Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-12-15 to 1991-02-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is well described and performed according to OECD testing guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: viscous liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Elevage Cunicole du Val de Selle, 80160 Prouzel, FRANCE.
- Weight at study initiation: average weight 2.7 ± 0.1 kg of the 3 males at the start of the experiment .
- Housing: Upon receipt, the animals received a preventive treatment for coccidiosis by administration of a Mucoxid (R) solution at the dose of 137.5 mg/kg/d at a volume of 10 ml/kg (Véda-Cogla, 45140 Saint Jean de la Ruelle, FRANCE). Observation was performed at the time of delivery of the animals and daily during the acclimatisation period. Animals were housed individually in cages of standard size. These cages were placed in an air-conditioned (20 ± 3°C) animal house kept at between 50 ± 20 % relative humidity. These parameters are recorded in each room. Non recycled air is filtered by absolute filters. The artificial day/night cycle was 12 hours light and 12 hours darkness.
- Diet (e.g. ad libitum): "Rabbits sustenance 112 C" from U.A.R. 91360 VILLEMOISSON SUR ORGE, was available ad libitum. A certificate of analysis (including the main contaminants) is provided by the supplier for every batch.
- Water (e.g. ad libitum): free access to tap water filtered by 0.22 micron filter membrane. Drinking water was available ad libitum in bottles. A specimen of water is regularly sent to a laboratory for bacteriological and chemical analysis (Laboratoire Municipal et Régional de Rouen, 76000 ROUEN, FRANCE.
- Acclimation period:For at least 5 days before the treatment, in the area where the experiment took place.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: undiluted
Duration of treatment / exposure:
one instillation (not rinsed)
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3 animals
Details on study design:
The test substance was first administred to 1 animal. As the substance was not irritant, the two additionnal animals were also tested.
The eyes were not rinced after administration of the substance.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.78
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
At 1 hour and 24h : slight to moderate conjunctival reactions (chemosis: mean score 0.3 to 1.7 and enanthema : mean score 1 to 1.7). Lachrymation was marked in 1 animal after 24h.
At 48h : slight enanthema (score 1) in 2 animal with a slight discharge in 1 animal
at 72h : no reaction.

Any other information on results incl. tables

Mean value calculated from the scores recorded after 24, 48 and 72 hours for each animal

 

Animal

Maximum score per site

01

02

03

Chemosis

0.3

0

0

1 after 24h

Redness of the conjunctiva

1.0

0.3

1.0

2 after 24 hours

Iridic lesions

0

0

0

 

Degree of corneal opacity

0

0

0

 

Scores in the 3 animals at 1, 24, 48 and 72 hours

 

1 hour

24 hours

48 hours

72 hours

Chemosis

2/1/2

1/0/0

0/0/0

0/0/0

Redness of the conjunctiva

1/1/1

2/1/2

1/0/1

0/0/0

Iridic lesions

0/0/0

0/0/0

0/0/0

0/0/0

Degree of corneal opacity

0/0/0

0/0/0

0/0/0

0/0/0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance Glyoxalate d'Ethyle (HF 7846) is not irritating to eye.
Executive summary:

The substance Glyoxalate d'Ethyle (HF 7846) was tested for eye irritation / corrosion in rabbits according to OECD guideline n°405 and Good Laboratory Practices.

All scores are equal to 0, except for chemosis (mean score 0.3 to 1.7) and conjunctival redness (mean score 1 to 1.7). After 48h only a slight enanthema persist in 2 animals and at 72 hours no further ocular reactions were observed.

On the basis of these results, the Glyoxalate d'Ethyle (HF 7846) is not considered as irritating to the eye according the CLP Regulation No. 1272/2008.