Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted

Eye irritation

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Light paraffinic distillate solvent extract (CAS# 64742-05-8)

IUPAC Name:

Light paraffinic distillate solvent extract (CAS# 64742-05-8)

Details on test material:

Treated distillate aromatic extracts (TDAEs) are a further processing of distillate aromatic extracts (DAEs) in an attempt to reduce the amount of 3-7 ring PAC that is present. Since the treatment is mostly a selective reduction of PACs, the data from DAEs can serve as read across where treatment was insufficient and a significant amount of PACs still remain (≥ 3 wt% DMSO extractables as measured by IP-346). 

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

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 to 72 hours

Score:

0

Max. score:

80

Remarks on result:

other: unwashed eyes

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 to 72 hours

Score:

0

Max. score:

10

Remarks on result:

other: unwashed eyes

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 to 72 hours

Score:

0.44

Max. score:

20

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: unwashed eyes

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

Treated distillate aromatic extracts (TDAEs) are a further processing of distillate aromatic extracts (DAEs) in an attempt to reduce the amount of 3-7 ring PAC that is present. Since the treatment is mostly a selective reduction of PACs, the data from DAEs can serve as read across where treatment was insufficient and a significant amount of PACs still remain (≥ 3 wt% DMSO extractables as measured by IP-346). Where treatment was sufficient to reduce the 3-7 ring PACs (<3 wt% DMSO extractables as measured by IP-346), the material is most similar to a lubricating base oil and it is this data that should be used for read across. 

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 9white 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). For purposes of classification and labelling and registration under REACH aromatic extracts are sub-divided into the categories of untreated 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 TDAEs are not subclassified based on crude oil source or viscosity, i.e., for any health endpoint data from any one of the untreated DAEs can be “read-across” to the remaining DAEs and whole TDAE category.

 

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.