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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo study performed
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 July 1997 - 26 July 1997
Reliability:
1 (reliable without restriction)

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
Details on test material:
- Name of test material (as cited in study report): Benzoflex 9-88 (Dipropylene glycol dibenzoate DPGDB)
- Physical state: Clear colourless liquid
- Analytical purity: Dipropylene glycol dibenzoate - 89.4% (w/w)
- Impurities (identity and concentrations):
Dipropylene glycol monobenzoate - 4.98% (w/w)
Propylene glycol dibenzoate - 2.29% (w/w)
Propylene glycol monobenzoate - 0.28% (w/w)
Propenyloxy propyl benzoate - 2.35% (w/w)
- Lot/batch No.: 56635211
- Expiration date of the lot/batch :September 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 13 weeks.
- Weight at study initiation: 2.3 to 3.0 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: 18 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.5 to 21.5°C
- Humidity (%): 50 to 74%
- Air changes (per hr): 19 hours
- Photoperiod: 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: Mean scores (24, 48 and 72 hours)
Score:
0.11
Max. score:
0.33
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
animal: all animals
Time point:
other: Mean scores (24, 48 and 72 hours)
Score:
0.11
Max. score:
0.33
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 time points
Score:
0
Max. score:
0
Irritant / corrosive response data:
Instillation of DPGDB into the rabbit eye did not elicit a positive response according to the established test criteria.
A single instillation of DPGDB into the eye of the rabbit elicited transient very slight conjunctival irritation.
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 DPGDB into the eye of the rabbit did not elicit a positive response according to the established test criteria.
A single instillation of DPGDB into the eye of the rabbit elicited transient very slight conjunctival irritation.
Executive summary:

A study was performed to assess the eye irritation potential of DPGDB to the rabbit. The study was conducted in accordance with OECD, EC, US EPA and Japanese test guidelines, and in compliance with GLP.

Approximately 0.1 mL of the test substance was instilled into one eye of 6 rabbits, and the effects observed for 72 hours. The eyes were not rinsed after instillation of the test material.

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.

There were no signs of toxicity or ill health in any of the rabbits during the observation period.

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

DPGDB is not irritant to the eye.