Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
According to OECD 405
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 October 1982 to 25 October 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
other: Procedure similar to the proposed guidelines of the United States EPA, Paragraph 163.81-4 “Primary eye irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978
Deviations:
yes
Remarks:
The procedure was based upon the guideline but was not in every part identical.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
The animals were not evaluated 60 minutes after exposure and the observation period lasted only 7 days.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid that tends to crystallise
Details on test material:
- Appearance: clear liquid, tends to crystallise

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Housing: Individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 4 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): Approximately 15 per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light per day.

IN-LIFE DATES: From: 18 October 1982 To: 25 October 1982

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye of each animal remained untreated and served as concurrent control.
Amount / concentration applied:
- Volume: 0.1 mL
Duration of treatment / exposure:
After insertion of the test material into the conjunctival sac, the eyelids were gently closed for 15 seconds.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
9; 6 male and 3 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 of the 9 rabbits the eye was flushed with 10 mL of sterile physiological saline
- Time after start of exposure: approximately 30 seconds after treatment

SCORING SYSTEM:
- Eyes were scored according to the Draize scale (1977)

TOOL USED TO ASSESS SCORE: slit-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: PII
Basis:
mean
Time point:
other: 7 days
Score:
29.6
Remarks on result:
other: Unrinsed eyes
Irritation parameter:
other: PII
Basis:
mean
Time point:
other: 7 days
Score:
22.1
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean of 24, 48 and 72 hour evaluations
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Unrinsed eyes
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean of 24, 48 and 72 hour evaluations
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean of 24, 48 and 72 hour evaluations
Score:
0.5
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Unrinsed eyes
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean of 24, 48 and 72 hour evaluations
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean of 24, 48 and 72 hour evaluations
Score:
2.9
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Unrinsed eyes
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean of 24, 48 and 72 hour evaluations
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean of 24, 48 and 72 hour evaluations
Score:
2.8
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Unrinsed eyes
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean of 24, 48 and 72 hour evaluations
Score:
2.7
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Rinsed eyes
Irritation parameter:
other: discharge
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean of 24, 48 and 72 hour evaluations
Score:
2.7
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Unrinsed eyes
Irritation parameter:
other: discharge
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean of 24, 48 and 72 hour evaluations
Score:
2.6
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Rinsed eyes
Irritant / corrosive response data:
The test material was found to cause moderate irritation.
Other effects:
No other effects reported.

Any other information on results incl. tables

Table 1 Calculation of Primary Eye Irritation Index

Time After Exposure Mean Reaction Score
Unrinsed Eyes Rinsed Eyes
Cornea Iris Conjunctiva Cornea Iris Conjunctiva
24 hrs 11.7 2.5 17.0 10.0 0.0 16.0
48 hrs 13.3 2.5 16.7 10.0 0.0 18.0
72 hrs 14.2 2.5 16.7 10.0 0.0 15.3
4 days 14.2 2.5 14.0 8.3 0.0 10.0
7 days 10.0 1.7 8.7 6.7 0.0 6.0
Subtotal 63.4 11.7 73.1 45.0 0.0 65.3
Total 148.2   110.3  
PII 29.6     22.1    

Table 2 Individual Irritation Scores at 24, 48, 72 hours and days 4 and 7

Unrinsed   Rinsed  
Observation Time Observation Male 1 Male 2 Male 3 Female 1 Female 2 Female 3 Average Male 4 Male 5 Male 6 Average
24 hrs Opacity 1 1 1 1 1 1 1.0 1 1 1 1.0
  Iris 1 1 1 0 0 0 0.5 0 0 0 0.0
  Conjunctivae 3 3 3 3 3 3 3.0 3 3 3 3.0
  Chemosis 3 3 3 3 3 2 2.8 3 2 3 2.7
48 hrs Opacity 1 1 1 1 1 1 1.0 1 1 1 1.0
  Iris 1 1 1 0 0 0 0.5 0 0 0 0.0
  Conjunctivae 3 3 3 3 3 2 2.8 3 3 3 3.0
  Chemosis 3 3 3 3 3 1 2.7 3 3 3 3.0
72 hrs Opacity 1 1 1 1 1 1 1.0 1 1 1 1.0
  Iris 1 1 1 0 0 0 0.5 0 0 0 0.0
  Conjunctivae 3 3 3 3 3 3 3.0 3 3 3 3.0
  Chemosis 3 3 3 2 3 3 2.8 3 2 2 2.3
4 days Opacity 1 1 1 1 1 1 1.0 1 1 1 1.0
  Iris 1 0 1 0 1 0 0.5 0 0 0 0.0
  Conjunctivae 3 3 2 3 3 3 2.8 2 2 2 2.0
  Chemosis 2 2 2 2 2 3 2.2 2 2 2 2.0
7 days Opacity 1 1 1 1 1 1 1.0 1 1 1 1.0
  Iris 1 0 1 0 0 0 0.3 0 0 0 0.0
  Conjunctivae 2 1 2 2 2 1 1.7 1 2 1 1.3
  Chemosis 2 1 2 2 2 1 1.7 1 1 1 1.0

Applicant's summary and conclusion

Interpretation of results:
other: Category 2
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the test material was shown to be irritating to the eyes. In accordance with EU criteria the test material is classified as Category 2.
Executive summary:

The eye irritancy potential of the test material was assessed in a GLP compliant in vivo study that was based upon the procedure outlined in the guidelines of the United States EPA, Paragraph 163.81-4 “Primary eye irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978.

Nine New Zealand White rabbits were exposed to the test material; the treated eye of three animals was rinsed with saline 30 seconds after exposure. The reactions to the test material were evaluated in accordance with the Draize scale (1977) after 24, 48 and 72 hours followed by further observations after 4 and 7 days. The test material was determined to cause moderate irritation.

 

Under the conditions of this study, the test material was shown to cause irritation to the eye which would require classification under regulation directive 1272/2008. The test material requires classification as "Category 2, H319: Causes serious eye irritation" with signal word "Warning".