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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:
1988-06-23 to 1988-06-27
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test substance not described in sufficient details

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Witamol 110
- Substance type: product
- Physical state: liquid
- Stability under test conditions: no data
- Storage condition of test material: at room temperature in a galss srew-top bottle
- Other: none

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: approx. 12 - 16 weeks
- Weight at study initiation: 2.55 - 3.43 kg
- Housing: single in suspended metal cages
- Diet: Rabbit Diet, Preston Farmers Limited, New Leak, Boston, Lincolnshire, U.K. (ad libitum)
- Water: mains drinking water (ad libitum)
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 18
- Humidity (%): 60 - 75
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 1988-06-23 To: 1988-06-27

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye of each animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
Duration of treatment / exposure:
single administration; unlimited exposure (not rinsed)
Observation period (in vivo):
1, 24, 48 and 72 hours after treatment
Number of animals or in vitro replicates:
6 (4 female, 2 male)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to Draize J. H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"


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 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.56
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.44
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjuntivae (Redness): 0.56
- Conjuntivae (Chemosis): 0.44
- Overall irritation score: 3.9/110
Other effects:
DESCRIPTION OF LESIONS: Iridial inflammation was confined to two treated eyes one hour after treatment. Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment. The conjunctival irritation regressed and all treated eyes appeared normal 48 to 72 hours after treatment.

Any other information on results incl. tables

Table #: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0/0/0/0

 1/0/1/0/0/0

 2/1/2/1/2/2

 1/1/1/1/1/1

24 h

 0/0/0/0/0/0

 0/0/0/0/0/0

1/1/2/1/2/1 

 0/1/2/0/2/1

48 h

 0/0/0/0/0/0

 0/0/0/0/0/0

 0/0/1/0/1/0

 0/0/1/0/1/0

72 h

 0/0/0/0/0/0

 0/0/0/0/0/0

 0/0/0/0/0/0

 0/0/0/0/0/0

Average 24h, 48h, 72h

 0

 0

 0.56

 0.44

Area effected

 

 

Maximum average score (including area affected, max 110)

 

 

 

Reversibility*)

 -

 -

c. 

 c.

Average time (unit) for reversion

 -

 -

 72 hours

 72 hours

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters was only slightly eye irritating.