Hydrocarbons, C7-C9, isoalkanes

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 September 2000 - 26 July 2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C7-C9, isoalkanes

EC Number:

921-728-3

Cas Number:

64741-66-8

Molecular formula:

None available - not a single isomer - see remarks

IUPAC Name:

Hydrocarbons, C7-C9, isoalkanes

Details on test material:

- Name of test material (as cited in study report): MRD-00-749
- Substance type: colourless liquid
- Physical state: colourless liquid
- Analytical purity:100% pure commercial product
- Expiration date of the lot/batch: November 2005
- Storage condition of test material: room temperature
- pH: 5

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products Inc. (formerly HRP), Denver, PA, USA
- Age at study initiation: approximately 15 - 16 weeks
- Weight at study initiation: 2.41 - 2.73 kg
- Housing: single housed during study; suspended stainless steel and wire mesh with absorbent paper below cages
- Diet (e.g. ad libitum): PMI Certified Rabbit Diet 5322; feed was analysed and not contaminated; the animals received new feed each day and the old feed, if any, was discarded. Availability of feed was checked at least once daily for all animals.
- Water (e.g. ad libitum): ad libitum, automatic watering system; water was analysed and not contaminated; availability of water was checked at least once daily for all animals
- Acclimation period: 22 days; animals were examined for viability at least once daily
- Other: animal identification by ear tags and corresponding cage identification


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8 - 22.2°C (64 - 72 degrees Fahrenheit)
- Humidity (%): 30 - 70 % relative humidity
- Photoperiod (hrs dark / hrs light): approx. 12 h light (06.00 - 18.00) and 12 h dark (18.00 - 06.00)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

see observation period: The test substance was not washed out.

Observation period (in vivo):

1, 24, 48, 72 hours and 7 days

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize Standard Eye Irritation Grading Scale (Draize 1959: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the US, vol. 49, pp. 2-56.

TOOL USED TO ASSESS SCORE: 2 % sodium fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effect

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Irritant / corrosive response data:

Ocular instillation of the test substance elicited conjunctival responses in all animals. Iridic and corneal responses were not evident during the study. Conjunctival responses consisted of redness of Grade 2 in all animals and discharge of Grade 1 and Grade 2 for one animal each at the 1 hour evaluation. Discharge was not evident after the 1 hour evaluation but redness of Grade 1 was noted for 2 animals at the 24 and 48 hour evaluations. Redness of Grade 1 also was noted for all animals at 72 hour evaluation. Irritation was not evident at the Day 7 evaluation and the study was terminated.

Other effects:

All animals survived the study termination and were free of clincial signs during the study.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: other: GHS (EU, 2007)

Conclusions:

Based on the study design the test substance, hydrocarbons, C7-C9, isoalkanes, is not irritating.

Executive summary:

Based on the study design the test substance, Hydrocarbons, C7-C9, isoalkanes, is not irritating.