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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:
12-15 November 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
GLP study conducted in compliance with OECD Guideline 405 with minor deviations: non-ocular local and systemic adverse effects not followed; individual animal weights not reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
dated 24 February 1987
Deviations:
yes
Remarks:
non-ocular local and systemic adverse effects not followed; individual animal weights not reported
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
dated 31 July 1992
Deviations:
yes
Remarks:
non-ocular local and systemic adverse effects not followed; individual animal weights not reported
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes
Remarks:
whitish flakes
Details on test material:
- Expiration date of the lot/batch: 18 November 2001
- Purity test date: 27 January 2000
- Storage condition of test material: At room temperature protected from light and humidity; in its original packaging
- pH at the concentration of 10% in purified water: 7
Specific details on test material used for the study:
Date of receipt: 21 September 2001
Name as cited in the report: TECHNICAL AMITROLE

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: CEGAV specialised breeding establishment (Les Hautes Noes, Saint Mars d'Egrenne, 61350 PASSAIS LA CONCEPTION, FRANCE)
- Weight at study initiation: 2.7-2.9 kg
- Housing: Animals were kept in cages of standard size.
- Diet (e.g. ad libitum): UAR 112 foodstuff (Usine d'Alimentation Rationnele, EPINAY-SUR-ORGE - FRANCE), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-21°C
- Humidity: 45-65%
- Air changes: 10 per hour
- Photoperiod: 12 hours dark/12 hours light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was gently irrigated, approximately 30 seconds following instillation of the test substance, with 100 mL of sterile isotonic saline solution. Irrigation performed over a period of approximately 30 seconds.
- Time after start of exposure: 30 seconds

SCORING SYSTEM: According to OECD Guideline 405

TOOL USED TO ASSESS SCORE: Confirmation of the presence or absence of corneal opacity was carried out (except for reading at time one hour) by examination after instillation of a 2% aqueous solution of sodium fluorescein and rinsing with sterile and pyrogen free isotonic saline.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
- Conjunctivae redness (grade 1) was noted in all animals at 1 hour after exposure; completely reversible within 24 hours. No other ocular reactions were observed.
Other effects:
None

Any other information on results incl. tables

Table 7.3.2/1: Ocular irritation results

Rabbit No.

Region of eye

Scores

1 hour

24 hours

48 hours

72 hours

Mean (24, 48 & 72 hours)

1

Conjunctivae: Chemosis

0

0

0

0

0

Conjunctivae: Redness

1

0

0

0

0

Iris

0

0

0

0

0

Corneal opacity

0

0

0

0

0

2

Conjunctivae: Chemosis

0

0

0

0

0

Conjunctivae: Redness

1

0

0

0

0

Iris

0

0

0

0

0

Corneal opacity

0

0

0

0

0

3

Conjunctivae: Chemosis

0

0

0

0

0

Conjunctivae: Redness

1

0

0

0

0

Iris

0

0

0

0

0

Corneal opacity

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions and in accordance with Regulation EC No. 1272/2008 (CLP), the test item was considered as non-irritant to eye. It corresponds to UN GHS No Category. No hazard statement or signal word is required.
Executive summary:

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 0.1 g of the test item was instilled into the conjunctival sac of the left eye of each of the three female New Zealand white rabbits used. The untreated right eye served as a control. The treated eye was gently irrigated, approximately 30 seconds following instillation of the test substance, with 100 mL of sterile isotonic saline solution. Any conjunctival, iris and corneal lesions were evaluated approximately 1, 24, 48 and 72 hours after instillation. Mean indices were calculated from results obtained for each rabbit at times 24, 48 and 72 hours.

Conjunctivae redness (grade 1) was noted in all animals at 1 hour after exposure; completely reversible within 24 hours. No other ocular reactions were observed. Mean individual scores at 24, 48 and 72 hours after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0, 0, 0 for conjunctivae score and 0, 0, 0 for chemosis score.

Under the test conditions and in accordance with Regulation EC No. 1272/2008 (CLP), the test item was considered as non-irritant to eye. It corresponds to UN GHS No Category. No hazard statement or signal word is required.