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EC number: 907-434-8 | CAS number: -
Eye irritation
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:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- 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
- 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 substance name:
- Benzoflex 2-45
- IUPAC Name:
- Benzoflex 2-45
- Reference substance name:
- Oxydiethylene dibenzoate
- EC Number:
- 204-407-6
- EC Name:
- Oxydiethylene dibenzoate
- Cas Number:
- 120-55-8
- Molecular formula:
- C18H18O5
- IUPAC Name:
- 2-[2-(benzoyloxy)ethoxy]ethyl benzoate
- 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
- Storage condition of test material: Room temperature.
Constituent 1
Constituent 2
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:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: All animals
- Remarks:
- all animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: All animals
- Remarks:
- average score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- All animals
- Basis:
- animal:
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal:
- Time point:
- 72 h
- Score:
- 0 - 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: all animals
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0 - 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- 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:
- other:
- Remarks:
- EU-GHS criteria not met
- 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.
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