00

0,00

No mortality occurred and no signs of systemic toxicity were observed in the animals during the test period.

Applicant's summary and conclusion

Interpretation of results:
other:
Remarks:
CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified
DSD: not classified