Hydrocarbons, C7-8

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Principles of method if other than guideline:

according to the Federal Register of the F.D.A. 28 (110), 6.6.1963, para. 191.12. Test for eye irritants

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics

IUPAC Name:

Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics

Details on test material:

- Name of test material (as cited in study report): SBP 100/140
- Analytical purity: 100% pure commercial product
- Composition of test material, percentage of components: low aromatic content solvent consisting of about 35% C7, 50% C8 and 15% C9 saturated hydrocarbon isomers

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS- Strain: albino- Source: Ranch Rabbits, Crawley, Sussex- Weight at study initiation: 3 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

0.2 mL

Duration of treatment / exposure:

single application

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

2 males, 2 females

Details on study design:

Undiluted solvent was instilled into the conjunctival sac of the right eye of two male and two female albino rabbits; the untreated left eye served as a control. A visual assessment of irritancy was made half an hour after application and again 1, 2, 3 and 7 days later.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 0.5 hrs - 7 days

Score:

0

Max. score:

4

Reversibility:

not specified

Any other information on results incl. tables

Conjunctiva redness, chemosis and discharge, Cornea opacity and area, and Iris were scored in 4 animals. In all 4 animals only at timepoint 0.5 hr a very mild irritancy was observed in conjunctiva redness and scored 0 - 1. Thus the overall score can be considered to be 0.

Table: Individual Eye Irritation Scores

Animal		1/2 hr	24 hrs	48 hrs	72 hrs	7 days
1351 Female	Cornea, opacity	0	0	0	0	0
	Cornea, area	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctiva, redness	0-1	0	0	0	0
	Conjunctiva, chemosis	0	0	0	0	0
	Conjunctiva, discharge	0	0	0	0	0
1352 Male	Cornea, opacity	0	0	0	0	0
	Cornea, area	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctiva, redness	0-1	0	0	0	0
	Conjunctiva, chemosis	0	0	0	0	0
	Conjunctiva, discharge	0	0	0	0	0
1422 Female	Cornea, opacity	0	0	0	0	0
	Cornea, area	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctiva, redness	0-1	0	0	0	0
	Conjunctiva, chemosis	0	0	0	0	0
	Conjunctiva, discharge	0	0	0	0	0
1423 Male	Cornea, opacity	0	0	0	0	0
	Cornea, area	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctiva, redness	0-1	0	0	0	0
	Conjunctiva, chemosis	0	0	0	0	0
	Conjunctiva, discharge	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: other: EU, GHS, 2007

Conclusions:

The purpose of this test was to determine the irritation potential of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics to rabbit eye. 0.2 mL of test substance was added to the right eye of two male and two female rabbits. The animals were scored for irritation at 0.5 hrs after applications, and also at 1, 2, 3, and 7 days after application. All animals showed conjunctival redness (score of 0-1) at the 0.5 hr observation. No other signs of irritation were noted. The test substance is not irritating to eyes according to OECD GHS guidelines.

Executive summary:

The purpose of this test was to determine the irritation potential of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics to rabbit eye. 0.2 mL of test substance was added to the right eye of two male and two female rabbits. The animals were scored for irritation at 0.5 hrs after applications, and also at 1, 2, 3, and 7 days after application. All animals showed conjunctival redness (score of 0-1) at the 0.5 hr observation. No other signs of irritation were noted. The test substance is not irritating to eyes according to OECD GHS guidelines.