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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:
September 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Bernardy, batch No 1601762
- Expiration date of the lot/batch: 29 September 2019
- Production date: 29 September 2016
- Purity test date: 30 September 2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Stable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was used after being reduced in fine powder in the study.

FORM AS APPLIED IN THE TEST
As such.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
Female
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: supplied by C.E.G.A.V (La Passerie, F-61350 Saint Martin d’Egrenne).
- Age at study initiation: 10 or 11 weeks old
- Housing: individual box installed in conventional air-conditioned animal husbanding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5-day acclimatisation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17°C to 23°C
- Humidity (%): 30% to 70%
- Air changes (per hr): at least ten changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (07.00 to 19.00) and twelve hours darkness

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
As recommanded in the OECD Guideline, the other eye remained untreated serving as control.
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g of the test item was instilled, after being reduced in fine powder, into the conjunctival sac of one eye after gently pulling the lower lid away from the eyeball.

VEHICLE
No vehicle used
Observation period (in vivo):
1 hour, 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No washing
- Time after start of exposure: Residual test item requiring a physiological saline rinse off was noted at the reading time 1 hour in all animals.

SCORING SYSTEM:
As recommanded by the OECD Guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
The ocular reactions observed during the study have been slight to moderate and totally reversible:
- at the conjunctivae level: a slight to moderate redness noted 1 hour after the test item instillation in all animal and totally reversible between days 1 and 2. This reaction was associated with a slight to moderate chemosis noted 1 hour after the test item instillation and totally reversible between days 1 and 2.
- at the iris level: an injection noted 1 hour after the test item instillation in two animals and totally reversible on day 1.

Any other information on results incl. tables

Animal n°

Weiht (kg)

Time after treatment

CONJUCTIVAE

IRIS

CORNEA

CHEMOSIS (A)

REDNESS (C)

LESION (D)

OPACITY (E)

A7107

24 hours

1

1

0

0

48 hours

0

0

0

0

72 hours

0

0

0

0

Start: 2.32

TOTAL

1

1

0

0

End: 2.42

Mean

0.3

0.3

0.0

0.0

A7118

24 hours

0

0

0

0

48 hours

0

0

0

0

72 hours

0

0

0

0

Start: 2.19

TOTAL

0

0

0

0

End: 2.28

Mean

0.0

0.0

0.0

0.0

A7119

24 hours

0

0

0

0

48 hours

0

0

0

0

72 hours

0

0

0

0

Start: 2.27

TOTAL

0

0

0

0

End: 2.35

Mean

0.0

0.0

0.0

0.0

CLASSIFICATION

According to the calculated means, the test item does not have to be classified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The results obtained, under these experimental conditions, enable to conclude that the test item Magnesium oxalate does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No symbol and warning label are required.
Executive summary:

The test item Magnesium oxalate was instilled, as supplied, into the eye of three New Zealand rabbits at the dose of 0.1 g.

The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. Test Guideline No. 405 dated October 9th, 2017.

The ocular reactions observed during the study have been slight to moderate and totally reversible:

- at the conjunctivae level: a slight to moderate redness noted 1 hour after the test item instillation in all animal and totally reversible between days 1 and 2. This reaction was associated with a slight

to moderate chemosis noted 1 hour after the test item instillation and totally reversible between days 1 and 2.

- at the iris level: an injection noted 1 hour after the test item instillation in two animals and totally reversible on day 1.

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item Magnesium oxalate does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.

No symbol and warning label are required.