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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well performed GLP study according to recent OECD TG.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
April 24, 2002
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
April 29. 2004
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-1,4-phenylenebis[3-oxobutyramide]
EC Number:
246-438-8
EC Name:
N,N'-1,4-phenylenebis[3-oxobutyramide]
Cas Number:
24731-73-5
Molecular formula:
C14H16N2O4
IUPAC Name:
3-oxo-N-[4-(3-oxobutanamido)phenyl]butanamide
Details on test material:
- Name of test material (as cited in study report): Diacetessig - p - phenylendiamid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
-Test system: Young Adult New Zealand White Rabbit, SPF
- Rationale: Recognized by the international guidelines as the recommended test system.
- Source: Charles River Deutschland GmbH, Stolzenseeweg 32-36, D-88353 Kisslegg / Germany
- Number of animals per test: 3 (Animals of both sexes were used)
- Age at treatment: 13 weeks (male) and 13 - 16 weeks (females)
- Identification: By unique cage number and corresponding ear number.
- Acclimatization: Only animals without any visual signs of illness were used for the study.
- Allocation: Male No. 43 and Female Nos. 44 and 45
- Room number: 0221 / RCC Ltd, Füllinsdorf
- Conditions: Standard Laboratory Conditions
- Air-conditioned with ranges for room temperature 17-23 °C, relative humidity 30-70 % and approx. 10-15 air changes per hour.
- Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC.
- The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the daytime light period.
- Accommodation: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 35/05, Provimi Kliba AG) were provided for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 34/05) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Results of analysis for contami¬nants are archived at RCC Ltd.
- Water: Community tap water from Füllinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as the reference control.
Amount / concentration applied:
0.1 g (per animal) of pulverized test item was weighed and applied undiluted (unchanged, no vehicle).
Duration of treatment / exposure:
single treatment, the treated eyes were not rinsed after instillation
Observation period (in vivo):
Examinations were performed at 1 hr, 24 hrs, 48 hrs and 72 hrs after instillation or the test item.
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #43
Time point:
other: mean of 24 hrs, 48 hrs, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (cornea) at any time
Irritation parameter:
iris score
Basis:
animal: #43
Time point:
other: mean of 24 hrs, 48 hrs, 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) at any time
Irritation parameter:
conjunctivae score
Basis:
animal: #43
Time point:
other: mean of 24 hrs, 48 hrs, 72 hrs
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
animal: #43
Time point:
other: mean of 24 hrs, 48 hrs, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: initial slight reactions were fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal: #44
Time point:
other: mean of 24 hrs, 48 hrs, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (cornea) at any time
Irritation parameter:
iris score
Basis:
animal: #44
Time point:
other: mean of 24 hrs, 48 hrs, 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) at any time
Irritation parameter:
conjunctivae score
Basis:
animal: #44
Time point:
other: mean of 24 hrs, 48 hrs, 72 hrs
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
animal: #44
Time point:
other: mean of 24 hrs, 48 hrs, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: initial slight reactions were fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal: #45
Time point:
other: mean of 24 hrs, 48 hrs, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (cornea) at any time
Irritation parameter:
iris score
Basis:
animal: #45
Time point:
other: mean of 24 hrs, 48 hrs, 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) at any time
Irritation parameter:
conjunctivae score
Basis:
animal: #45
Time point:
other: mean of 24 hrs, 48 hrs, 72 hrs
Score:
0
Max. score:
3
Reversibility:
other: initial slight reactions were fully reversible
Irritation parameter:
chemosis score
Basis:
animal: #45
Time point:
other: mean of 24 hrs, 48 hrs, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: initial slight reactions were fully reversible
Irritant / corrosive response data:

IRRITATION
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.67, 0.67 and 0.00 for reddening and 0.00 for chemosis for all three animals, respectively.
No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.
Moderate reddening of the conjunctivae was noted in all animals at the 1-hour reading and slight reddening persisted in two animals until the 48-hour examination.
Slight swelling (chemosis) of the conjunctivae was observed in all animals at the 1-hour reading.
Moderate reddening of the sclerae was present in all animals at the 1-hour reading. Slight ocular discharge was observed in all animals at the 1-hour reading.
No abnormal findings were observed in the treated eye of any animal 72 hours after treatment, the end of the observation period for all animals.

COLORATION
Gray remnants of the test item were observed in the eye or conjunctival sac of all animals one hour after treatment.

CORROSION
No corrosion of the cornea was observed at any of the reading times.
Other effects:
VIABILITY/MORTALITY AND CLINICAL SIGNS
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

Any other information on results incl. tables

BODY WEIGHTS

The body weights of all rabbits were considered to be within the normal range of variability.

Body weight in grams

Animal
No.

Sex

First Day of
Acclimatization

Day of
Treatment

Last Day of Observation

43

male

2425

2571

2656

44

female

3067

3189

3268

45

female

2968

3093

3236

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based upon the referred classification (Commission Directive 200 1/59/EC of August 06, 2001), Diacetessig - p - phenylendiamid is considered to be “not irritating” to the rabbit eye.
Executive summary:

The primary eye irritation potential of Diacetessig - p - phenylendiamid was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.67, 0.67 and 0.00 for reddening and 0.00 for chemosis for all three animals, respectively.

The instillation of Diacetessig - p - phenylendiamid into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 72 hours after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test itemand no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye.

Based upon the referred classification criteria (Commission Directive 2001/59/EC ofAugust 06, 2001), Diacetessig - p - phenylendiamid is considered to be “not irritating” to the rabbit eye.