Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it is conducted similar to OECD Test Guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
RAEs are not expected to be more hazardous than DAE; therefore, read across to DAEs represents a conservative approach.

- Name of test material (as cited in study report): API 83-16, CAS No. 64742-05-8
- Physical state: liquid, brown

- Viscosity, SSU: 67.2 at 100°F
- API Gravity: 16.7
- Flash Point: (°F) 335
- Pour Point (°F): 20
- Aniline Point (°F): 95.5
- Sulfur, Wt %: 2.64

- Composition of test material ASTM D-2007, Wt. %:
Saturates: 29.2
Aromatics 68.6

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver, Pennsylvania
- Weight at study initiation: 2,500 to 3,320 grams
- Housing: maintained individually in screen-bottom cages
- Diet (e.g. ad libitum): Purina certified rabbit chow 5322, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24
- Humidity (%): 64 to 70
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 12/04/84 To: 12/11/84

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Group II animals had eyes flushed for 1 minute, 20 to 30 seconds after test material instillation
Observation period (in vivo):
1, 24, 48, 72 hours and at 7 days
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Group II animals had treated and control eye flushed for 1 minute with lukewarm water starting 20 to 30 seconds after test material instillation
- Time after start of exposure: 20 to 30 seconds


SCORING SYSTEM: Draize (1959)


TOOL USED TO ASSESS SCORE: Sodium fluorescein was used to aid revealing possible corneal injury

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
80
Remarks on result:
other: unwashed eyes
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
10
Remarks on result:
other: unwashed eyes
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
20
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: unwashed eyes
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: included within conjunctivae score
Irritant / corrosive response data:
No corneal or iridal irritation was seen during the study. Blanching in the conjuctivae was seen in one animal at the 1-hour observation. All irritation had cleared by the 48-hour observation.
Other effects:
No pain response was elicited from any animal following instillation. One animal in Group I was found dead on day 5. No sign of ill health was observed during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean cornea, iris, conjuctivae scores (24 to 72 hours) were 0.0, 0.0, and 0.44, respectively. The test material is classified as not irritating to the eye according to EU criteria.
Executive summary:

Justification for Read Across

For purposes of classification and labelling and registration under REACH, aromatic extracts are sub-divided into the categories of distillate aromatic extracts (DAE), treated distillate aromatic extracts (TDAE), and residual aromatic extracts (RAE). Some of the classifications are based on 3-7 ring PAC content, which is not substantively affected by whether the aromatic extract is derived from paraffinic or naphthenic or “light” or “heavy” crude. Therefore, DAEs and RAEs are not subclassified based on crude oil source or viscosity. For most health endpoints, data from any one of the DAEs can be “read-across” to the remaining DAEs and whole RAE category.

 

In a primary eye irritation study, 0.1 mL of undiluted light paraffinic distillate solvent extract was instilled into the conjunctival sac of one eye of 9 white rabbits. Group I animal eyes remained unwashed, while Group II animal eyes were flushed with water for 1 minute, 20 to 30 seconds after instillation. Animals then were observed for 7 days. Irritation was scored by the method of Draize (1959).

The mean cornea, iris, conjuctivae scores (24 to 72 hours) were 0.0, 0.0, and 0.44, respectively. In this study, light paraffinic distillate solvent extract is not an eye irritant. The test material is classified as not irritating to the eye according to EU criteria. 

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because it is conducted similar to OECD Test Guideline 405.