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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:
From July 23 to 27, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Study was performed according to modified Draize procedure (Draize, 1975).
GLP compliance:
no
Remarks:
pre-GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Source: Firmenich Incorporated

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: About 3 months
- Weight at study initiation: Approximately 2 kg
- Housing: Animals were housed in galvanized or stainless steel cages.
- Diet: Diet consisted of a growth and maintenance ration from a commercial producer, ad libitum
- Water, ad libitum
- Acclimation period: 3 days

IN-LIFE DATES: From: July 23, 1979 To: July 27, 1979

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
The eyes of all animals remained unwashed for 24 h.
Observation period (in vivo):
24, 48, and 72 h following instillation of the test material
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: According to Draize scale.

TOOL USED TO ASSESS SCORE: No data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
other: 24, 48 and 72 h
Score:
0.06
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
other: 24, 48 and 72 h
Score:
0.06
Max. score:
2
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
other: 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
other: 24, 48 and 72 h
Score:
0.44
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritant / corrosive response data:
Animals showed corneal and iridial reactions which were reversible within 2 days. Conjunctival reactions (redness and chemosis) were reversible within 3 days.
Other effects:
None

Any other information on results incl. tables

Table 7.3.2/1: Mean eye irritation response data of 6 animals at each observation time

Score at time point / Reversibility

Cornea

Iris

(/2)

Conjunctivae

Opacity

(/4)

Area

(/4)

Redness

(/3)

Chemosis

(/4)

Discharge

(/3)

24 h (Day 1)

0.17

0.17

0.17

0.83

1

0

48 h (Day 2)

0

0

0

0.17

0.33

0

72 h (Day 3)

0

0

0

0

0

0

Mean

0.06

0.06

0.06

0.33

0.44

0

Reversibility

Completely

reversible

Completely

reversible

Completely

reversible

Completely

reversible

Completely reversible

-

Average time for reversion

2 days

2 days

2 days

3 days

3 days

-

 

Table 7.3.2/2: Eye irritation response data for each animal at each observation time

 

Score at time point

Cornea

Iris

(/2)

Conjunctivae

Opacity

(/4)

Area

(/4)

Redness

(/3)

Chemosis

(/4)

Discharge

(/3)

24 h (Day 1)

0 / 0 / 0 / 0 / 0 / 1

0 / 0 / 0 / 0 / 0 / 1

0 / 0 / 0 / 0 / 0 / 1

1 / 1 / 0 / 1 / 1 / 1

1 / 1 / 0 / 1 / 2 / 1

0 / 0 / 0 / 0 / 0 / 0

48 h (Day 2)

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 1

0 / 0 / 0 / 1 / 1 / 0

0 / 0 / 0 / 0 / 0 / 0

72 h (Day 3)

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

Average 24h, 48h, and 72h

0 / 0 / 0 / 0 / 0 / 0.33

0 / 0 / 0 / 0 / 0 / 0.33

0 / 0 / 0 / 0 / 0 / 0.33

0.33 / 0.33 / 0 / 0.33 / 0.33 / 0.67

0.33 / 0.33 / 0 / 0.67 / 1.00 / 0.33

0 / 0 / 0 / 0 / 0 / 0

Reversibility

Completely

reversible

Completely

reversible

Completely

reversible

Completely

reversible

Completely reversible

-

Average time (unit) for reversion

2 days

2 days

2 days

3 days

3 days

-

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test material is not classified as irritating to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and tot he GHS.
Executive summary:

In an eye irritation study, 0.1 mL of undiluted test material was instilled into one eye of 6 albino rabbits while the contralateral eye remained untreated and served as control. The eyes were not rinsed after the instillation of test material. Animals were observed at 24, 48 and 72 after instillation. The reactions in the conjunctivae (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize Scale.

The calculated mean score for each individual lesion for all the animals within 3 scoring times (24, 48 and 72 h) were: 0.33 for redness, 0.44 for chemosis, 0.06 for iris lesions, 0.06 for corneal opacity and 0.0 for discharge.

The calculated mean score for each individual lesion for each individual animal within 3 scoring times (24, 48 and 72 hrs) were as follows:  0.33 / 0.33 / 0 / 0.67 / 1.00 / for chemosis;  0.33 / 0.33 / 0 / 0.33 / 0.33 / 0.67 for redness; 0/0/0/0 for discharge; 0 / 0 / 0 / 0 / 0 / 0.33 for iris lesions and  0 / 0 / 0 / 0 / 0 / 0.33 for corneal opacity.

Animals showed corneal and iridial reactions which were reversible within 2 days. Conjunctival reactions (redness and chemosis) were reversible within 3 days. 

Under the test conditions, the test material is not classified as irritating to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

Although some details on experimental conditions were missing, this study is considered as acceptable and satisfies the requirement for eye irritation endpoint.