Alkenes, C6-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restrictions because it was conducted according to GLP guidance and OECD 405 guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alkenes, C6-8

IUPAC Name:

Alkenes, C6-8

Details on test material:

- Name of test material (as cited in study report): SHOP C68 Internal Olefin
- Substance type: Alkenes, C6-8
- Physical state: Liquid (clear, colourless)
- Lot/batch No.: 168082
- Storage condition of test material: Cool conditions (not exceeding 13 degrees C), under nitrogen, protected from light, in original container

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Froxfield SPF Rabbits, Broadway Farm, Froxfield, Hampshire, England.
- Age at study initiation: Approximately 4 months old
- Weight at study initiation: 2.8 to 3.35 kg
- Housing: Individually in suspended stainless steel cages mounted in mobile batteries. The cages were fitted with perforated countersunk floor panels. A tray beneath the floor was lined with absorbent paper which was changed at regular intervals.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Health status of each animal was monitored and a record kept. Both eyes of all animals were examined before administration of test material for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used in this study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 19
- Humidity (%): 38 to 60
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

Dose was instilled into the right eye by pulling the lower eyelid away from the eyeball to form a cup into which the test material was dropped. The eyelids were gently held together for 1 second and then released.

Observation period (in vivo):

1, 24, 48, and 72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

TOOL USED TO ASSESS SCORE: Opthalmoscope or pencil beam torch was used to facilitate inspection of the eyes.
Fluorescein was used from the 24-hour period onward to aid cornea examination.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

corneal opacity

Basis:

mean

Time point:

other: 24,48, and 72 hours

Score:

0

Results 2

Irritation parameter:

other: Iridial lesions

Basis:

mean

Time point:

other: 24,48, and 72 hours

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness of conjunctivae

Basis:

mean

Time point:

other: 24, 48, and 72 hours

Score:

0.2

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24,48, and 72 hours

Score:

0

Any other information on results incl. tables

Grade for Ocular Irritation Responses

 

Animal No. and Sex: 498F		Pain Evaluation Response: 1
Region of the Eye	Response	Grade of Response at time after instillation (hours)
		1	24	48	72
Cornea	Opacity	0	0	0	0
	Area	0	0	0	0
	Ulceration	-	-	-	-
	Stippling	-	-	-	-
Iris	Value	0	0	0	0
Conjunctiva	Redness	2	0	0	0
	Chemosis	1	0	0	0
	Discharge	1	0	0	0
	Necrosis	-	-	-	-
	Ulceration	-	-	-	-

 

Animal No. and Sex: 28TD786F		Pain Evaluation Response: 1
Region of the Eye	Response	Grade of Response at time after instillation (hours)
		1	24	48	72
Cornea	Opacity	0	0	0	0
	Area	0	0	0	0
	Ulceration	-	-	-	-
	Stippling	-	-	-	-
Iris	Value	0	0	0	0
Conjunctiva	Redness	1	1	1	0
	Chemosis	0	0	0	0
	Discharge	0	0	0	0
	Necrosis	-	-	-	-
	Ulceration	-	-	-	-

 

Animal No. and Sex: 28TD799F		Pain Evaluation Response: 1
Region of the Eye	Response	Grade of Response at time after instillation (hours)
		1	24	48	72
Cornea	Opacity	0	0	0	0
	Area	0	0	0	0
	Ulceration	-	-	-	-
	Stippling	-	-	-	-
Iris	Value	0	0	0	0
Conjunctiva	Redness	1	0	0	0
	Chemosis	1	0	0	0
	Discharge	0	0	0	0
	Necrosis	-	-	-	-
	Ulceration	-	-	-	-

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test, SHOP C68 is considered to be a non-irritant to the eye.

Executive summary:

In a primary eye irritation study, 0.1 mL of SHOP C68 internal olefin was instilled the conjunctival sac of the right eye in 3 New Zealand White rabbits. Animals then were observed at 1, 24, 48, and 72 hours. Irritation was scored by the guidelines.

 

Initial instillation of the test compound caused very slight initial pain response. All animals had very slight to slight conjunctivitis within an hour of treatment, but one animal showed persistent response at 48 hours. At 72 hours, all animals’ eyes appeared normal.In this study, SHOP C68 internal olefin is a non-irritant to the eye. 

 

This study received a Klimisch score of 1 and is classifiedas reliable without restrictions because it was conducted according to GLP guidance and OECD 405 guidelines.