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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:
2nd February 2001 to 18th July 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Hydrocarbon waxes (petroleum), oxidized
EC Number:
265-205-1
EC Name:
Hydrocarbon waxes (petroleum), oxidized
Cas Number:
64743-00-6
Molecular formula:
too complex
IUPAC Name:
Hydrocarbon waxes (petroleum), oxidized
Test material form:
other: greasy solid
Details on test material:
- Storage: at room temperature and humidity.
- Physical appearance: Light brown semi-solid.
- TAN: 112-128

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry , Harvey's Lake, PA on 20/12/00 and 17/01/00.
- Eyes were examined before selection and assignment to the study.
- Age at study initiation: Animals were born on 08/10/00 and 02/11/00.
- Weight at study initiation: 2.1 - 2.4 kg.
- Housing: Individually in suspended cages.
- Diet (e.g. ad libitum): Purina Rabbit Chow Diet #5321, provided daily.
- Water (e.g. ad libitum): ad libitum.
- Quarantine period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled.
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml.
- Concentration (if solution): Used as supplied.
Observation period (in vivo):
Up to 21 days post exposure at the following time points; 1, 24, 48 and 72 hours, including days 7, 14 and 21.
Number of animals or in vitro replicates:
Three in total, 1 male and 2 females.
Details on study design:
TEST PROCEDURE:
- One female animal was tested initially, then based on this reaction a further two were tested.
- The test material was placed into the conjunctival sac of one eye, formed by gently pulling the lower eyelid from the eye. The lids were held together for one second before the animal was released.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not performed.

OBSERVATIONS:
-Bodyweight, was recorded before the exposure.
- Any additional signs and the general health of the animals was recorded throughout the study.

SCORING SYSTEM: Draize scale (1977), which can be seen in table 1.

TOOL USED TO ASSESS SCORE:
- Sodium fluorescein dye was used at the following time points; 24, 48 and 72 hours and days 7, 14 and 21.
- Observations were made using a Mini-Maglit®.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 21 days in the female and 14 days in the male
Remarks on result:
other: Score of opacity
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 21 days in the female and 14 days in the male
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 days in the female and 14 days in the male
Remarks on result:
other: Score for redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours.
Score:
2.6
Max. score:
4
Reversibility:
fully reversible within: 21 days in the female and 14 days in the male
Irritant / corrosive response data:
Corneal opacity, noted in 3/3 eyes, cleared by day 21. Iritis, noted in 2/3 eyes, cleared by day 7.
Conjunctival irritation, noted in 3/3 days, cleared by day 21.
Other effects:
An instance of diarrhoea was the only abnormal physical sign noted during the study.

One animal was sacrificed on day 11 due to an injury not concurrent with treatment, the animal was replaced. None of the results from the sacrificed animal have been used in the study. This replacement is not thought to have affected the results of the study.

Any other information on results incl. tables

Table 2. Ocular Response

Animal No. and Sex Tissue Reading 1 hr 24 hrs 48 hrs 72 hrs day 7 day 14 day 21
Female 1 Cornea Opacity 0 0 2 0 0 0 0
  Area 0 0 1 0 0 0 0
SubTotal   0 0 10 0 0 0 0
Iris   0 0 0 0 0 0 0
SubTotal   0 0 0 0 0 0 0
Conjunctiva Redness 2 2 2 2 1 1 0
  Chemosis 3 3 3 2 2 0 0
  Discharge 2 2 2 2 1 0 0
SubTotal   14 14 14 12 8 2 0
Total   14 14 24 12 8 2 0
Male 1 Cornea Opacity 0 2 2 2 0 0  
  Area 0 1 1 1 0 0  
SubTotal   0 10 10 10 0 0  
Iris   1 0 0 0 0 0  
SubTotal   5 0 0 0 0 0  
Conjunctiva Redness 2 2 2 2 1 0  
  Chemosis 3 3 2 2 0 0  
  Discharge 2 2 2 1 0 0  
SubTotal   14 14 12 10 2 0  
Total   19 24 22 20 2 0  
Female 2 Cornea Opacity 0 0 2 2 2 2 0
  Area 0 0 2 2 2 1 0
SubTotal   0 0 20 20 20 10 0
Iris   0 1 1 1 0 0 0
SubTotal   0 5 5 5 0 0 0
Conjunctiva Redness 2 2 2 2 2 0 0
  Chemosis 3 3 3 3 2 0 0
  Discharge 2 2 2 1 0 0 0
SubTotal   14 12 14 12 8 0 0
  Total   14 19 39 37 28 10 0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the test material was determined to be an eye irritant. Three out of three animals scored ≥ 2 for conjunctival redness and chemosis, which were observed to be fully reversible within 21 days. The material tested in this study has a TAN range of 112-128 and is classified as Eye Irritation Category 2 according to EU CLP Regulation No. 1272/2008.
Executive summary:

In a GLP compliant eye irritation study, the ocular reaction caused by exposure to the test material was determined according to EPA OPPTS 870.2400. Three rabbits were exposed to the unchanged test material and observed over a 21 day period. Three out of three animals scored ≥ 2 for conjunctival redness and chemosis, which were observed to be fully reversible within 21 days. The material tested in this study has a TAN range of 112-128 and based upon these results is classified as Eye Irritation Category 2 according to EU CLP Regulation No. 1272/2008. Corneal opacity and iritis were also observed in the test animals; however these symptoms were not severe enough to contribute to the classification.

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