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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:
02JUL1992 - 09JUL1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1987), referenced as Method B5 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
date of inspection: 17MAR1992

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): PEMP (2,2-Dimethylpropanetatryl tetrakis (3-mercaptopropionate))
- Substance type: Organic
- Physical state: Pale yellow clear liquid with sulfur odor
- Storage condition of test material: Room temperature under nitrogen, shielded from light
- No information on purity
Specific details on test material used for the study:
The test was performed with PEMP product, the registered substance.

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, United Kingdom
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.90 - 3.48 kg
- Housing: individually, in suspended metal cages
- Diet: ad libitum (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol, United Kingdom)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 58-66
- Air changes (per hr): appr. 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 02JUL1992 to 09JUL1992

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye was used as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1mL
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

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

TOOL USED TO ASSESS SCORE: standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritant / corrosive response data:
No adverse corneal or iridial effects were noted. Minimal conjunctival irritation was noted in two animals one hour after treatment (score 1), this effect resolved within 24 hours. No other adverse ocular effects were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An acute eye irritation test was performed with 3 rabbits according to OECD/EC guideline. As no adverse effects were seen in the treated eyes at 24, 48 and 72 hours, PEMP was found to be not irritating to the eye.
Executive summary:

An acute eye irritation test was performed with 3 rabbits according to OECD/EC guideline. Minimal conjunctival irritation was noted in two animals one hour after treatment (score 1), this effect resolved within 24 hours.No adverse corneal or iridial effects were noted at any timepoint. No other effects were noted. Based on the results of this study, PEMP was found to be not irritating to the eye.