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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:
3 Mar - 6 Mar 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Methods applied similar to OECD405

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no recovery period, scoring according to FDA
Qualifier:
according to
Guideline:
other: FDA Guideline, Register 38 No. 187, 27.09.1973, p 27019
Deviations:
no
GLP compliance:
no
Remarks:
study performed before GLP guidelines

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
white powder

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG own breed (Hoe:HIMK (SPFWiga)
- Weight at study initiation: 1.9-2.3 kg
- Housing: single cages
- Diet (e.g. ad libitum): ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westf.) ad libitum
- Water (e.g. ad libitum): ad libitum


IN-LIFE DATES: From: 3 March To: 6 March 1980

Test system

Vehicle:
other: moistened by sesame oil or 0.1 mL PEG 400
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1, 7, 24, 48and 72 hours after application
Number of animals or in vitro replicates:
6 animals (no. 1 - 6) for moistening with sesame oil
6 animals (no. 7-12) for moistening with PEG 400
Details on study design:
The eyes were examined 1, 7, 24, 48 and 72 hours after application of the test substance.
24 hours after treatment the eyes were washed out with physological saline.
At 48 and 72 hours the eyes were also examined after instillation of one drop of 0.01 % fluorescein-sodium solution.

SCORING SYSTEM:

A. CORNEA
Degree of opacity (most dense area used)
No opacity ...................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible........................................1
Easily discernible translucent areas, details of iris slightly obscured................2
Opalescent areas, no details of iris visible , size of pupil barely discernible ....3
Opaque, iris invisible, ulzeration ..............................................................................4

B. Affected area
1 = punctiform up to 1/4 but not 0
2 = more than 1/4 up to 1/2
3 = more than 1/2 up to 3/4
4 = more than 3/4 up t o 4/4

a = A x B x 5 (max 80)

IRIS
Normal ......................................................................................................................... 0
Folds above normal , congestion, swelling, circumcorneal injection (any of all of these or combination of any thereof); iris still reacting to light
(sluggish reaction is positive) ......................... .........................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these) ......2

b = Value x 5 (max. 10)

CONJUNCTIVAE

A. Redness
Blood vessels normal...............................................................................................................0
Blood vessels definitely injected above normal ................................................................. 1
More diffuse, deeper crimson red, individual blood vessels not easily discernible .....2
Diffuse beefy red......................................................................................................................3

B. Chemosi s (refers to palpebral and bulbar conjunctivae)
No swelling .........................................................................................0
Any swelling above normal (includes nictitating membran) ..... 1
Obvious swelling with partial eversion of l i d s ...........................2
Swelling with lids about half closed ................................................3
Swelling with lids half closed to completely closed.......................4

C. Secretion
No secretion......................................................................................................................0
Any secretion above normal...........................................................................................1
Secretion with wetting of palpebra and hair close to palpebra.................................2
Secretion with wetting of palpebra, hair and considerable area around eyes........3

c = (A+B+C) x 2 (max. 20)

For each animal the ratings for cornea (a), iris (b) and conjunctivae (c) were added for the respective time of observation. For each time of observation the mean value was calculated for all animals. The highest determined irritation score for any time of observation was used for classification according following evaluation classes:

0-10..........non irritant
11-25.......slightly irritant
26-56.......moderately irritant
57-110.....severely irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Remarks:
Individual scores are provided in tabular (refer to "Any other information on results incl. tables")
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animals 7-12
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Remarks:
Individual scores are provided in tabular (refer to "Any other information on results incl. tables")
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1-6
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Remarks:
Individual scores are provided in tabular (refer to "Any other information on results incl. tables")
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 7-12
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Remarks:
Individual scores are provided in tabular (refer to "Any other information on results incl. tables")
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 1-6
Time point:
other: 24, 48, 72 h
Score:
1.4
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks:
3 rabbits out of 6 had decreasing score of 1 or 2
Remarks on result:
other: Methodically not longer observed, but full reversibility is expected after 14 days.
Remarks:
Individual scores are provided in tabular (refer to "Any other information on results incl. tables")
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 7-12
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks:
3 rabbits out of 6 had decreasing score of 1
Remarks on result:
other: Methodically not longer observed, but full reversibility is expected after 14 days.
Remarks:
Individual scores are provided in tabular (refer to "Any other information on results incl. tables")
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1-6
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
2
Reversibility:
not fully reversible within: 72h
Remarks:
1 rabbit out of 6 had a score of 1
Remarks on result:
other: Methodically not longer observed, but full reversibility is expected after 14 days.
Remarks:
Individual scores are provided in tabular (refer to "Any other information on results incl. tables")
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 7-12
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
1
Reversibility:
not fully reversible within: 72 h
Remarks:
1 rabbit out of 6 had a score of 1
Remarks on result:
other: Methodically not longer observed, but full reversibility is expected after 14 days.
Remarks:
Individual scores are provided in tabular (refer to "Any other information on results incl. tables")

Any other information on results incl. tables

1.     Irritation scores (Vehicle: Sesame oil)

Time post appl.

24 h

48 h

72 h

Animal number

1

2

3

4

5

6

1

2

3

4

5

6

1

2

3

4

5

6

Cornea score

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Iris score

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Conjunctivae score

2

2

3

3

2

2

1

1

2

2

1

1

1

0

2

1

0

0

Chemosis sore

1

1

2

2

1

1

0

0

2

1

0

0

0

0

1

0

0

0

 

2.     Irritation scores (Vehicle: PEG 400)

Time post appl.

24 h

48 h

72 h

Animal number

7

8

9

10

11

12

7

8

9

10

11

12

7

8

9

10

11

12

Cornea score

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Iris score

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Conjunctivae score

2

1

1

1

1

1

2

1

1

1

1

1

0

0

1

0

1

1

Chemosis sore

0

1

1

0

1

1

0

0

0

0

0

1

0

0

0

0

0

1

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
With reference the reported scores and the reported trend to decreasing severity of effects within 72 h Hostanox O 3 does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Executive summary:

Hostanox O 3 was tested for its eye irritant properties in 6 Albino-Himalayan rabbits. The study was performed according to OECD Guideline 405. The only deviation was the absence of the recovery period of 14 days.

Effects on conjunctivae (redness and swelling) were observed in all animals one hour after application. These signs decreased significantly within 72 hours and full reversibility is assumed occur after 14 days recovery.

With reference the reported scores and the reported trend to decreasing severity of effects within 72 h Hostanox O 3 does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).