Reaction products of petrolatum (petroleum), oxidized, esterified with methanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 December 2000 to 22 December 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts

EC Number:

271-638-7

EC Name:

Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts

Cas Number:

68603-11-2

Molecular formula:

not available

IUPAC Name:

Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts

Test material form:

other: semi-solid

Details on test material:

- Physical state: brown semi-solid
- Storage condition of test material: room temperature and humidity

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA, USA
- Weight at study initiation: 2.4 - 2.7 kg
- Housing: individually in suspended cages. Bedding was placed underneath cages and changed three times per week.
- Diet: Fresh Purina Rabbit Chow (Diet #5321) was provided daily
- Water: ad libitum
- Acclimation period: at least 5 days
- Health: all animals were found to be free from evidence of ocular irritation or abnormalities before being assigned to the study

ENVIRONMENTAL CONDITIONS
- Animals were placed in a temperature controlled room which had a 12 hour light/dark cycle

IN-LIFE DATES: From: 29 November 2000 To: 22 December 2000

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

Duration of treatment / exposure:

- Dose administration: Approximately 0.1 mL of the test material was placed by syringe into the conjunctival sac which was formed by gently pulling the lower eyelid away from the eye. After instillation, the lids were held together for approximately one second to insure adequate distribution of the test material. One eye of each rabbit was dosed. The contralateral eye served as a control.

Observation period (in vivo):

Animals were observed for 72 hours post administration.

Number of animals or in vitro replicates:

One animal initially, followed by a further two animals once the irritation potential was fully assessed in the first animal.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Not reported

SCORING SYSTEM
- The reactions observed were scored 1, 24, 48 and 72 hours post administration, in accordance with the criteria of Draize. The scale for scoring ocular reactions is presented as Table 1 in the field "Any other information on materials and methods incl. tables".
- Bodyweights were recorded pre-test
- The general health of the animals was monitored at each observation time

TOOL USED TO ASSESS SCORE
- Sodium fluorescein dye was used at the 24 hour observation interval. These examinations were performed using a Mini-Maglite flashlight equipped with a high intensity bulb.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable - no reactions seen

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: not applicable - no reactions seen

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

other: discharge

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.22

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation noted in all 3 eyes, cleared by 72 hours.

Other effects:

There were no abnormal physical signs noted during the observation period.

Any other information on results incl. tables

Table 2: Results

Animal	Tissue	Reading	1 hour	24 hours	48 hours	72 hours
1 M	Cornea	Opacity	0	0	0	0
		Area	0	0	0	0
		1. Total	0	0	0	0
	Iris		0	0	0	0
		2. Total	0	0	0	0
	Conjunctiva	Redness	2	2	2	0
		Chemosis	1	1	0	0
		Discharge	2	1	0	0
		3. Total	10	8	4	0
	Total = 1 + 2 + 3		10	8	4	0
	Systemic observations		A	A	A	A
	Sodium fluorescein			0
	Pre-test bodyweight		2.4 kg
2 M	Cornea	Opacity	0	0	0	0
		Area	0	0	0	0
		1. Total	0	0	0	0
	Iris		0	0	0	0
		2. Total	0	0	0	0
	Conjunctiva	Redness	1	1	1	0
		Chemosis	1	0	0	0
		Discharge	1	0	0	0
		3. Total	6	2	2	0
	Total = 1 + 2 + 3		6	2	2	0
	Systemic observations		A	A	A	A
	Sodium fluorescein			0
	Pre-test bodyweight		2.7 kg
3 M	Cornea	Opacity	0	0	0	0
		Area	0	0	0	0
		1. Total	0	0	0	0
	Iris		0	0	0	0
		2. Total	0	0	0	0
	Conjunctiva	Redness	2	2	1	0
		Chemosis	1	1	1	0
		Discharge	2	1	0	0
		3. Total	10	8	4	0
	Total = 1 + 2 + 3		10	8	4	0
	Systemic observations		A	A	A	A
	Sodium fluorescein			0
	Pre-test bodyweight		2.5 kg

 

A = Normal

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

Under the conditions of the study, the test material only elicited slight reactions in the animals during the course of the study that meant the test material does not require classification as an eye irritant in accordance with EU criteria. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.

Executive summary:

The eye irritation potential of the test material was determined in accordance with the standardised guideline EPA OPPTS 870.2400. During the study, 0.1 mL of test material was applied into one eye of three New Zealand White rabbits; the animals were assessed for 72 hours to determine the grade of ocular reaction.

There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, which was noted in all three treated eyes, had fully cleared by 72 hours.

Under the conditions of the study, the test material only elicited slight reactions in any of the animals during the course of the study that meant the test material does not require classification as an eye irritant in accordance with EU criteria.