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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:
from 16-FEB-94 to 19-FEB-94
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1-phenyloctadecane-1,3-dione and phenylicosane-1,3-dione
EC Number:
915-316-2
Molecular formula:
C50H80O4
IUPAC Name:
Reaction mass of 1-phenyloctadecane-1,3-dione and phenylicosane-1,3-dione

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS:
- Source: Elevage Cunicole de Val de Selle (80160 Prouzel, France)
- Age at study initiation: no data
- Weight at study initiation: 2.8 +- 0.4 kg
- Housing: individually in polystyrene cages (35 x55 x32 cm or 48.2 x 58 x 36.5 cm)
- Diet: 112C pelleted diet (UAR 91360 Villemoisson -sur-Orge,France), ad libitum.
Composition and contaminants analysis performed by the supplier.
- Water: filtered drinking water (0.22 µm), ad libitum; Bacteriological and chemical analysis performed periodically by the C.I.T.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS:
- Temperature: 18 +- 3°C
- Humidity: 30-70 %
- Air changes: no data
- Photoperiod: 12h light-dark cycle

IN-LIFE DATES: from 16-FEB-1994 to 19-FEB-1994

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of cream coloured powder
- Concentration (if solution): not applicable
Duration of treatment / exposure:
The test substance was instillated into the conjunctival sac of the right eye of each rabbit.
Scoring was performed at 24, 48, 72 hours, then on day 7 and 14 if necessary (presence of ocular lesions)

- Control animals: other: the left eye remained untreated and served as the control
- Removal of test system: no
- Scoring system: according to the Draize scale at 24, 48, 72 hours, then at 7 days as well as 14 days after the instillation if necessary
- Tool used to assess score: to determine the presence or absence of corneal opacity and to evaluate the affected area, 1 or 2 drops of 0.5 % sodium fluorescein solution can be instilled into the eye. In case of difficulty, the eye can be examined under a U.V. lamp.
Observation period (in vivo):
3 days (no ocular lesions observed at 72 hours)
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: /


SCORING SYSTEM: according to the Draize scale at 24, 48, 72 hours, then at 7 days as well as 14 days after the instillation if necessary


TOOL USED TO ASSESS SCORE: to determine the presence or absence of corneal opacity and to evaluate the affected area, 1 or 2 drops of 0.5 % sodium fluorescein solution can be instilled into the eye. In case of difficulty, the eye can be examined under a U.V. lamp.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.57
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Mean individual scores: 1-0-0.7
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Mean individual scores: 0.3-0-0

Any other information on results incl. tables

Table 7.3.2/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

24 h

0/0/0

0/0/0

2/0/1

1/0/0

48 h

0/0/0

0/0/0

1/0/1

0/0/0

72 h

0/0/0

0/0/0

0/0/0

0/0/0

Average 24h, 48h, 72h

0-0-0

0-0-0

1-0-0.7

0.3-0-0

Reversibility*)

-

-

c.

c.

Average time (unit) for reversion

-

-

72 h.

48 h.

*)Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The reaction mass of Stearoylbenzoylmethane and Palmitoylbenzoylmethane is not classified as eye irritant according to Annex VI of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).
Executive summary:

Rhodiastab X5 has been tested for acute ocular irritation on 3 New-Zealand White rabbits, according to O.E.C.D. guideline Nb.405 and in compliance with Good Laboratory Practice. The test substance was instilled as supplied in a single dose of0.1 g, into the conjunctival sac of the left eye of the animals. The eyes were not rinsed after the instillation. Ocular examinations were performed 1, 24, 48 and 72 hours after the administration. The mean individual score values were calculated for 24, 48 and 72 hours.

Slight to moderate conjunctival irritation
 (scores of 1 or 2 for chemosis and redness) occurred in all animalsat 1hour. Only one animal still showed chemosis (score 1) and redness (score 2) at 24 hours while the second animal showed only slight redness (score 1) without chemosis and the third didn't show any ocular lesions. Slight redness (score 1) was still observed up to 48 hour in both rabbits.
No iridial lesions or opacity of the cornea were observed. A discharge (score 1 or 2) was noted
at 1hour in all animals, and up to 24 hours in one animal with whitish purulent discharge.

Based on these results, the reaction mass of Stearoylbenzoylmethane and Palmitoylbenzoylmethane is not classified as eye irritant according to Annex VI of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).