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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
Study period:
02 June 1986 - 05 June 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD guidelines and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Chemical name: Neodecane peroxoic acid 1,1,3,3-tetramethyl butyl ester
- Appearance: Colouless clear liquid
- CAS-reg. no.: 51240-95-0

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: approximately 10 weeks old
- Weight at study initiation: 2111, 2003 and 2407 grams
- Housing: indiVidually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): ad libitum, standard laboratory animal diet (100 g per day), obtained from Hope Farms, Woerden (LK-01, pellet diameter 4 mm).
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-21.5
- Humidity (%): 55-75
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 02 June 1986 - 05 June 1986

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): as such
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
The eyes are examined 1, 24, 48, and 72 hours after instillation of the test substance. After recordi ng the observations at 24 hours, the eyes of the rabbi ts may be further examined with the aid of fluorescein stain. The untreated eye is used as reference. Another observations, generally performed on day 7, 14 and/or 21, may be needed in order to sufficiently evaluate reversibility or irreversibility.
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM:
Scoring system eye irritation

Cornea: degree of density (area most dense taken for reading)
0 No ulceration or opacity
1 Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 Easily discernible translucent areas, details of iris slightly obscured
3 Nacrous areas, no details of iris visible, size of pupil barely discernible
4 Opaque cornea, iris not discernible through the opacity

Iris
0 Normal
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 No reaction to light, haemorrhage, gross destruction (any or all of these)

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae cornea and iris)
0 Blood vessels normal
1 Some blood vessels definitely hyperaemic
(injected)
2 Diffuse, crimson colour, individual vessels not easily discernible
3 Diffuse, beefy red

Chemosis (lids and/or nictitating membranes)
0 No swelling 0
1 Any swelling above normal (includes nictitating membranes)
2 Obvious swelling with partial eversion of lids
3 Swelling with lids about half-closed
4 Swelling with lids more than half-closed

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
1 animal
Time point:
other: 24-48-72
Score:
0.67
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: all other scores were 0 for 24-48-72 hours, see table below.
Irritant / corrosive response data:
One hour after dosing slight conjunctival redness and chemosis were observed in all animals; in two of them these effects disappeared wi thi n the next twenty-four hours, whereas in the third animal slight conjunctival hyperaemia was observed for forty-eight hours. Adverse effects on the cornea and the iris were not obse rved in any of the rabbits during the entire observation period. Treatment of the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any epithelial damage. Signs of systemic intoxication were not observed.

Any other information on results incl. tables

Rabbit No and sex

Region of the eye

Hours after instillation

Average 24-48-72 hours

1

24

48

72

4-7-14(days)

 

1-f

Cornea

Degree of opacity

0

0

0

0

0

0

 

Iris

0

0

0

0

0

0

 

Conjunctivae

Redness

1

0

0

0

0

0

 

 

Chemosis

1

0

0

0

0

0

2-f

Cornea

Degree of opacity

0

0

0

0

0

0

 

Iris

 

0

0

0

0

0

0

 

Conjunctivae

Redness

1

0

0

0

0

0

 

 

Chemosis

1

0

0

0

0

0

3-f

Cornea

Degree of opacity

0

0

0

0

0

0

 

Iris

 

0

0

0

0

0

0

 

Conjunctivae

Redness

1

1

1

0

0

0.67

 

 

Chemosis

1

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
One hour after dosing slight conjunctival redness and chemosis were observed in all animals; in two of them these effects disappeared wi thi n the next twenty-four hours, whereas in the third animal slight conjunctival hyperaemia was observed for forty-eight hours (mean score 24-48-72 hours is 0.67). Therefore the substance is not classified as eye irritant.
Executive summary:

The substance was tested, in the rabbit acute eye irritation/corrosion test to determine its possible irritating or corrosive effects. Instillation of 0.1 ml of the test substance in one of the eyes of three female rabbits resulted in slight redness and swelling of the conjunctivae. In two of the animals the conjunctival effects disappeared within twenty-four hours, whereas in one animal sl ight redness persi sted for forty-eight hours. No adverse effects on the cornea and the iris were observed in any of the rabbits during the entire observation period.