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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:
21 July 1997 - 26 July 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in accordance with EPA, OECD, EC, and Japanese test guidelines, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Note - study report refers to the guideline as number 404 "Acute Eye Irritation / corrosion", adopted 24 February 1987.
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF, Requirements for Safety Evaluation of Agricultural Chemicals and Testing Guidelines for Toxicology Studies, Primary Eye Irritation Study, 59 NohSan No 4200, Agricultural Production Bureau, January 28, 1985.
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Benzoflex 2-45 (Diethylene glycol dibenzoate DEGDB)
- Physical state: Clear colourless liquid
- Analytical purity: Diethylene glycol dibenzoate - 89.9% (w/w)
- Impurities (identity and concentrations):
Diethylene glycol monobenzoate - 5.85% (w/w)
Dipropylene glycol dibenzoate - 1.50% (w/w)
Ethylene glycol dibenzoate - 0.19% (w/w)
Triethylene glycol dibenzoate - 0.15% (w/w)
Unidentified component 1 - 0.10% (w/w)
Unidentified component 2 - 0.10% (w/w)
Unidentified component 3 - 0.54% (w/w)
- Lot/batch No.: 56625030
- Expiration date of the lot/batch: 19 May 1998
- 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: Harlan Interfauna UK Ltd., Huntingdon, Cambridgeshire, England
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: 2.4 to 2.9 kg
- Housing: Housed individually in metal cages with perforated floors
- Diet: SDS Stanrab (P) SQC Rabbit Diet, provided ad libitum
- Water: mains drinking water provided ad libitum
- Acclimation period: At least 18 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.5 - 21.5°C
- Humidity (%): 50 - 74%
- Air changes (per hr): 19 per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light per 24 hour period


IN-LIFE DATES: From: 21 July 1997 To: 26 July 1997

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The eye contralateral to the treated eye remained untreated in each animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Not applicable - a single instillation of test substance was made with no subsequent washing.
Observation period (in vivo):
3 days (observations made 1, 24, 48, and 72 hours after instillation).
Number of animals or in vitro replicates:
Six
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: The scoring system used is consistent with that described in OECD test Guideline 405.


TOOL USED TO ASSESS SCORE: handheld light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(Redness)
Basis:
animal: All animals
Time point:
other: 1 hour (24 hours in two animals)
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Basis:
animal: All animals
Time point:
other: All time points
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: All animals
Time point:
other: All timepoints
Score:
0
Max. score:
0
Irritant / corrosive response data:
Transient hyperaemia of blood vessels only was observed in all animals. These reactions had resolved in all instances by one or two days after instillation. No corneal damage or iridial inflammation was observed.
Other effects:
There were no signs of ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Instillation of DEGDB into the eye of the rabbit did not elicit a positive response according to the established test criteria.
Executive summary:

An assessment of the potential of the test material DEGDB to cause eye irritation in rabbits was undertaken. The study was conducted according to EPA, OECD, EC, and Japanese test guidelines, and in compliance with GLP.

The neat test material (0.1 ml) was instilled into one eye of six healthy adult rabbits, and the effects observed for three days (72h).

Transient hyperaemia of blood vessels only was observed in all animals. These reactions had resolved in all instances by one or two days after instillation. No corneal damage or iridial inflammation was observed.

Instillation of DEGDB into the rabbit eye did not elicit a positive response according to the established test criteria.

DEGDB is not irritant to the eye.