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:
29 Dec 1987 - 01 Jan 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (purity of test substance not specified).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 12. May 1981
Deviations:
yes
Remarks:
purity of test substance not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): T-4113
- Physical state: white powder
- Analytical purity: no data
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, PA, USA
- Age at study initiation: young adult
- Weight at study initiation: 2320 to 2501 g
- Housing: individually in screen-bottom stainless stell cages (heavy gauge)
- Diet: measured amount of Purina High Fiber Rabbit Chow
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 39 - 41
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 29 Dec 1987 To: 01 Jan 1988

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.04 g (equivalent to 0.1 mL)
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
72 hours
reading time points: 1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3 (1 male and 2 females)
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

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 hours
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 hours
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 hours
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Slight conjunctival redness and chemosis (Grade 1) was observed at 1 hour for all animals but was completely reversed in two animals within 24 hours and in the third animal within 48 hours.
Other effects:
No pain response was elicited from any animal following instillation of the test material. Blanching of the conjunctivae was observed in one animal at 1 hours.

Any other information on results incl. tables

Table1: Individual Eye Irritation Scores

Cornea

Iritis

Conjunctivae Score

Score

Score

Redness

Chemosis

Animal 1

1 hour

0

0

2

1

24 hour

0

0

1

1

48 hour

0

0

0

0

72 hour

0

0

0

0

Mean scores (24-72 h)

0

0

0,33

0,33

Animal 2

1 hour

0

0

1

1

24 hour

0

0

0

0

48 hour

0

0

0

0

72 hour

0

0

0

0

Mean Scores (24-72 h)

0

0

0

0

Animal 3

1 hour

0

0

1

1

24 hour

0

0

0

0

48 hour

0

0

0

0

72 hour

0

0

0

0

Mean scores (24-72 h)

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:
DSD: not classified
CLP: not classified