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Diss Factsheets

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:
2-5 August 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentaerythritol tetrakis(3-mercaptopropionate)
EC Number:
231-472-8
EC Name:
Pentaerythritol tetrakis(3-mercaptopropionate)
Cas Number:
7575-23-7
Molecular formula:
C17H28O8S4
IUPAC Name:
3-[(3-sulfanylpropanoyl)oxy]-2,2-bis{[(3-sulfanylpropanoyl)oxy]methyl}propyl 3-sulfanylpropanoate
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France.
- Age at study initiation: 2 to 4 months
- Weight at study initiation: 2.5 ± 0.1 kg.
- Housing: individually in polystyrene cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2002-08-02 To: 2002-08-05

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 µL
Duration of treatment / exposure:
Eyes were not rinsed
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
1+2
Details on study design:
REMOVAL OF TEST SUBSTANCE: no

SCORING SYSTEM: as laid down in OECD 405

TOOL USED TO ASSESS SCORE: UV lamp / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Only very slight conjunctival reactions, including very slight chemosis (grade 1), very slight redness of the conjunctiva (grade 1) and clear discharge, were observed in all animals on day 1.
No other ocular reactions were observed during the study. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for chemosis, redness of the conjunctiva, iris lesions and corneal opacity.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
PETMP is not irritating to eyes
Executive summary:

The potential of the test item PETMP to induce ocular irritation was evaluated in rabbits according to OECD (No. 405, 24th February 1987) and EC (92/69/EEC, B.5,31st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

A single dose of 0.1 mL of the undiluted test item was instilled into the left conjunctival sac of three male New Zealand White rabbits. The right eye was not treated and served as control. The eyes were not rinsed after administration of the test item. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.

Only very slight conjunctival reactions (very slight chemosis, very slight redness of the conjunctiva and clear discharge) were observed in all animals on day 1. No other ocular reactions were observed during the study. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for chemosis, redness of the conjunctiva, iris lesions and corneal opacity.

Under our experimental conditions, the test item PETMP is non-irritant when administered by ocular route to rabbits.