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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:
August 24-17, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
T-7145
IUPAC Name:
T-7145
Details on test material:
- Name of test material (as cited in study report:T-7145.6
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: pure substance
- Physical state: Clear, odorless liquid
- Analytical purity: >99.5%
- Expiration date of the lot/batch: 28 April 2000

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charels River Nederland, Someren The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: 3.5 kg
- Housing: Individual housing in cages with perforated floors
- Diet (e.g. ad libitum): Standard diet 100 g per day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days prior to treatmetn
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 C
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 light/12 dark
IN-LIFE DATES: From: 24 Aug. 1999 To 27 Aug. 1999:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: one eye was treated, the other eye served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Observation period (in vivo):
72 hours
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: According to OECD Guidelines
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: See section :Any other information on results incl. tables

Any other information on results incl. tables

REMARK from section OVERALL IRRITATION/ CORROSION RESULTS:

Instillation of 0.1 ml into one eye of each of the three rabbits resulted in iritation of the conjunctivae, which was seen as redness. The irritation had completely resolved within 24 hours in all animals. No iridial irritation or corneal opacity was observed and treatment of the eyes with 2% fluorescein, 24 hours after instillation, revealed no corneal epithelial damage in any of the animals.

ANY OTHER INFORMATION :

 

 

 

Mean 24-72 hours

 

 

 

 

 

Animal

Corneal Opacity

Iris

Conjunctivae

Redness

Conjunctivae

Chemosis

504

0

0

0

0

505

0

0

0

0

507

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:
Not Irritating
Executive summary:

Instillation of 0.1 ml into one eye of each of the three rabbits resulted in irritation of the conjunctivae, which was seen as redness. The irritation had completely resolved within 24 hours in all animals. No iridial irritation or corneal opacity was observed and treatment of the eyes with 2% fluorescein, 24 hours after instillation, revealed no corneal epithelial damage in any of the animals.

Based on these results, T-7145 does not have to be classified and has no obligatory labelling requirement for eye irritation.