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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:
August 14, 1989 - August 28, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performe according to OECD guideline and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bisisobutyryl peroxide
EC Number:
222-340-0
EC Name:
Bisisobutyryl peroxide
Cas Number:
3437-84-1
Molecular formula:
C8H14O4
IUPAC Name:
2-methylpropanoyl 2-methylpropaneperoxoate
Details on test material:
Appearance:a clear, slightly viscous liquid
Batch No: 130789
Subsatnce ID: "Trigonox 187-C30, ex ch 130789""
Chemical name: Diisobutyrylperoxide.
Active ingredient and purity: diisobutyrylperoxide 30%
Trade name: Trigonox 187-C30,
cas Reg. no.: 3437-84-1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, the Netherlands
- Age at study initiation: young adult
- Weight at study initiation: 2604 g
- Housing: The animal was housed in a suspended, galvanized cage, fitted with a wire-mesh floor and front
- Diet (e.g. ad libitum): standard laboratory rabbit diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): at least 40%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): natural day/night cycle

IN-LIFE DATES: August 14, 1989 - August 28, 1989

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye remaining untreated, served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
Ocular reactions were judged at circa one hour, at circa 24, 48, 72 hours, and at 8, and 14 days after treatment
Number of animals or in vitro replicates:
1, 1, the effects were of a very severe degree. Therefore, it was decided not to continue the study with another two rabbits.
Details on study design:
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: No data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: ischemic necrosis of the conjunctivae
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
other: ocular discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14-days
Irritant / corrosive response data:
Approximately one minute after treatment the animal began to scream for about one minute. This screaming is considered to be a clear sign of pain due to treatment with the test substance.
At one hour after treatment, the eye effects observed consisted of moderate redness of the conjunctivae, severe swelling of the conjunctivae. In addition, moderate ocular discharge was observed. At 24 hours after treatment, the eye effects observed consisted of slight corneal opacity, slight iritis, severe redness of the conjunctivae, severe swelling of the conjunctivae, ischemic necrosis of the conjunctivae, and severe ocular discharge. At 48 and 72 hours after treatment, the eye effects observed consisted of moderate corneal opacity, slight iritis, severe redness of the conjunctivae, severe swelling of the conjunctivae, ischemic necrosis of the conjunctivae, and severe ocular discharge. During the following five days, the eye effects partly cleared. At 8 days after treatment, the eye effects observed consisted of slight corneal opacity, slight redness of the conjunctivae, slight swelling of the conjunctivae, and slight ocular discharge. At 14 days after treatment, the eye effects had cleared completely.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
The results for 30% diisobutyryl peroxide in a solvent would result in a classification as irritating to the eyes.
Executive summary:

A 30% dilution of diisobutyIyl peroxide was examined for acute eye irritating/corrosive properties in an experiment with one albino rabbit.

The test substance caused moderate corneal opacity, slight iritis, severe redness of the conjunctivae, severe swelling of the conjunctivae, ischemic necrosis of the conjunctivae, and severe ocular discharge.

At 14 days after treatment, the eye effects had cleared completely. Because of the severe degree of the effects observed and for ethical

reasons, it was decided to use for this study only one animal instead of three.

On thee basis of the results obtained it was concluded that, under the conditions of this study, a 30% dilution of diisobutyIyl peroxide is irritating, but not corrosive to eyes.

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