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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:
April to June 1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Remarks:
Test procedure in accordance with generally accepted scientific standards and described in sufficient detail. Applicant assessment indicates that any deviation from current guidelines would not have affected the study outcome.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Recognised supplier
- Age at study initiation: unspecified
- Weight at study initiation: 3 - 4 kg
- Housing: individually housed in rabbit cages.
- Diet: Standard mixed rabbit food, ad libitum.
- Water: Water, ad libitum
- Acclimation period: Time not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Unspecified; ambient laboratory temperature.
- Humidity (%): Unspecified; ambient laboratory humidity.
- Air changes (per hr): Unspecified.
- Photoperiod (hrs dark / hrs light): Unspecified.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg (per animal)
- Concentration (if solution): undiluted
Duration of treatment / exposure:
A quantity of 50 mg of the undiluted test material, was placed into the conjunctival sac of one eye. The other eye remained untreated.
Observation period (in vivo):
Ocular assessment was conducted daily over the following 7 days.
Number of animals or in vitro replicates:
2 (1 male and 1 female).
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Unspecified; applicant assessment: assumed none.

SCORING SYSTEM:
The ocular reaction was described in the report in prose at daily intervals after instillation, for the following 7 days. Applicant assessment indicates that the prose description contains sufficient detail for the results to be interpreted according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992. This scoring system is consistent with Draize scoring system. When present, corrosion and/or staining of conjunctivae, sclerae and cornea by the test item were recorded and reported.

TOOL USED TO ASSESS SCORE: Eye examinations were made manually, equipment details are unspecified. Applicant assessment indicates that no special equipment would be necessary to determine the outcome of the study (from the description, the results would have been clearly visible to the naked eye).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 0 - 7d
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: mean; n=2. Cornea totally corroded.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 0 - 6d
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: mean; n=2. Strong reddening.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
7 d
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: mean; n=2. Moderate reddening.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 0 - 6d
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: mean; n=2. Strong reddening.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
7 d
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: mean; n=2. Moderate reddening.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 0 - 7d
Max. score:
4
Remarks on result:
not measured/tested
Remarks:
Iris observations not reported; Applicant assessment indicates this would have been deemed either not possible or unnecessary due to severe corneal corrosion.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Indication of corrosion
Remarks:
Cornea totally corroded
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Indication of corrosion
Remarks:
Cornea totally corroded
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Severe reddening
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Severe reddening
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Strong reddening
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Strong reddening
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
not measured/tested
Remarks:
Iris observations not reported; Applicant assessment indicates this would have been deemed either not possible or unnecessary due to severe corneal corrosion, thereby not having any effect on the classification of the substance.
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
not measured/tested
Remarks:
Iris observations not reported; Applicant assessment indicates this would have been deemed either not possible or unnecessary due to severe corneal corrosion, thereby not having any effect on the classification of the substance.
Irritant / corrosive response data:
"Total corrosion" of the cornea was noted at all observations. "Strong reddening" of the conjunctivae of treated eyes was observed immediately and for the following 6 days after treatment, although partially resolved to "moderate reddening" by the final observation. "Strong" chemosis of the conjunctivae was observed in both animals immediately after treatment, for the following 6 days, which reduced to "moderate" chemosis by the final observation. An iris score was not recorded in the study report. Applicant assessment indicates that this would not change the classification of the substance.
Other effects:
- Lesions and clinical observations: Total corrosion of the cornea; strong irritation of the conjunctiva with only partial reversal by the end of the study.
- Ophthalmoscopic findings: None reported.
- Histopathological findings: Not applicable.
- Effects of rinsing or washing: Not applicable.
- Other observations: Not applicable.

Any other information on results incl. tables

Table 1. Individual scores and mean scores for the 7 day observation period

Organism number 1 2
Time After Treatment 0 - 6 days 7 days 0 - 6 days 7 days
CORNEA



Degree of Opacity 4 4 4 4
Mean (24 – 72 h)








Area of Cornea Involved 4 4 4 4





IRIS Not assessed Not assessed Not assessed Not assessed
Mean (24 – 72 h)








CONJUNCTIVAE



Redness 3 2 3 2
Mean (24 – 72 h)








Chemosis 4 3 4 3
Mean (24 – 72 h)








Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item is strongly irritating and corrosive to the eye.
Executive summary:

The study was performed historically to a guideline similar to OECD TG 405 and EU Method B.5 to assess the irritancy potential of the test item to the eye following a single application in the New Zealand White rabbit. Applicant assessment indicates that any deviation from the current guidelines would not have a significant effect on the study outcome. A volume of 50 mg of the test material was placed into the conjunctival sac of one eye of two rabbits. The other eye remained untreated. Assessment of ocular damage/irritation was made daily for 7 days following treatment. A single application of the test item to the non-irrigated eye of two rabbits produced immediate total corrosion of the cornea. "Strong" redness of the conjunctivae was observed in all treated eyes immediately after treatment, which persisted for 6 days. This reduced to "moderate" redness by the final (day 7) observation. "Strong" chemosis was observed in both treated eyes immediately after treatment, persisting for the following 6 days. This reduced to "moderate" chemosis by the final (day 7) observation. The study authors note "Aufgrund der stark ausgepraegten Reiz- und Aetzwirkung ist jedoch jeder Haut- und Schleimhautkontakt (Auge) mit dem Pruefmuster unbedingth zu vermeiden.", i.e. "Due to the pronounced irritant and caustic effect, any skin and mucous-membrane contact (eye) with the test item must be avoided." Furthermore, the authors note, "...jeglicher Haut- und Schleimhautkontakt (Auge) ist unbedingt zu vermeiden.", i.e. "any contact with skin or mucous membranes (eye) should be avoided at all costs". Under the conditions of this study, the test item is therefore considered to be strongly irritating and corrosive to the eye.